Early Revascularization in Stable Ischemic Heart Disease Using P.E.T. Imaging

NCT05018247 | Terminated DMC

• 1 other identifier: 20211835
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the impact of revascularization and Optimal Medical Treatment (OMT) on the extent of severely reduced coronary flow capacity in stable ischemic heart disease.

Conditions

Ischemic Heart Disease

Keywords

Positron Emission Tomography; PET scan

Outcome Measures

Primary Outcomes (2)

• Change from baseline in the % of left ventricle (LV) with Coronary Flow Capacity (CFC)blue.

  CFCblue is defined as a dipyridamole induced stress flow ≤ 0.83 ml/min/g of myocardium and a CFR ≤ 1.27.

  Baseline and Day 105+20

• Change from baseline in the % of left ventricle (LV) with Coronary Flow Capacity (CFC)green.

  CFCgreen is defined as a dipyridamole induced stress flow ≤1.09 and \>0.83 ml/min/g of myocardium and a CFR ≤1.60 and \>1.27.

  Baseline and Day 105+20

Secondary Outcomes (14)

• Change in % of LV with CFCblue.

  Baseline and Day 105 +20 and Day 365+30

• Change in % of LV with CFCgreen.

  Baseline and Day 105 +20 and Day 365+30

• Change in CFC histogram distribution.

  Baseline and Day 105 +20 and Day 365+30

• Change in minimum quadrant average CFR.

  Baseline and Day 105 +20 and Day 365+30

• Change in minimum quadrant average stress ml/min/g.

  Baseline and Day 105 +20 and Day 365+30

Study Arms (2)

Urgent revascularization with Optimal Medical Therapy

ACTIVE COMPARATOR

Revascularization will be performed via either Percutaneous Coronary Intervention or Coronary Artery Bypass Graft, and the selection of the specific procedure will be at the discretion of the patient and their physician(s). Patients will be followed for one year after randomization. Follow-up visits will occur at Baseline, Day 105, and Day 365. At each visit, a rest-stress PET assessment will be performed, and adverse events related to study procedures and cardiac disease will be captured.

Procedure: Revascularization by Coronary Artery Bypass Graft or Percutaneous Coronary Intervention

Optimal Medical Treatment with delayed revascularization

OTHER

OMT without revascularization for a minimum of approximately 105 days if clinically stable. At their first follow-up visit (Day 105±20), patients will be offered the option of continued medical treatment or elective revascularization consistent with informed patient preference and clinical judgement. Patients, in consultation with their physicians, may elect to undergo revascularization at any time thereafter and will be followed for one year after randomization. Follow-up visits will occur at Baseline, Day 105, and Day 365. At each visit, a rest-stress PET assessment will be performed, and adverse events related to study procedures and cardiac disease will be captured.

Procedure: Revascularization by Coronary Artery Bypass Graft or Percutaneous Coronary Intervention

Interventions

Revascularization by Coronary Artery Bypass Graft or Percutaneous Coronary Intervention PROCEDURE

Urgent revascularization via CABG or PCI combined with Optimal Medical Treatment

Optimal Medical Treatment with delayed revascularization; Urgent revascularization with Optimal Medical Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Stable ischemic heart disease as determined by an investigator.
• Areas of severely reduced CFC or relative stress images on the Rentrop diagnostic PET MPI consistent with clinical judgement as follows:
• PETs with a defect on rest relative images of ≤60% of max for ≤5% of LV (no large scar) plus: i. ≥2% of LV with CFCblue\* or ii. ≥10% of LV with CFCgreen\* plus at least one pixel with CFCblue\*
• \*CFCblue is defined as a dipyridamole induced stress flow ≤ 0.83 ml/min/g of myocardium and a CFR ≤ 1.27. CFCgreen is defined as a dipyridamole induced stress flow ≤1.09 and \>0.83 ml/min/g of myocardium and a CFR ≤1.60 and \>1.27.
• Willing to comply with the follow-up schedule of the trial.
• Subject must sign the informed consent in English or Spanish.

You may not qualify if:

• Any conditions that may compromise or prevent the necessary imaging requirements.
• Less than one-year life expectancy.
• Currently pregnant or planning to become pregnant during the course of the study.
• Any other issues that the Investigator believes may interfere with treatment or follow-up.
• Subjects who lack capacity to consent for themselves.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Gramercy Cardiac Diagnostic Services

New York, New York, 10001, United States

Location

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• K. Lance Gould, MD

  UT Health Science Center Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Study personnel and subjects will not be blinded. All core lab measurements, comparisons, and statistical analysis will be blinded to group assignment by blinded coding of PET images. Two volunteers who are not involved in the study in any way to create randomization envelopes with each arm. The study staff volunteers for randomization assignment will: Create a randomization list with two arms (52 per arm). Create 104 sequential envelopes which will contain a paper with the assignment based on the randomization list. The sequential randomization envelopes will be kept in the site PI's locked office thereby allowing for randomization immediately after consent is obtained. The randomization arm will be shared with the research team and the subject.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: After randomization, patients will receive urgent revascularization combined with Optimal Medical Treatment or Optimal Medical Treatment with delayed revascularization. Following the initial PET scan, randomization and treatment, each group will undergo a second PET scan at the 3-4 month mark and a third PET scan at the one year mark. At their first follow-up visit (3-4 month mark), patients in the OMT with delayed revascularization group will be offered the option of continued medical treatment or elective revascularization consistent with informed patient preference and clinical judgement. Patients, in consultation with their physicians, may elect to undergo revascularization at any time thereafter.

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 24, 2021
• Study Start: May 4, 2021
• Primary Completion: May 19, 2022
• Study Completion: May 19, 2022
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)