Clinical trial NCT04221594: Quantification of Myocardial Blood Flow Using Dynamic PET/CTA Fused Imagery
Official title: Quantification of Myocardial Blood Flow Using Dynamic PET/CTA Fused Imagery to Determine the Physiological Significance of Specific Coronary Lesions.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Fractional flow reserve
Myocardial blood flow
Relative flow reserve
Non-invasive measure
Cardiac catheterization
CT coronary angiography
Dynamic PET
Invasive coronary angiography
3D fusion dPET/CTA
FFRCT
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Samsung Medical Center
name: Seoul National University
name: Chonnam National University Hospital
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-01-09
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with angina referred to an initial imaging test for the assessment of CAD will be screened and considered for inclusion in the study. Different hospital policies and guidelines determine which initial test is commonly requested: at Emory University Hospital patients who underwent a dPET will be considered for enrollment; at the South Korean centers patients who received a CTA will be screened. Depending on test results, patients who are referred to undergo a cardiac catheterization, will be invited to participate in the study.

Brief summary: 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.

Detailed description: 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. These results will be compared to those obtained invasively in the catheterization laboratory. The long-term objective of the study is to improve the care of cardiac patients by developing, validating and implementing clinically computer-based methods to noninvasively determine the physiological significance of specific coronary lesions using methods to fuse and quantify multi-modality cardiac imagery.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Myocardial blood flow (MBF) measurement comparing non-invasive to the traditional approaches
timeFrame: Up to 3 months
measure: Vessel-specific quantification of myocardial blood flow RFR
timeFrame: Up to 3 months
Secondary outcomes:
measure: Absolute myocardial blood flow (MBF) measurement comparing non-invasive to the traditional approaches
timeFrame: Up to 3 months
measure: Myocardial flow reserve (MFR) measurement comparing non-invasive to the traditional approaches
timeFrame: Up to 3 months
measure: Fractional Flow Reserve (FFR) measurement comparing non-invasive to the traditional approaches
timeFrame: Up to 3 months
measure: Stress myocardial blood flow (sMBF)/Regional myocardial blood flow (rMBF) ratio
timeFrame: Up to 3 months
measure: Distal/proximal pressure ratio
timeFrame: Up to 3 months
measure: Discriminatory power of dPET/CTA. And FFR(CTA)
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Clinic
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Roslyn
country: United States
facility: Saint Francis Hospital & Heart Center
state: New York
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Emory University
name: Marina Piccinelli, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: AlBadri A, Piccinelli M, Cho SG, Lee JM, Jaber W, De Cecco CN, Samady H, Koo BK, Bom HS, Garcia EV. Rationale and design of the quantification of myocardial blood flow using dynamic PET/CTA-fused imagery (DEMYSTIFY) to determine physiological significance of specific coronary lesions. J Nucl Cardiol. 2020 Jun;27(3):1030-1039. doi: 10.1007/s12350-020-02052-0. Epub 2020 Feb 5.