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

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Johns Hopkins University

Status

Enrolling

Conditions

Coronary Atherosclerosis of Native Coronary Artery
Coronary Artery Disease
Atherosclerosis

Treatments

Diagnostic Test: PET/CT

Study type

Interventional

Funder types

Other

Identifiers

NCT05994014
IRB00317553

Details and patient eligibility

About

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.

Full 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).

Enrollment

33 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

33 participants in 1 patient group

Main group
Other group
Description:
All patients undergo both, experimental and standard, tests
Treatment:
Diagnostic Test: PET/CT

Trial contacts and locations

1

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Central trial contact

Armin A Zadeh, MD PhD MPH; Tia Thomas, RN, BSN

Data sourced from clinicaltrials.gov

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