EXPLORE. Multi-center, randomized trial to study the impact of percutaneous coronary intervention on left ventricular function in patients with a non-infarct related chronic total occlusion after ST-elevation myocardial infarction: PCI vs. conservative approach in CTO patients after STEMI.

Recruiting

Conditions: 1. ST-elevation myocardial infarction (STEMI)
 NLD: ST-elevatie myocard infarct (STEMI), percutane coronaire interventie, chronische totale occlusie, linker ventrikel functie.
 3. Chronic total occlusion
 4. left ventricular function
 2. percutaneous coronary intervention

Registration Number: NL-OMON24093

Lead Sponsor: Investigator initiated studyAcademic Medical Center ¨C University of AmsterdamDepartment of cardiologyThe Netherlands Principal investigators:R.J. van der Schaaf, MDR.J. de Winter, MD, PhDJ.P. Henriques, MD, PhD

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 300

Inclusion Criteria

Patients after successful primary PCI for STEMI are screened for entry into this trial. A primary PCI is ¡®successful¡¯ when the residual stenosis of the culprit lesion < 50% and the TIMI flow ¡Ý 2.

Exclusion Criteria

1. Older than 80 years of age;

2. Persistent or permanent atrial fibrillation;

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measured by cardiac MRI at four months:<br /><br>1. Left ventricular ejection fraction;<br /><br>2. Left ventricular end-diastolic volume. <br>

Secondary Outcome Measures

Name	Time	Method
1. Left ventricular end-systolic volume measured by MRI at four months;<br /><br>2. Left ventricular remodeling parameters, left ventricular mass, and infarct size measured by MRI at four months;<br /> <br>3. Angiographic analysis of the treated CTO at one year (in patients with PCI of the CTO);<br /><br>4. Functional class according to the NYHA-Classification at 30 days, four months and one year;<br /><br>5. Major Adverse Cardiac Event, defined as cardiac death, myocardial infarction, or coronary bypass grafting after four months and one, two, three, four and five years;<br /><br>6. NT-proBNP at four months and at one year (relative to baseline);<br /><br>7. Heart rate-adjusted QT duration measured by resting electrocardiography at four months and one year (relative to baseline).<br>