Status:
RECRUITING
Revascularization Versus Optimal Medical Therapy of Chronic Total Coronary Occlusions on Left Ventricular Ischemia Reduction
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Chronic Total Occlusion of Coronary Artery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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, patient...
Eligibility Criteria
Inclusion
- 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.
- Patient has a clinical indication to perform CTO PCI.
- 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.
- Subject agrees to undergo follow-up SPECT-CT at 6 months after initial inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2030
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT03756870
Start Date
July 1 2019
End Date
January 1 2030
Last Update
July 20 2023
Active Locations (1)
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1
Amsterdam UMC, location AMC
Amsterdam, Netherlands, 1105AZ