Ischemic Heart DiseasePETREVASCNCT05018247

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

A study testing Revascularization by Coronary Artery Bypass Graft or Percutaneous Coronary Intervention in people with Ischemic Heart Disease, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ischemic Heart Disease
What is being tested?: Revascularization by Coronary Artery Bypass Graft or Percutaneous Coronary Intervention
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited States
Study dates: 4 May 2021to 19 May 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Gramercy Cardiac Diagnostic Services
New York, New York, 10001

Other trials in United States

About this study

Official title: A Prospective, Randomized Trial of Early Revascularization in Stable Ischemic Heart Disease Guided by Positron Emission Tomography of Artery Specific Integrated Comprehensive Quantitative Myocardial Perfusion

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.

Read the detailed description

The initial Positron Emission Tomography (PET) scan will be performed as part of clinical practice. If the patient is a potential candidate for the study, the patient will be screened for inclusion and exclusion criteria. After being informed about the study potential risks, all patients giving written informed consent will be randomized into one of two groups: Urgent revascularization combined with Optimal Medical Treatment (OMT) or OMT 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. Some crossover may occur with the two groups. The OMT without urgent revascularization patients will remain in that group, if clinically stable, up to three months. 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.

Conditions: Ischemic Heart Disease
Being tested: Revascularization by Coronary Artery Bypass Graft or Percutaneous Coronary Intervention
Keywords: Positron Emission Tomography, PET scan
Medical subject headings: Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Revascularization by Coronary Artery Bypass Graft or Percutaneous Coronary InterventionProcedure or surgery
Urgent revascularization via CABG or PCI combined with Optimal Medical Treatment

Study groups in NCT05018247
Study group	Role	What they receive
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. Receives: 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. Receives: Procedure: Revascularization by Coronary Artery Bypass Graft or Percutaneous Coronary Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Baseline and Day 105+20

Secondary outcomes (14)

Change in % of LV with CFCblue.
Change in % in Left Ventricle with Coronary Flow Capacity blue.
Measured: Baseline and Day 105 +20 and Day 365+30
Change in % of LV with CFCgreen.
Change in % of Left Ventricle with Coronary Flow Capacity green.
Measured: Baseline and Day 105 +20 and Day 365+30
Change in CFC histogram distribution.
Change in Coronary Flow Capacity histogram distribution.
Measured: Baseline and Day 105 +20 and Day 365+30
Change in minimum quadrant average CFR.
Change in minimum quadrant average Coronary Flow Reserve.
Measured: Baseline and Day 105 +20 and Day 365+30
Change in minimum quadrant average stress ml/min/g.
Minimum quadrant average stress changes during PET.
Measured: Baseline and Day 105 +20 and Day 365+30
Change in minimum stress relative quadrant average.
Change in relative minimum uptake on stress images.
Measured: Baseline and Day 105 +20 and Day 365+30
Change in global CFR.
Change in global Coronary Flow Reserve.
Measured: Baseline and Day 105 +20 and Day 365+30
Change in specific iso-contour defect size & its average CFR.
Change in specific iso-contour defect size \& its average Coronary Flow Reserve.
Measured: Baseline and Day 105 +20 and Day 365+30
Change in DEFECT stress ml/min/g.
Change of absolute flow in ml/min/g in the defect during stress.
Measured: Baseline and Day 105 +20 and Day 365+30
Change in DEFECT relative stress.
Change in size and severity of stress induced perfusion defects during stress.
Measured: Baseline and Day 105 +20 and Day 365+30
Changes in an additional 120 PET flow fields.
Changes in 120 PET flow fields derived in the CORE lab comparing Rentrop PETs with reprocessed PETs at University of Texas Health Science Center Houston
Measured: Baseline and Day 105 +20 and Day 365+30
Rate of adverse events
Rate of major adverse cardiovascular events (defined as death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest).
Measured: Baseline and Day 105 +20 and Day 365+30
Rate of safety events.
Rate of safety events during the course of the trial such as death or adverse effects.
Measured: Baseline and Day 105 +20 and Day 365+30
Rate of procedure-related adverse events
Rate of procedure-related adverse events such as death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest.
Measured: Baseline and Day 105 +20 and Day 365+30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 May 202119 May 2022

First posted24 Aug 2021
Study start4 May 2021
Primary completion19 May 2022
Study completion19 May 2022

Why it stopped: Terminated prematurely due to closure of the PET imaging facility

