Atherosclerosis, Coronary Artery Disease, Coronary Atherosclerosis of Native Coronary Artery
Conditions
Keywords
coronary imaging, prevention, early detection
Brief summary
Early detection of coronary atherosclerotic disease facilitates adequate prevention. The purpose of this study is to compare an assessment of coronary atherosclerotic disease burden by positron emission tomography / computed tomography (NaF-PET/CT) with those of conventional and ultra-high-resolution-CT (UHR-CT) in patients with suspected coronary artery disease. For this purpose, the investigators plan to include 33 patients with symptoms concerning for CAD who have been referred for cardiac CT testing.
Detailed description
Early detection of coronary atherosclerotic disease facilitates adequate prevention. 18 Fluoride (F) -sodium fluoride PET/CT (NaF-PET/ CT) has been shown to detect aortic microcalcification as early manifestation of atherosclerosis in experimental and early clinical investigations. The capability of NaF-PET/CT to detect coronary atherosclerotic disease in humans remains unclear. Given its sensitivity to detect vascular microcalcification undetectable by conventional CT, NaF-PET/CT may be an attractive, noninvasive test for early detection of coronary atherosclerosis. The purpose of this study is to compare an assessment of coronary atherosclerotic disease burden by positron emission tomography / computed tomography (NaF-PET/CT) with those of conventional and ultra-high-resolution-CT (UHR-CT) in patients with suspected coronary artery disease (CAD). For this purpose, the investigators plan to include 33 patients with symptoms concerning for CAD who have been referred for cardiac CT testing. In addition to the clinically indicated and performed cardiac CT scan, participants will be asked to also undergo NaF-PET/CT for comparison of atherosclerosis assessment among the two tests (single center, prospective diagnostic accuracy study).
Interventions
DIAGNOSTIC_TESTPET/CT
Experimental test for detecting atherosclerosis
Sponsors
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patients * 18 years or older * referred for coronary CT angiography because of suspected coronary heart disease (CHD) with stable symptoms
Exclusion criteria
* The patient has a history of coronary heart disease, defined by prior myocardial infarction or prior coronary artery revascularization. * Pregnancy. * Atrial fibrillation. * Morbid obesity defines as a body mass index of \>40. * The patient has any other clinically significant medical condition that in the opinion of the Investigator could impact the patient's ability to successfully complete the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of atheroma volume [mm3] | 60 days | Coronary atheroma volume by PET/CT vs. CT total atheroma volume |
| Diagnostic accuracy of detecting coronary atherosclerosis | 60 days | PET/CT Sensitivity to detect any atherosclerosis by CT angiography |
Countries
United States
Contacts
CONTACTArmin A Zadeh, MD PhD MPH
CONTACTTia Thomas, RN, BSN
PRINCIPAL_INVESTIGATORArmin Zadeh, MD PhD MPH
Johns Hopkins School of Medicine
Outcome results
None listed