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Compares treatment options for Chronic Total Occlusion of Coronary Artery
Official title Revascularization Versus Optimal Medical Therapy of Chronic Total Coronary Occlusions on Left Ventricular Ischemia Reduction
ClinicalTrials.gov ID: NCT03756870
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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;
See the full eligibility criteria
- 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 assigned by chance trial...
- \>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.
- 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] \ 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.
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.