Cost analysis of elective rotational atherectomy in patients with coronary lesions with severe obstruction and calcification and chronic renal failure (CKD) versus the conventional rescue rotational atherectomy strategy

Inclusion criteria:

• Patients older than 18 years
• Patients with GFR less than 60 ml/min/1,73 m2.
• Severe coronary angiography calcification (both sides of the artery)
• Stenosis > or = 70% by visual estimation in a coronary artery greater than 2,5 mm.
• Any clinical scenario except AMI (in the first 7 days of evolution).

Exclusion criteria:

• AMI in the first 7 days of evolution.
• Injury to a single patent vessel.
• Patients with calcified lesions with an angulation >60º, dissections, lesions with thrombus and degenerated saphenous bridges.
• Patients with clinical or hemodynamic instability,
• Patients with allergies to iodinated contrast agents
• Patients with significant comorbidity and a life expectancy of less than 1 year

The purpose of this study is to determine if CAEL-101 improves overall survival in patients with cardiac AL amyloidosis.

Inclusion criteria

Patients eligible for inclusion in this study must meet all of the following criteria:

• AL amyloidosis in May stage IIIA or IIIb.
• Planned first-line treatment with a cyclophosphamide-bortezomib-dexamethasone-based regimen.
• Measurable hematological disease.
• Histopathological diagnosis of amyloidosis and confirmation of AL-derived amyloid deposits
• Cardiac involvement with a diagnosis of heart failure in the context of AL amyloidosis

Exclusion criteria

• Patients eligible for this study must not meet any of the following criteria:
• Any form of amyloidosis other than AL amyloidosis, or i meet the definition of multiple myeloma or POEMS syndrome.
• Previous therapy for AL amyloidosis or multiple myeloma.
• Taking prednisone (or equivalent) >10mg/day, doxycycline or receiving dialysis.
• Supine systolic blood pressure < 90mmHg, symptomatic orthostatic hypotension.

You want to evaluate the use of the AI ​​combination and the data obtained from the pacemaker allow you to find patterns or indices that predict the appearance or increase of Atrial Fibrillation.

It also wants to find patterns that predict the appearance of MACE events, hospitalizations, visits to the emergency room, generated by Atrial Fibrillation or Heart Failure.

Inclusion criteria:

Over 18 

Indication for implantation or replacement of DR or CRTp pacemakers.

Exclusion criteria

Kidney hemodialysis

Heart transplant recipient or high probability of Tx during study follow-up.

Pregnancy.

Life expectancy less than one year.

Wants to test the hypothesis that treatment with 300 milligrams (mg) of inclisiran sodium administered subcutaneously (sc)

On day 1, day 90, and every 6 months thereafter in patients at high cardiovascular (CV) risk without prior major atherosclerotic cardiovascular disease (ACAD) will significantly reduce the risk of major adverse cardiovascular events.

Inclusion criteria:

Participants of both sexes ≥40 and <80 years old.

At high risk of suffering a first MACE:

1.  Signs of atherosclerotic coronary artery disease on CT or invasive coronary angiogram defined as ≥20% and <50% stenosis in the left main artery or ≥20% and <70% stenosis in any major pericardial artery.
2. coronary artery calcium (CAC) score obtained by CT ≥ 100 Agaston units.
3. High risk of ACE at 10 years ≥ 20%.
4. Intermediate risk of ACE 10 between 7.5% and 20% with at least 2 factors that increase the risk.

• If you are receiving prior lipid-lowering treatment, you must take it for at least a month and continue with it during the study.
• LDL ≥ 70mg/dl and <190mg/dl

Exclusion criteria:

History of major ACE event defined as any of the following:

1. Acute coronary syndrome (ACS) in the 12 months before randomization,
2. Previous myocardial infarction at any time before randomization, or
3. Previous ischemic stroke
4. Peripheral arterial disease (PAD)

• Having undergone revascularization caused by ischemia in a coronary arterial bed or
• Absence of coronary atherosclerosis on CT angiography or invasive coronary angiography during the 2 years before randomization.
• Coronary artery calcium (CAC) score of 0 obtained within 2 years prior to randomization.
• Active liver disease or liver dysfunction.
• Previous, current, or planned treatment with a monoclonal antibody (MA) targeting proprotein convertase subtilisin/kexin type 9 (PCSK9) (e.g., evolocumab or alirocumab).
• Pregnant or lactating women

The primary objective of this study is to demonstrate the superiority of inclisiran compared to placebo in reducing the risk of MACE in participants with established ASCVD and an LDL-C ≥1.8 mmol/L (70 mg/dL).

