PET MYOCARDIAL Blood Flow Comparison to Coronary CTA and CT-FFR

NCT05349084 | Completed Results FDA Device

• 1 other identifier: 201904112
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The broad, long-term objective of this pilot study is to develop an optimal, clinically usable, non-invasive evaluation of Coronary Artery Disease (CAD) in the setting of stable angina which provides both anatomic and functional information. Patients already scheduled to undergo Invasive coronary catheterization (ICA) for the clinical indication of angina will be recruited to under go stress-rest Positron Emission Tomography-Coronary CT Angiography-Fractional Flow Reserve (PET-cCTA-cFFR)

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

• Number of Flow-limiting Coronary Artery Stenosis on CT

  CT presence of flow limiting stenosis (≤ 0.8) as determined by CT-FFR in comparison to invasive coronary artery (ICA) FFR. CT-FFR was determined in the following myocardial segments: left anterior descending (LAD), left circumflex (LCx), and right coronary artery (RCA). The number of coronary artery stenoses as determined by CT (CT-FFR ≤ 0.8) was measured.

  Day 1 - Day of Scan

• Association Between Stress Myocardial Blood Flow (MBF) on PET and Coronary Artery Stenosis on CCTA

  Association between N-13 Ammonia PET MBF (mL/g/min) during stress and presence or absence of coronary artery stenosis ≥ 50% diameter on CCTA as determined by measurement in each epicardial coronary artery. The MBF values during stress were categorized as normal or abnormal. Normal MBF is defined as \>1.8 mL/g/min. MBF and percent diameter stenosis were determined in the following myocardial segments: left anterior descending (LAD), left circumflex (LCx), and right coronary artery (RCA).

  Day 1 - Day of Scan

Secondary Outcomes (6)

• Correlation of Myocardial Blood Flow (MBF) by PET to Fractional Flow Reserve (FFR) by CT.

  Day 1 - Day of Scan

• CT-Fractional Flow Reserve (CT-FFR) Global

  Day 1 - Day of Scan

• Instant Wave Free Ratio (iFR)

  Day of invasive coronary catheterization - within 2 weeks of imaging

• N-13 Ammonia PET Global Myocardial Blood Flow (MBF) Stress

  Day 1 - Day of Scan

• N-13 Ammonia PET Global Myocardial Blood Flow (MBF) Rest

  Day 1 - Day of Scan

Study Arms (1)

PET-cCTA-cFFR

OTHER

patients presenting with stable angina and a moderate pretest likelihood for CAD who are already scheduled to undergo ICA for the clinical indication of angina will be recruited to undergo PET-cCTA-cFFR

Diagnostic Test: PET-cCTA-cFFR

Interventions

PET-cCTA-cFFR DIAGNOSTIC_TEST

patients presenting with stable angina and a moderate pretest likelihood for CAD who are already scheduled to undergo ICA for the clinical indication of angina will be recruited to undergo PET-cCTA-cFFR

PET-cCTA-cFFR

Eligibility Criteria

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

You may qualify if:

• years of age, of either sex
• Patients presenting with stable angina and a moderate pretest likelihood for CAD and scheduled to undergo ICA for the clinical indication of angina. Subjects will undergo this study within 45 days prior to the cardiac catheterization. This study can also be performed 45 days after the cardiac catheterization if the patient had no interventions.

You may not qualify if:

• Prior history of stenting, coronary artery bypass graft surgery, or myocardial infarction, unstable angina, atrial fibrillation, second or third degree atrioventricular block, class IV heart failure
• Iodine allergy
• Renal dysfunction (creatinine above normal laboratory limits)
• Symptomatic asthma
• Women who are pregnant or breast-feeding

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

1. Small number of patient subjects. 2. Small number of patients with coronary artery stenoses ≥50% diameter.

Results Point of Contact

• Title: Dr. Pamela K. Woodard
• Organization: Washington University School of Medicine

woodardp@wustl.edu

314-362-7100

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 27, 2022
• Study Start: June 6, 2019
• Primary Completion: July 18, 2023
• Study Completion: July 18, 2023
• Last Updated: September 26, 2024
• Results First Posted: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 3 months and ending 10 years following article publication.
• Access Criteria: Proposals should be directly submitted to woodardp@wustl.edu.

Locations

US (1)