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: 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.
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05018247
Sponsor's protocol ID: 20211835
Acronym: PETREVASC
Status last verified: Oct 2023
First submitted: 10 Aug 2021
Last updated: 18 Oct 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ischemic Heart Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized Trial of Early Revascularization in Stable Ischemic Heart Disease Guided by Positron Emission Tomography of Artery Specific Integrated Comprehensive Quantitative Myocardial Perfusion
ClinicalTrials.gov ID: NCT05018247
Acronym / sponsor ID: PETREVASC / 20211835
Conditions: Ischemic Heart Disease
Keywords: Positron Emission Tomography, PET scan
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminated prematurely due to closure of the PET imaging facility
Enrolment: 14 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Study start: 4 May 2021 (actual)
Primary completion: 19 May 2022 (actual)
Study completion: 19 May 2022 (actual)
First posted: 24 Aug 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Urgent revascularization with Optimal Medical Therapy	Active comparator	Procedure: Revascularization by Coronary Artery Bypass Graft or Percutaneous Coronary InterventionRevascularization 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.
Optimal Medical Treatment with delayed revascularization	Other	Procedure: Revascularization by Coronary Artery Bypass Graft or Percutaneous Coronary InterventionOMT 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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:
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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Revascularization by Coronary Artery Bypass Graft or Percutaneous Coronary InterventionUrgent revascularization via CABG or PCI combined with Optimal Medical Treatment	Procedure or surgery	Optimal Medical Treatment with delayed revascularization, Urgent revascularization with Optimal Medical Therapy

Primary outcome

Change from baseline in the % of left ventricle (LV) with Coronary Flow Capacity (CFC)blue.
Time frame: Baseline and Day 105+20
CFCblue is defined as a dipyridamole induced stress flow ≤ 0.83 ml/min/g of myocardium and a CFR ≤ 1.27.
Change from baseline in the % of left ventricle (LV) with Coronary Flow Capacity (CFC)green.
Time frame: Baseline and Day 105+20
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.

14 secondary outcomes

Change in % of LV with CFCblue.
Time frame: Baseline and Day 105 +20 and Day 365+30
Change in % of LV with CFCgreen.
Time frame: Baseline and Day 105 +20 and Day 365+30
Change in CFC histogram distribution.
Time frame: Baseline and Day 105 +20 and Day 365+30
Change in minimum quadrant average CFR.
Time frame: Baseline and Day 105 +20 and Day 365+30
Change in minimum quadrant average stress ml/min/g.
Time frame: Baseline and Day 105 +20 and Day 365+30
Change in minimum stress relative quadrant average.
Time frame: Baseline and Day 105 +20 and Day 365+30
Change in global CFR.
Time frame: Baseline and Day 105 +20 and Day 365+30
Change in specific iso-contour defect size & its average CFR.
Time frame: Baseline and Day 105 +20 and Day 365+30
Change in DEFECT stress ml/min/g.
Time frame: Baseline and Day 105 +20 and Day 365+30
Change in DEFECT relative stress.
Time frame: Baseline and Day 105 +20 and Day 365+30
Changes in an additional 120 PET flow fields.
Time frame: Baseline and Day 105 +20 and Day 365+30
Rate of adverse events
Time frame: Baseline and Day 105 +20 and Day 365+30
Rate of safety events.
Time frame: Baseline and Day 105 +20 and Day 365+30
Rate of procedure-related adverse events
Time frame: Baseline and Day 105 +20 and Day 365+30

Results and safety

The study was stopped early (reason given: Terminated prematurely due to closure of the PET imaging facility). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
Individual participant dataSharing planned: No

Related trials for Ischemic Heart Disease

Recruiting
Reducing Slow/No-Reflow With Prophylactic High-Dose Intracoronary Adenosine Protocol in ST-Elevation Myocardial Infarction The REFLOW AMI Trial
ST-Elevation Myocardial Infarction (STEMI)
Active, not recruiting
Insulin Resistance and Coronary Microvascular Dysfunction in Patients With Myocardial Ischemia and Non-obstructive Coronary Artery Disease
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Not yet recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

K. Lance Gould, MD principal investigator

UT Health Science Center Houston

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Terminated prematurely due to closure of the PET imaging facility). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in the % of left ventricle (LV) with Coronary Flow Capacity (CFC)blue. (time frame: Baseline and Day 105+20). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05018247.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.