Inclusion criteria:

• Man or woman ≥40 years old

• Fasting LDL-C ≥ 1,8 mmol/L (70 mg/dL) at the screening visit

• At the screening visit, participants must be stable (≥4 weeks) and on a well-tolerated lipid-lowering regimen (including, for example, with or without Ezetimibe) which must include high-intensity statin therapy with atorvastatin ≥ 40 mg QD or rosuvastatin ≥20 mg.

• Established CV disease, defined as any of the following:

• Previous myocardial infarction
• Previous ischemic stroke
• Symptomatic peripheral arterial disease (PAD).

Exclusion criteria:

•NYHA class III or IV

• Previous exposure to inclisiran or any other non-targeted PCSK9 mAb therapy, within 2 years prior to the first study visit.

• Pregnant or lactating women (infants)

• Women of childbearing potential, unless using contraception during study treatment dosing.

Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Milvexian, an oral factor XIa inhibitor, versus Apixaban in participants with atrial fibrillation.

Inclusion criteria

Medically stable and suitable for antithrombotic treatment.

Atrial fibrillation or flutter, paroxysmal or sustained, not due to a reversible cause, and eligible for anticoagulant therapy.

 The participant must meet one or both of the following risk factor categories (a or b):

a. One or more of the following risk factors:

Yo. Age ≥75 years at the time of selection

ii. History of clinically symptomatic stroke or silent cerebral infarction of any type

b. Two or more of the following risk factors:

i. Age between 65 and 74 years, inclusive, at the time of evaluation

ii. Hypertension iii. Diabetes mellitus (defined as history of diabetes mellitus and current use of antidiabetic medications)

Atherosclerotic vascular disease

The ischemic stroke must be > 7 days before the first dose of the study intervention. Hemorrhagic strokes and hemorrhagic transformations must have occurred ≥3 months previously and are permitted by investigator discretion. A prior neurology consultation is recommended to check if the patient is appropriate for anticoagulation.

Exclusion criteria

A previous disabling stroke.

Hemodynamically significant valvular disease.

Any condition other than atrial fibrillation that requires chronic anticoagulation at the discretion of the investigator.

Known presence of atrial myxoma or left ventricular thrombus.

Active endocarditis.

Current active liver disease.

Requires dialysis at time of randomization.

Patients with eGFR <25 mL/min/1,73 m2 at screening.

History of any significant drug allergies (such as anaphylaxis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia.

Hospitalized for acute heart failure at randomization.

Inability to swallow medications

It wants to demonstrate the efficacy and safety of Milvexian, an oral factor XIa inhibitor, after a recent acute coronary syndrome and to verify the reduction in the risk of major cardiovascular events.

Inclusion criteria

-Type of participant and characteristics of the disease

a) Clinical syndrome compatible with spontaneous cardiac ischemia

b) Diagnosis of acute coronary syndrome

c) Elevation of cardiac biomarkers.

-Participants must have at least 2 of the following risk factors:|

a) 65 years or older

b) Diabetes mellitus

c) History of a previous MI

d) multivessel CAD

e) History of CABG surgery before the index ACS event

f) History of PAD or cerebrovascular disease

g) Conservative management

h) One or more of the following high-risk angiographic features

to. Total stent length > 30 mm

b. Thrombotic target lesion

C. Bifurcation lesion treated with more than one stent

d. Calcified target lesion treated with atherectomy

and. Treatment of obstructive left main artery or proximal left anterior descending artery for index ACS.

Exclusion Criteria

1. MI secondary to ischemia due to increased oxygen demand or decreased supply (type 2 MI) or periprocedural MI as an index event for ACS.

2. Minimal or no obstructive CAD on angiography performed for the index ACS event prior to any PCI (i.e., <50% visual stenosis as determined by the investigator).

3. Planned CABG or staged PCI after randomization

4. Any condition requiring chronic anticoagulation at the discretion of the investigator and/or local guidelines.

5. Conditions with a significantly increased risk of bleeding

6. Requires permanent dialysis or has an eGFR <15 ml/min/1,73 m2 at screening

7. Current active liver disease

8. History of ischemic stroke or TIA

9. Killip Class 3 or 4 at the time of randomization

10. History of any significant drug allergies.

11. Known aPTT prolongation > 1,5 times ULN or known congenital FXI deficiency

The primary objective of this study is to evaluate whether abelacimab is superior to placebo in reducing the risk of ischemic stroke or systemic embolism (SE) in patients with AF who have been deemed unsuitable for oral anticoagulation therapy.

