Revascularization Versus Optimal Medical Therapy of Chronic Total Coronary Occlusions on Left Ventricular Ischemia Reduction

NCT ID: NCT03756870

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2030-01-01

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.

Conditions

Chronic Total Occlusion of Coronary Artery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CTO PCI

Patients will receive optimal medical therapy, with percutaneous coronary intervention of the chronic total occlusion.

Group Type: EXPERIMENTAL

Percutaneous coronary intervention (PCI)

Intervention Type: PROCEDURE

A percutaneous coronary intervention of the chronic total occlusion with a drug-eluting stent.

OMT

Patients will receive optimal medical therapy, without percutaneous coronary intervention of the chronic total occlusion.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Percutaneous coronary intervention (PCI)

A percutaneous coronary intervention of the chronic total occlusion with a drug-eluting stent.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: lead

Responsible Party

J.P.S Henriques

Principal Investigator, Head of Catheterization Laboratory

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Amsterdam UMC, location AMC

Amsterdam, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Prof. J.P.S. Henriques, MD PhD

Role: CONTACT

j.p.henriques@amc.uva.nl

+31205666405

Ms. A. van Veelen, MD

Role: CONTACT

a.vanveelen@amc.uva.nl

+31205666405

Facility Contacts

Anna van Veelen, MD

Role: primary

Other Identifiers

REVISE-CTO

Identifier Type: -

Identifier Source: org_study_id