Quantification of Myocardial Blood Flow Using Dynamic PET/CTA Fused Imagery
Completed
Conditions studied: Coronary Artery Disease
In brief
This observational prospective clinical study is to develop software tools to fuse coronary anatomy data obtained from CT coronary angiography with dynamic PET data to noninvasively measure absolute myocardial blood flow, flow reserve and relative flow reserve across specific coronary lesions. Results will be compared to those obtained invasively in the catheterization laboratory.
Key facts
- Study ID
- NCT04221594
- Run by
- Emory University
- People needed
- 68
- Starts
- 2019-11-01
- Expected to finish
- 2023-06-30
- Last updated by the study team
- 2023-10-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult (≥18 years of age) - as the research topic to be studied is irrelevant to children
- Written consent form
- Patients with prior dynamic PET or CCTA or ICA for any indications
You may not qualify if…
- Previous history of allergy to iodinated contrast
- Previous CABG
- Serum creatinine levels >1.8 mg/dl unless patient has end stage kidney disease, not producing any urine and dialysis
- History of claustrophobia (CT tunnel length of more than 100 cm)
- Significant arrhythmias or tachycardia
- History of frequent asthma attacks or acting wheezing
- Second- and third-degree heart block
- Systolic blood pressure of < 90 mmHg
- Heart failure with NYHA class III-IV at the time of the CCTA procedure. If it is deemed that, the heart failure has been resolved or the patient was incorrectly labeled as having heart failure the radiology physician in charge will verify the absence of Heart Failure at the time of CCTA and perform the procedure.
- Recent myocardial infarction
- If the patient has been diagnosed with unstable angina within 24 hours prior to CCTA, the patient will not be consented. If the patient does not have the diagnosis of unstable angina and is consented, the radiology physician in charge will verify the absence of unstable angina at the time of CCTA.
- Patients enrolled and consented for the invasive measurements that at the time of catheterization exhibit severe vessel disease and/or obstructions that prevent the operator from safely conducting the measurements will be removed from the study; further research imaging sessions - if planned - will be canceled and patients indicated as "screen failure" in our enrollment log.
Where it is running
- Emory Clinic — Atlanta, Georgia, United States
- Emory University Hospital — Atlanta, Georgia, United States
- Saint Francis Hospital & Heart Center — Roslyn, New York, United States
- Chonnam National University — Gwangju, South Korea
- Samsung Medical Center — Seoul, South Korea
- Seoul National University Hospital — Seoul, South Korea
Full record on ClinicalTrials.gov
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