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Revascularization Versus Optimal Medical Therapy of Chronic Total Coronary Occlusions on Left Ventricular Ischemia Reduction (REVISE-CTO)

Primary Purpose

Chronic Total Occlusion of Coronary Artery

Status

Recruiting

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Percutaneous coronary intervention (PCI)

About this trial

This is an interventional treatment trial for Chronic Total Occlusion of Coronary Artery focused on measuring Chronic total coronary occlusion, Percutaneous coronary intervention, Optimal medical therapy, Myocardial ischemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion 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 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.
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.

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.

Sites / Locations

Amsterdam UMC, location AMCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CTO PCI

OMT

Arm Description

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

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

Outcomes

Primary Outcome Measures

Ischemia

Ischemic burden assessed with exercise myocardial perfusion SPECT-CT from baseline to 6 months follow-up.

Secondary Outcome Measures

Change in angina status assessed with the Seattle Angina Questionnaire.

5 Seattle Angina Questionnaire subscales (0-100), higher scores indicating better angina status.

Quality of life assessed with the Minnesota Living with Heart Failure Questionnaire (MLHFQ)

MLHFQ scale (0-105), lower scores indicating better quality of life.

The left ventricular ejection fraction assessed with cardiac magnetic resonance imaging

Full Information

NCT ID

NCT03756870

First Posted

November 26, 2018

Last Updated

July 19, 2023

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT03756870

Brief Title

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

Acronym

REVISE-CTO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2019 (Actual)

Primary Completion Date

January 1, 2024 (Anticipated)

Study Completion Date

January 1, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Total Occlusion of Coronary Artery

Keywords

Chronic total coronary occlusion, Percutaneous coronary intervention, Optimal medical therapy, Myocardial ischemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

1:1 parallel design

Masking

None (Open Label)

Allocation

Randomized

Enrollment

82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CTO PCI

Arm Type

Experimental

Arm Description

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

Arm Title

OMT

Arm Type

No Intervention

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Percutaneous coronary intervention (PCI)

Intervention Description

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

Primary Outcome Measure Information:

Title

Ischemia

Description

Ischemic burden assessed with exercise myocardial perfusion SPECT-CT from baseline to 6 months follow-up.

Time Frame

6 months follow-up

Secondary Outcome Measure Information:

Title

Change in angina status assessed with the Seattle Angina Questionnaire.

Description

5 Seattle Angina Questionnaire subscales (0-100), higher scores indicating better angina status.

Time Frame

6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years

Title

Quality of life assessed with the Minnesota Living with Heart Failure Questionnaire (MLHFQ)

Description

MLHFQ scale (0-105), lower scores indicating better quality of life.

Time Frame

6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years

Title

The left ventricular ejection fraction assessed with cardiac magnetic resonance imaging

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion 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 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. 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. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

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

Phone

+31205666405

j.p.henriques@amc.uva.nl

First Name & Middle Initial & Last Name or Official Title & Degree

Ms. A. van Veelen, MD

Phone

+31205666405

a.vanveelen@amc.uva.nl

Facility Information:

Facility Name

Amsterdam UMC, location AMC

City

Amsterdam

ZIP/Postal Code

1105AZ

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anna van Veelen, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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