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

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Nov 27, 2018

Keywords

ClinConnect Summary

This clinical trial is studying whether a procedure called percutaneous coronary intervention (PCI) for chronic total occlusions (CTOs) in the coronary arteries can reduce heart-related issues like ischemia, which is when the heart doesn't get enough blood. The researchers want to see if patients who undergo this procedure experience a greater reduction in ischemia compared to those who receive only optimal medical therapy, such as medications. They will measure the heart's blood flow and function through special imaging tests before and six months after the treatment.

To participate, you need to be between 65 and 74 years old and have a specific type of blockage in your coronary artery that has been present for at least three months. You must also be experiencing symptoms that indicate the need for PCI. If you agree to take part, you will receive either the PCI treatment or the medical therapy and will be asked to undergo follow-up tests to monitor your heart's condition. This trial aims to improve our understanding of how effective PCI is for patients with CTOs, especially regarding their overall heart health and quality of life.

Gender

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Eligibility criteria

• Inclusion Criteria:
• 1. A chronic total occlusion is present and target lesion. A CTO is required to meet the following characteristics:
• • 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.
• • 2. Patient has a clinical indication to perform CTO PCI.
• • 3. A SPECT is performed at baseline to assess ischemia and a cardiac magnetic resonance imaging (CMR) scan to assess viability, as part of routine patient care. Patients are deemed eligible for the randomized trial when they meet the ischemic threshold in the CTO territory.
• The ischemic threshold is defined as:
• • \>12.5% of ischemia;
• • With \<50% transmural extent of infarction.
• • 4. Subject agrees to undergo follow-up SPECT-CT at 6 months after initial inclusion
• • 5. Subject is able to verbally confirm understanding and he/she provides written informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee.
• Exclusion Criteria:
• • 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;
• • Unable to exert, i.e. due to physical disability;
• • Any contraindication for SPECT or CMR, i.e. cerebrovascular clips, claustrophobia;
• • Known renal insufficiency (estimated Glomerular Filtration Rate \[eGFR\] \<60 mL/min/1.73m2 or serum creatinine level of \>2.5 mg/dL or subject on dialysis);
• • Hypersensitivity or allergy to contrast with inability to properly pre-hydrate;
• • Presence of a comorbid condition with a life expectancy of less than one year;
• • Participation in another trial;
• • Subject is belonging to a vulnerable population (per investigator's judgment, e.g., subordinate hospital staff) or is unable to read or write.