Percutaneous coronary intervention versus conservative treatment in patients with stable angina pectoris (EUREGIO AP study): Can magnetic resonance perfusion imaging improve the triage of patients with stable angina?

Completed

• Conditions: Atherosclerosis; 10011082

• Registration Number: NL-OMON34978
• Lead Sponsor: Cardiologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 400

Inclusion Criteria

All patients with stable angina pectoris and >=70% stenosis in at least one epicardial coronary artery (proximal or mid segment) can be included. Stable angina pectoris is defined as Canadian Cardiovascular Society [CCS] class I-III or medically stabilized class IV angina. Patients must be able to give informed consent.

Exclusion Criteria

General:
- Age < 18 years.
- Pregnancy.
- Significant systemic hypertension (BP > 200/100mmHg) unresponsive to medical therapy.;Other cardiac pathology:
- Atrial fibrillation.
- Cardiogenic shock.
- Previous myocardial infarction, defined as: (UNL = upper normal limit)
a) New Q wave at any time.
b) Spontaneous, total CK/CK-MB >= 1.5 x UNL or troponin >= 2 x UNL.
- Congestive heart failure NYHA class >=III.
- Previous CABG or PCI.
- Unstable angina pectoris (persistent CCS class IV despite medical treatment).
- Left main (>= 50%) or 3 vessel disease or markedly positive treadmill test during stage 1 of the Bruce protocol.
- Ejection fraction < 30 %
- Concomitant valvular disease likely to require surgery or affect prognosis during follow up.
- Congenital or primary cardiac muscle disease likely to affect prognosis during follow-up.
- Resuscitated out-of-hospital sudden death or symptomatic sustained or non-sustained ventricular tachycardia.

Contraindications to MR imaging:
- Noncompatible metallic implant (vascular clip, neurostimulator, cochlear implant).
- Pacemaker or ICD.
- Claustrophobia.
- Body weight >130 kg. ;Contraindication to MRI contrastagent (Gadolinium):
- Renal failure (estimated GFR <= 30 mL/min) or chronic kidney disease stage 4 & 5. ;Contraindication to adenosine side effects:
- AV-block (2nd or 3rd degree).
- Severe asthma.
- COPD Gold IV.;To exclude patients with chest pain from non-cardiac origin, CT-angiography or coronary angiography will be performed to confirm the presence of significant coronary artery disease (>=70% stenosis).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameters are a combined endpoint of time to adverse cardiac<br /><br>events defined as: all-cause mortality, myocardial infarction/acute coronary<br /><br>syndrome, hospitalization for unstable angina with negative biomarkers,<br /><br>coronary artery bypass grafting and coronary angioplasty. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary end points are quality of life (Canadian Cardiovascular Society<br /><br>angina class at follow-up); the usage of antianginal drugs, cost-effectiveness<br /><br>and the prognostic value of hs-cTNT. </p><br>