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
- Conditions
- chronic total coronary occlusion10011082
- Registration Number
- NL-OMON49007
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 82
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 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.
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of the REVISE-CTO study is to determine whether in CTO<br /><br>patients, selected with a ischemic threshold, PCI of the CTO results in a<br /><br>greater reduction of the ischemic burden assessed with exercise myocardial<br /><br>perfusion SPECT from baseline to 6 months follow-up compared to a control group<br /><br>(OMT only). </p><br>
- Secondary Outcome Measures
Name Time Method