Impact of Coronary Artery Stenting on Quantitative Myocardial Blood Flow and Health Status

July 15, 2020 updated by: Timothy M. Bateman, MD, Cardiovascular Imaging Technologies
We propose to perform PET MPI studies in patients before and after stenting to evaluate changes (or lack thereof) in MBFR and how that is associated with changes (or lack thereof) in symptoms, functional status and quality of life. This will help to understand the role of MBFR in patient selection for coronary angiography and stenting.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Myocardial perfusion imaging (MPI) has a well-established role in diagnosis, risk stratification and prognostication in patients with suspected or known coronary artery disease (CAD)(1,2). As the current health-care landscape moves towards rewarding value, there is an increased urgency for determining the role of imaging tests in improving patient-centered outcomes (3-5). Traditionally, the cardiac imaging community has focused on studying "hard outcomes" such as cardiac morbidity and mortality, with relatively little attention on patient-centered health status outcomes (e.g. symptoms, function and quality of life).

While Single Photon Emission Computed Tomography (SPECT) has been a myocardial perfusion imaging (MPI) mainstay for decades, use of Positron Emission Tomography (PET) MPI has been increasing as it offers superior spatial resolution, lower radiation exposure, higher diagnostic accuracy, shorter acquisition times and quantification of myocardial blood flow reserve (MBFR) (6-9). MBFR integrates the hemodynamic effects of microvascular dysfunction, diffuse atherosclerotic disease and epicardial stenosis on myocardial tissue perfusion, and as such is more likely to correlate with patient's anginal symptoms, functional status and quality of life (10,11). MBFR measured by PET MPI has been shown to provide independent and incremental prognostic value for major adverse cardiac events beyond perfusion defect analysis, but has not been evaluated for its association with symptoms, function and quality of life (although in a post-hoc analysis of 171 patients with known CAD undergoing PET MPI enrolled in the ASPIRE study at our center, higher MBFR was significantly associated with lower anginal burden as measured by the Seattle Angina Questionnaire (SAQ; unpublished data, being presented at ASNC 2018)) (8,10,12-15). Among 329 patients, Taqueti et al demonstrated that patients with low global MBFR were less likely to require subsequent heart failure hospitalizations and cardiac deaths if treated with early revascularization with bypass surgery, but not percutaneous coronary intervention (PCI), as compared with medical management; however the low number of events and the small sample size were major limiting factors (10). More recently, among 12,594 patients undergoing PET MPI, we demonstrated that MBFR <1.8 may help identify patients with a survival benefit from early revascularization within 90 days of the index MPI test. (unpublished data, being presented at AHA 2018). In a sub-study of the PACIFIC study, Driessen et al showed strong correlation of change in MBFR post revascularization with change in FFR; providing further support for non-invasively measured MBFR as a potential measure to target intervention, similar to FFR, which needs invasive measurement on coronary angiography (16).

To further elucidate the mechanism of action by which MBFR could be used to target management for ischemic heart disease, we propose a study of serial PET MPI in 75 patients undergoing coronary stenting to evaluate the association of changes in MBFR with changes in patients' health status. About a quarter to half of stable CAD patients treated with PCI continue to have angina and poor quality of life after stenting (17-19) This may be because stenting is only directed at epicardial stenoses, while many patients have concomitant microvascular disease. While there has been some data where serial PET MPI studies have been used to look at changes in perfusion defect sizes and flows with anti-ischemic medications and statins (20-24) it is not known whether these changes are associated with improved outcomes. We propose to perform PET MPI studies in patients before and after stenting to evaluate changes (or lack thereof) in MBFR and how that is associated with changes (or lack thereof) in symptoms, functional status and quality of life. This will help to understand the role of MBFR in patient selection for coronary angiography and stenting.

Study Type

Observational

Enrollment (Anticipated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Saint Luke's Hospital Imaging Center
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Krishna Patel, MD
        • Sub-Investigator:
          • James Case, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients will have had a clinically-indicated PET revealing at least one reversible perfusion defect followed by a research-indicated cardiac PET study between 3 and 8 weeks post-successful coronary artery stenting.

Description

Inclusion Criteria:

  1. The index clinically-indicated rest/regadenoson stress myocardial perfusion PET study shows at least one reversible perfusion defect; and
  2. The MBFR measurement meets quality control criteria for accuracy; and
  3. The patient has completed a baseline SAQ-7 and RDS survey with a SAQ-7 Angina Frequency Score <100 (indicating the occurrence of at least some angina symptoms over the past 4 weeks); and
  4. The patient has undergone a successful coronary artery stenting within 60 days after the PET scan without a significant change in clinical condition between the time of baseline PET MPI test and PCI; and 5. The patient agrees to undergo a second PET scan 3-6 weeks after coronary artery stenting and to complete a second SAQ-7 and RDS survey.

Exclusion Criteria:

  1. EF <40%
  2. Significant aortic stenosis/regurgitation
  3. Significant Mitral stenosis/regurgitation)
  4. Prior CABG
  5. Poor quality base line PET study due one or more technical challenges (e.g. patient motion, imprecise registration of CT and emission data, flows that violate quality criteria, lack of flow augmentation suggestive of an A2A antagonist)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COHORT
All patients will have had a clinically-indicated PET revealing at least one reversible perfusion defect followed by a research-indicated cardiac PET study between 3 and 8 weeks post-successful coronary artery stenting.
Drug: Rubidium-82
Consented subjects will undergo a rest/regadenoson stress myocardial perfusion PET study.
Other Names:
  • Myocardial Perfusion PET
Behavioral: Seattle Angina Questionnaire-7
Consented subjects will complete a SAQ-7.
Behavioral: Rose Dyspnea Scale
Consented subjects will complete a RDS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in SAQ-7 Angina Frequency
Time Frame: 3-8 weeks
The primary study objective is to estimate the association of change from baseline in MBFR with SAQ-7 Angina Frequency scores, adjusting for baseline MBFR, baseline SAQ and other patient factors.
3-8 weeks
Change in MBFR
Time Frame: 3-8 weeks
Secondary objective is to estimate the association of change in MBFR with adjusted SAQ-7 Physical Limitation, Quality of Life and Summary scores and Rose Dyspnea Scores (RDS).
3-8 weeks
Extent of Epicaridal Stenoses
Time Frame: 3-8 weeks
Exploratory objectives include estimating the association of the extent of epicardial stenoses (vs. microvascular disease) at baseline with post-stent MBFR, SAQ-7 and RDS scores, adjusting for baseline.
3-8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiovascular Imaging Technologies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2019

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

July 15, 2020

First Submitted That Met QC Criteria

July 15, 2020

First Posted (Actual)

July 17, 2020

Study Record Updates

Last Update Posted (Actual)

July 17, 2020

Last Update Submitted That Met QC Criteria

July 15, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-080

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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