chronic total coronary occlusion chronic total occlusion
Conditions
Interventions
All patients will receive OMT, which focus on antianginal therapy, aiming for
at least two antianginal medications, adequate lipid-lowering therapy,
antiplatelet therapy and blood pressure lowering
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion 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
Exclusion criteria
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] 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the REVISE-CTO study is to determine whether in CTO patients, selected with a ischemic threshold, PCI of the CTO results in a greater reduction of the ischemic burden assessed with exercise myocardial perfusion SPECT from baseline to 6 months follow-up compared to a control group (OMT only). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives are: To assess the effect of PCI of the CTO compared to the control group on: 1) Functional outcome: (angina) symptoms, quality of life, cardio-pulmonary exercise capacity. 2) Left ventricular function: global function, segmental wall thickening and infarct size. 3) Ventricular repolarization ECG markers on rest and exercise ECG. Objectives from the collateral study performed in patients undergoing PCI of the CTO (n=41). To assess the influence of collaterals on: 4) Myocardial ischemia at baseline and follow-up assessed with exercise myocardial perfusion SPECT and compare the parameters in the CTO with the remote area. 5) Functional outcome, global and regional left ventricular function and infarct size Clinical objectives from the registry and randomized trial: 7) All outcomes will be stratified for gender and the prospective registry data will be used to evaluate the different CTO treatment strategies and outcomes in women compared to men 8) Safety endpoints and major clinical cardiac events will be registered and compared between treatment strategies | — |
Countries
Netherlands
Contacts
Public ContactM. Gommers
Amsterdam UMC
Outcome results
None listed