Recruiting

Coronary Artery Stenting

Sponsor:

Cardiovascular Imaging Technologies

Code:

NCT04475094

Conditions

Coronary Artery Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Rubidium-82

Seattle Angina Questionnaire-7

Rose Dyspnea Scale

Study Details

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

Study ID

NCT04475094

Start date

Dec 23, 2019

Status verified date

Jul, 2020

Completion date

Dec 31, 2021

Anticipated

Primary completion date

Dec 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

75 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Rubidium-82

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

Seattle Angina Questionnaire-7

Consented subjects will complete a SAQ-7.

Rose Dyspnea Scale

Consented subjects will complete a RDS.

Primary outcome measure

  • Change in SAQ-7 Angina Frequency [ Time Frame: 3-8 weeks ]
  • Change in MBFR [ Time Frame: 3-8 weeks ]
  • Extent of Epicaridal Stenoses [ Time Frame: 3-8 weeks ]

Central Contacts and Locations

Central contacts

Locations

Saint Luke's Hospital Imaging Center

Recruiting

Kansas City, Missouri, United States, 64111

Contacts

Timothy M Bateman, MD

816-531-2842tbateman@cvit.com

More Information

Sponsor

Cardiovascular Imaging Technologies

Last update posted

Jul 17, 2020

Last verified

Jul, 2020

Keywords

  • Myocardial Blood Flow

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cardiovascular Imaging Technologies on 2020-07-17.