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

Not Applicable

Recruiting

• Conditions: Coronary Atherosclerosis of Native Coronary Artery; Coronary Artery Disease; Atherosclerosis
• Interventions: Diagnostic Test: PET/CT

• Registration Number: NCT05994014
• Lead Sponsor: Johns Hopkins University

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).

Study Timeline

• Study Start: 2023-07-01
• Study First Submitted: 2023-08-08
• Study First Submitted QC: 2023-08-08
• Study First Posted: 2023-08-16
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 33

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Main group	PET/CT	All patients undergo both, experimental and standard, tests

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of detecting coronary atherosclerosis	60 days	PET/CT Sensitivity to detect any atherosclerosis by CT angiography
Correlation of atheroma volume [mm3]	60 days	Coronary atheroma volume by PET/CT vs. CT total atheroma volume

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States