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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05349084
• Other study ID #: 201904112
• Status: Completed
• Phase: N/A
• Start date: June 6, 2019
• Est. completion date: July 18, 2023

Study information

• Verified date: September 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Description:

This is a single cohort, technology assessment study. Thirty-five patients presenting with stable angina and a moderate pretest likelihood for CAD who are already scheduled to undergo invasive coronary angiography (ICA) for the clinical indication of angina will be recruited to undergo a cCTA examination with FFR followed immediately by regadenoson stress-rest PET on the same PET/CT scanner. Sensitivity, specificity, NPV, PPV of CTA-cFFR will be obtained using the reference standard of standard of care ICA with FFR for each epicardial coronary artery. Segmental stress PET MBF will be compared to presence or absence of a coronary artery stenosis ≥ 50% diameter on CCTA and ICA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 18, 2023
• Est. primary completion date: July 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 18-90 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Diagnostic Test:
• PET-cCTA-cFFR
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

Locations

Country	Name	City	State
United States	Washington University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1 - Day of Scan
Primary	Reduction in myocardial myocardial blood flow (MBF) on PET	Decreased MBF (mL/g/min) in regions of coronary stenosis = 50% diameter by CCTA.	Day 1 - Day of Scan