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
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Atherosclerosis of Native Coronary Artery
• Myocardial Ischemia

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