NCT03756870 Revascularization Versus Optimal Medical Therapy of Chronic Total Coronary Occlusions on Left Ventricular Ischemia Reduction
| NCT ID | NCT03756870 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Condition | Chronic Total Occlusion of Coronary Artery |
| Study Type | INTERVENTIONAL |
| Enrollment | 82 participants |
| Start Date | 2019-07-01 |
| Primary Completion | 2024-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 82 participants in total. It began in 2019-07-01 with a primary completion date of 2024-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, 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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03756870 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Total Occlusion of Coronary Artery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03756870 currently recruiting?
Yes, NCT03756870 is actively recruiting participants. Contact the research team at j.p.henriques@amc.uva.nl for enrollment information.
Where is the NCT03756870 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT03756870 clinical trial?
NCT03756870 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The trial plans to enroll 82 participants.