Revascularization Versus Optimal Medical Therapy of Chronic Total Coronary Occlusions on Left Ventricular Ischemia Reduction

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

About this trial

Rationale: Randomized trials could not yet establish favourable outcomes of CTO PCI on hard endpoints such as ejection fraction or mortality, when compared to optimal medical therapy. However, patients after CTO PCI appeared to be more frequently free of angina complaints, but the aetiology behind this is not fully understood. The investigators hypothesize that PCI of the CTO in patients preselected with an ischemic threshold (\>12.5%) on cardiac imaging leads to a reduction of the ischemic burden and therefore an increased benefit on functional outcomes.

Objective: Primary objective is to determine whether PCI of the CTO will yield a higher reduction of ischemia assessed by exercise myocardial perfusion SPECT-CT from baseline to 6-month follow-up compared to a control group. Secondary objectives are 1) to evaluate the effect of PCI of the CTO on improvement in functional status, infarct size and left ventricular function from baseline to follow-up compared to the control group; 2) to study the association between ischemia reduction and functional outcome and left ventricular function; 3) to assess the influence of the collateral flow index on the ischemic burden (reduction), functional status, infarct size and left ventricular (contractile) function (hibernation).

Study design: open multicentre randomized trial

Study population: 82 patients eligible for CTO PCI

Intervention: CTO PCI

Primary endpoint: ischemic burden assessed with exercise myocardial perfusion SPECT-CT from baseline to 6 months follow-up.

Eligibility criteria

Qualifiers

A 100% luminal narrowing of the coronary artery without antegrade flow, i.e. Thrombolysis in Myocardial Infarction flow grade 0 or 1;

Older than 3 months, established with previous PCI or with angiographic characteristics;

Amenable to percutaneous revascularization.

Patient has a clinical indication to perform CTO PCI.

Disqualifiers

Subject is younger than 18 years of age;

Persistent or permanent atrial fibrillation;

Presence of a non-MRI compatible cardiac device, i.e. pacemaker or implantable cardioverter defibrillator;

Body weight > 250 kg;

Trial design

Treatments tested in this trial

  • Percutaneous coronary intervention (PCI)

Treatment groups

82 Participants
are divided into 2 treatment groups