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

NCT04475094 | Unknown DMC

• 1 other identifier: 19-080
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

Myocardial Blood Flow

Outcome Measures

Primary Outcomes (3)

• Change in SAQ-7 Angina Frequency

  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

  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

  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

Study Arms (1)

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; Behavioral: Seattle Angina Questionnaire-7; Behavioral: Rose Dyspnea Scale

Interventions

Rubidium-82 DRUG

Consented subjects will undergo a rest/regadenoson stress myocardial perfusion PET study.

Also known as: Myocardial Perfusion PET

COHORT

Seattle Angina Questionnaire-7 BEHAVIORAL

Consented subjects will complete a SAQ-7.

COHORT

Rose Dyspnea Scale BEHAVIORAL

Consented subjects will complete a RDS.

COHORT

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• The index clinically-indicated rest/regadenoson stress myocardial perfusion PET study shows at least one reversible perfusion defect; and
• The MBFR measurement meets quality control criteria for accuracy; and
• 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
• 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.

You may not qualify if:

• EF \<40%
• Significant aortic stenosis/regurgitation
• Significant Mitral stenosis/regurgitation)
• Prior CABG
• 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)

Sponsors & Collaborators

• Cardiovascular Imaging Technologies: lead

Study Sites (1)

Saint Luke's Hospital Imaging Center

Kansas City, Missouri, 64111, United States

RECRUITING

Related Publications (30)

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Related Links

• Reference #30

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Rubidium-82

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Krishna Patel, MD

CONTACT

216-776-2196; kpatel@saint-lukes.org

Staci Courter, MA

CONTACT

816-531-2842; scourter@cvit.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 17, 2020
• Study Start: December 23, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: July 17, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)