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NCT05994014 Clinical Trial

PET/CT* vs. Cardiac CT for Detecting Coronary Atherosclerotic Disease [*PET: Positron Emission Tomography; CT: Computed Tomography]

Coronary Artery Disease Clinical Trial

— PET; CT  

Official title:
PET/CT vs. Cardiac CT for Detecting Coronary Atherosclerotic Disease

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05994014
Other study ID # IRB00317553
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2023
Est. completion date June 2026

Study information
Verified date August 2023
Source Johns Hopkins University
Contact Armin A Zadeh, MD PhD MPH
Phone 410-502-0549
Email azadeh1@jhmi.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Recruiting
Enrollment 33
Est. completion date June 2026
Est. primary completion date June 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• PET/CT
Experimental test for detecting atherosclerosis

Locations
Country Name City State
United States Johns Hopkins Hospital Baltimore Maryland

Sponsors (1)
Lead Sponsor Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation of atheroma volume [mm3] Coronary atheroma volume by PET/CT vs. CT total atheroma volume 60 days
Primary Diagnostic accuracy of detecting coronary atherosclerosis PET/CT Sensitivity to detect any atherosclerosis by CT angiography 60 days
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