Inclusion criteria

• Diagnosed AF or atrial flutter (documented on an electrocardiogram or monitor recording)

• Age 65-74 and CHA2DS2VASc ≥4 OR age ≥75 and CHA2DS2VASc ≥3

• Judged by the responsible physician or by his/her own decision to be unsuitable for oral anticoagulation

• At least 1 of the following:

o Severe renal failure (creatinine clearance <30 ml/min by the Cockcroft-Gault formula)

o Planned daily use of aspirin, a P2Y12 inhibitor, or other antiplatelet agent for the duration of the trial

o History of bleeding from a critical area or organ or gastrointestinal bleeding

o Other conditions associated with an increased risk of bleeding (e.g., suspected bleeding disorder; chronic NSAID use (≥3 times per week); frailty; or history of multiple falls

Exclusion criteria.

• History of hypersensitivity to any of the study drugs or their excipients, to drugs of similar chemical classes

• AF due to an ongoing acute reversible cause (eg, cardiac surgery, pulmonary embolism, untreated hyperthyroidism, alcohol consumption)

• Patients who received warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban within 90 days prior to randomization

• Patients with intracranial or intraocular hemorrhage within 3 months before screening

• Mechanical heart valve or valve disease expected to require mechanical valve replacement intervention (surgical or invasive) during the course of the study

• Patients with a medical condition other than AF for whom the use of an anticoagulant is indicated

• Known presence of an atrial myxoma or left ventricular thrombus

• History or planned left atrial appendage closure or left atrial closure.

• Clinically unstable or active endocarditis or endovascular.

• Planned invasive procedure with potential for uncontrolled bleeding (e.g., major surgery)

• Hemodialysis patients in selection

• Any stroke within 14 days before randomization or TIA within 3 days before randomization

Multinational registry of patients in secondary cardiovascular prevention. Prospective non-interventional study of cardiovascular prevention.

Wants to determine whether the 2021 ESC Guidelines or the applicable National CV Disease Guidelines are followed in daily practice regarding the co-prescription of antiplatelet agents, RAAS antagonists and statins in patients undergoing secondary CV prevention after one year trackingfrom the first visit after discharge (reference date).

Inclusion criteria

1. Patients over 18 years of age and under 80 years of age.

2. Being discharged after being hospitalized for a CV event.

3. Signing of the trial-specific informed consent.

Exclusion Criteria

1. Patients with mental disabilities, with drug abuse, in hospice or others

facts that make patient participation in the study difficult.

2. Pregnant women.

To analyze the composite outcome of sudden cardiac death or sustained ventricular tachycardia (treated with ICD or documented by any diagnostic method) in chronic ischemic patients without prior evidence of arrhythmia, according to their risk classification using “B” mass.order Zone Chanels»BZC.

Inclusion criteria

Age > 18 years.

Stable chronic ischemic heart disease (>6 months after the index acute coronary event), regardless of LVEF.

Life expectancy > 1 year with good functional status

Signed informed consent.

CMR performed recently (less than 6 months) or scheduled for clinical purposes (usual clinical practice).

Exclusion criteria

Age < 18 years.

Pregnancy.

Life expectancy < 1 year, or poor functional status (NYHA functional class IV).

Other concomitant structural heart diseases (e.g., congenital, non-ischemic, etc.)

Previously documented sustained ventricular arrhythmias.

Impossibility or contraindications for performing both a contrast-enhanced CMR and a cardiac CT scan.

Concomitant investigational treatments.

Clinical assessment of the usefulness of new obstructive sleep apnea detection technologies in patients scheduled for atrial fibrillation ablation.

Inclusion criteria:

· Patients with paroxysmal or persistent atrial fibrillation scheduled for a first pulmonary vein ablation procedure.

· Patients over 18 years of age and under 70 years of age.

· Patients capable of correctly using the device and following the technical instructions required in the protocol.

· Patients with the ability to understand and offer written informed consent.

Exclusion criteria:

· Patients with already diagnosed obstructive sleep apnea.

· Patients with implantable electronic devices.

· Patients with previous pulmonary vein ablation.

· Patients with moderate or severe mitral or aortic valve disease.

· Patients with valve prostheses.

