Cardiovascular-kidney-metabolic (CKM)-Guided Therapy for Patients After Acute Coronary Syndrome

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZuyderland Medisch Centrum

About this trial

Patients with a history of myocardial infarction are at significantly increased risk of recurrent cardiovascular events. Despite established clinical guidelines, secondary preventive care is often initiated too late, inadequate in intensity or incomplete in application. As a result, important opportunities to prevent serious outcomes are missed.

The aim of this project is to investigate whether rapid, guideline-based treatment following myocardial infarction leads to improved patient outcomes. The study protocol is based on current clinical guidelines and targets key domains including diabetes, hypertension, and hypercholesterolemia. Outcomes of patients treated according to the study protocol will be compared to those receiving standard care. Primary endpoints include major adverse cardiac- and cerebrovascular events within a 24-month follow-up period.

The investigators hypothesize that rapid, guideline-based intervention will result in improved risk factor management, leading to a reduction in cardiovascular events and mortality. For patients, this may translate into improved health, quality of life and life expectancy. This project aims to deliver a practical protocol for effective secondary prevention in clinical practice, which is expected to reduce healthcare utilization in the long term. With this initiative, the investigators seek to take a significant step toward improving post-myocardial infarction care and contributing to sustainable cardiovascular healthcare.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years

Hospitalised with acute coronary syndrome

Underwent percutaneous coronary intervention

Disqualifiers

Acute coronary syndrome secondary to other diseases

Life expectancy < 1 year based on the clinician's expertise

Trial population

The study population consists of patients, hospitalised in Zuyderland, who underwent a percutaneous coronary intervention due to an acute coronary syndrome (unstable angina (UA), ST-elevation myocardial infarction (STEMI), or non ST-elevation myocardial infarction (non-STEMI)).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Rapid ESC-guideline based secondary prevention following myocardial infaction

    Drug

    In the intervention group, patients will be treated according to a rapid ESC-guideline-based protocol. This approach will target: 1\. Optimal pharmacological treatment, including: * Lipid-lowering * Antihypertensive * Diabetic, such sodium-glucose co-transporter 2 inhibitors (SGLT-2 inhibitors) * Glucagon-like peptide-1 agonists (GLP-1 agonists)

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

MACCE within 2 years after the ACS and PCI

The occurrence of major adverse cardiac- and cerebrovascular events (MACCE) defined as the composite of all cause death, myocardial infarction, (ischemic or hemorrhagic) CVA, and ischemia-driven revascularization at 24 months.

Time frame
From enrollment to end of 2 year follow-up

Secondary outcomes

1

30 days endpoints checklist

Prevelance of the following endpoints with 30 days after discharge: * Death due to any cause * Cardiovascular mortality * Reacurent acute coronary syndrom * Ischemia-driven revascularization * Ischemic CVA * Haemorrhagic CVA * Uplanned cardiovascular hospital readmission * New onset of diabetes mellitus type 2 * New onset of peripheral arterial disease * Sustained decline of eGFR of 50% for more than 3 months based on eGFR lab value Measures will be defined as either present or absent and collected via medical record.

Time frame
From discharge till 30 days after discharge
2

Quality of life survey at 30 days

Patients recieve a quality of life survey at 30 days after discharge. This is done with a SF-36 questionnaire

Time frame
30 days after discharge
3

1 year endpoints checklist

Prevelance of the following endpoints 1 year after discharge: * Death due to any cause * Cardiovascular mortality * Reacurent acute coronary syndrom * Ischemia-driven revascularization * Ischemic CVA * Haemorrhagic CVA * Uplanned cardiovascular hospital readmission * New onset of diabetes mellitus type 2 * New onset of peripheral arterial disease * Sustained decline of eGFR of 50% for more than 3 months Measures will be defined as either present or absent and collected via medical record.

Time frame
Between 30 days and 1 year after discharge
4

Quality of life survey at 1year

Patients recieve a quality of life survey at 1year after discharge. This is done with a SF-36 questionnaire

Time frame
1 year after discharge

Other outcomes

Sponsors and contacts

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