Comparing heart procedures and medication for blocked coronary arteries

REvascularization Versus Optimal Medical Therapy on Left Ventricular ISchemia Reduction: Exploring the Associations Between Ischemia, Functional Outcome and Collaterals in the Treatment of Chronic Total Occlusion Patients

This study is testing if a heart procedure called PCI can help people with completely blocked coronary arteries feel better and have improved heart function compared to just using medication.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 82 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Academic / other)
• Locations: 1 site (Amsterdam)
• Trial ID: NCT03756870 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of percutaneous coronary intervention (PCI) on patients with chronic total occlusion (CTO) of coronary arteries, comparing it to optimal medical therapy. The primary goal is to determine if PCI leads to a greater reduction in myocardial ischemia, as measured by exercise myocardial perfusion SPECT-CT, over a six-month period. Secondary objectives include assessing improvements in functional status, infarct size, and left ventricular function. Patients will be selected based on specific ischemic thresholds determined by cardiac imaging.

Who should consider this trial

Good fit: Ideal candidates are patients with chronic total occlusions of coronary arteries who meet specific ischemic thresholds and are clinically indicated for PCI.

Not a fit: Patients without significant ischemia or those who do not meet the criteria for chronic total occlusion may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into more effective treatment options for patients with chronic total coronary occlusions, potentially improving their quality of life.

How similar studies have performed: Previous studies have shown mixed results regarding the benefits of PCI for chronic total occlusions, indicating that this approach is still being explored.

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.

Where this trial is running

Amsterdam

• Amsterdam UMC, location AMC — Amsterdam, Netherlands (Recruiting)

Study contacts

• Study coordinator: Prof. J.P.S. Henriques, MD PhD

Conditions Chronic Total Occlusion of Coronary Artery; Chronic total coronary occlusion; Percutaneous coronary intervention; Optimal medical therapy; Myocardial ischemia