· Patients with severe dilation of the left atrium.

· Allergy to device adhesive

· Anatomical conditions (e.g. extremely lax skin on the neck) that prevent correct placement of the device.

· Functional class III-IV of the classification of heart failure, recent myocardial infarction or stroke (>3 months), cancer treated with chemotherapy, dialysis, or any other comorbidity that could affect adjustment to the protocol.

Questionnaires for the knowledge of the patient who attends a cardiology consultation.

Inclusion criteria

• Basal phase
•  Patients who attend a cardiology consultation for any reason between the ages of 18 and 80 (both values ​​included). Informed consent
• Longitudinal phase
• Patients diagnosed with arteriosclerotic cardiovascular disease (coronary or cerebrovascular, peripheral vascular) and/or type II diabetes.

Exclusion criteria.

• Longitudinal phase:
• Type 1 diabetes mellitus
• Severe valvular disease. Severe pulmonary hypertension.
• Diagnosis of advanced heart failure of non-ischemic etiology.

Randomized, placebo-controlled study to evaluate the efficacy and safety of mk-0616 in reducing adverse cardiovascular events in patients with high cardiovascular risk. (Pcsk9 in pills)

Inclusion criteria:

History of a major ASCVD event:

≥30 days after a myocardial infarction.

≥30 days after ischemic stroke (presumably due to atherosclerosis)

≥30 days after successful peripheral arterial revascularization or major amputation due to atherosclerosis

-High risk of an ASCVD event:

≥50 years with evidence of CAD

≥50 years with evidence of atherosclerotic cerebrovascular disease.

≥50 years with evidence of PAD.

≥60 years with evidence of diabetes mellitus.

≥60 years and at least 3 of these factors:

   -History of hypertension

    -LDL-C ≥130 mg/dl.

   -Active smoker.

    -More than 70 years old man, 75 years old woman.

High LDL 70 mg/dl

Use of stable statins.

Exclusion criteria

• Has a history of homozygous FH according to medical or clinical criteria.
• Had a hospitalization for heart failure within 3 months prior to randomization.
• He has recurrent episodes of ventricular tachycardia.
• Has a QTC >500ms.
• He has uncontrolled hypertension.
• You are scheduled for arterial revascularization procedure.
• He has a history of nephrotic syndrome.
• He has a history of severe kidney failure.
• Do you have any malabsorption condition (vomiting...)
• Clinically significant liver disease.
• He is receiving chemotherapy.
• Life expectancy less than 5 years

The response to beta-blockers is influenced by genetic variants, such as those in the ADRB1 and CYP2D6 genes.

These variants can determine the efficacy and safety of treatment, highlighting the importance of personalized therapy based on a patient's genetic profile. We perform whole exome sequencing (WES) on your blood sample and associate this information with your medical and/or family history. Unlike other more specific genetic tests, this study does not focus solely on one or more specific genes, but rather comprehensively analyzes all the coding genes in your DNA.

Inclusion criteria:

Exclusion criteria:

-Patients with serious comorbidities that significantly influence the response to treatment.
-Concomitant use of other medications that may interfere with the pharmacokinetics of the treatment.
-History of allergy to beta-blockers. Non-adherence to beta-blocker treatment.
-History of serious adverse effects that have led to discontinuation

To determine whether endovascular catheter-based left atrial appendage occlusion (LAAO) prevents ischemic stroke or systemic embolism in participants with atrial fibrillation (AF) who remain at high risk for stroke despite ongoing oral anticoagulant (OAC) therapy.

Inclusion criteria:

Exclusion criteria:

-Patients with serious comorbidities that significantly influence the response to treatment.
-Concomitant use of other medications that may interfere with the pharmacokinetics of the treatment.
-History of allergy to beta-blockers. Non-adherence to beta-blocker treatment.
-History of serious adverse effects that have led to discontinuation

Effects of ziltivekimab versus placebo on morbidity and mortality in patients with heart failure with mildly reduced or preserved ejection fraction and systemic inflammation.

Inclusion criteria:

Exclusion criteria:

Apixaban for the Reduction of Thromboembolism in patients with Subclinical atrial fibrillation detected by a device. The purpose of this clinical trial was to determine which treatment is best for preventing stroke or systemic embolism in patients who have experienced at least one episode of atrial fibrillation detected by a device and who also have other risk factors for stroke.

He dedicated himself to the adaptation of therapeutic strategies used in patients with stable atherosclerotic disease and the use of recommended treatments according to clinical guidelines.

Study published in The New England Journal of Medicine

The study studied patients who were candidates for percutaneous aortic valve implantation and had previously been anticoagulated for atrial fibrillation. They were randomized to anticoagulation with Sintrom vs. Edoxaban (a new oral anticoagulant). The objective was to assess the incidence of cardiovascular events and complications derived from anticoagulation in both groups.

It is planned to soon begin taking part in new clinical trials also aimed at expanding knowledge in cardiology and providing the best care to our patients.

Studied the impact of the implementation of the Spanish Consensus on LDL cholesterol control rates among patients admitted for Acute Coronary Syndrome (ACS).

Studied the behavior of edoxaban in non-valvular atrial fibrillation (NVAF) and heart failure (HF).

It studied the efficacy, defined as success of the procedure defined as performance of intracoronary lithotripsy without in-hospital complications with good angiographic result.

To know the perception that patients have of the risk of debut or recurrence of cardiovascular events; as well as the knowledge and perception that health personnel have about the importance of the adequate transmission of information about risky situations.

Inclusion criteria:

• All patients ≥18 years of age admitted to Cardiology hospitalization (ward and coronary unit, if the center has one) on an urgent or scheduled basis during the selection period.

• Patient whose treating physician consents to participate in the study.

- Exclusion criteria:

• Inability to complete a questionnaire secondary to physical or mental condition (e.g. significant cognitive impairment).

• Not signing informed consent.

Wants to make a clinical assessment of the usefulness of new electrocardiographic heart rate monitoring technologies in patients scheduled for outpatient electrical cardioversion for atrial fibrillation

Inclusion criteria:

ï Patients with paroxysmal, persistent or newly diagnosed atrial fibrillation, symptomatic or not scheduled for outpatient electrical cardioversion.

ï Patients older than 18 years.

ï Patients with mobile devices compatible with Kardia and capable of using the devices and transmitting the ECG recordings required in the protocol.

ï Patients with the ability to understand and offer written informed consent.

Exclusion criteria:

ï Patients with atrial fibrillation of estimated origin > 3 months.

ï Patients with cardiac stimulation devices (e.g. pacemakers, defibrillators...)

ï Patients with severe dilation of the left atrium (AP diameter ≥ 5.2 cm in men or ≥ 4.7 cm in women).

ï Patients with recent failed electrical cardioversion (3 months), cancer treated with chemotherapy, dialysis, or any other comorbidity that could affect adjustment to the protocol.

ï Life expectancy of less than 6 months for any reason.

The trial will examine the benefits of dapagliflozin treatment in patients with severe aortic stenosis discharged after transcatheter aortic valve implantation (TAVI).

Inclusion criteria:

Patients with severe aortic stenosis undergoing TAVI.

Admission prior to TAVI for HF with diabetes mellitus, LVEF ≤40% or GFR 25-75 ml/min.

Exclusion criteria:

Allergy, intolerance or contraindication for dapagliflozin.

Concomitant treatment with iSGTL-2 or sulfonylureas.

GFR< 25ml/min/1.73 m²

SBP < 100 mmHg or DBP < 50 mmHg

Recurrent urinary tract infections (≥2 in the last year)

Concomitant pathology that limits life expectancy to <1 year

Study of the electrocardiograms prior to the activation of the infarction code.

Inclusion criteria

-Adults

-Chest pain or symptoms suggestive of myocardial ischemia

-EST at point J on the electrocardiogram  12-lead prior  to the activation of the heart attack code  in two adjacent branches ≥ 0.1 mV and in V2 and V3 ≥0.2 mV

Exclusion criteria

-Complete branch block.

-Patients with a troponin curve of myocardial necrosis will be excluded, even if they do not present significant stenosis of the epicardial coronary artery.

-ITS T ≤ 0.1 mV with pathological Q wave suggestive of previous chronic infarction.

Implementation of a decision support system and its effect on the optimization of lipid-lowering therapies in patients with acute coronary syndrome.

Inclusion criteria

• Age ≥18 to <80 years
• Provide written informed consent
• Present to a study center with ACS without prior treatment with LLT, in monotherapy or in combination.
• Willing to take lipid-lowering treatments for secondary prevention of cardiovascular diseases.

Exclusion criteria

• You cannot or do not want to use lipid-lowering treatments other than statins for the care of ACS.
• Written informed consent cannot be provided
• Measurement of LDL-C < 1,8 mmol/L on admission.