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NCT Number: NCT05994014

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location status: Recruiting

Location contact

Armin A Zadeh, MD

PRINCIPAL_INVESTIGATOR

President

CONTACT

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PET/CT

Diagnostic Test

Experimental test for detecting atherosclerosis

Primary outcomes

  1. Correlation of atheroma volume [mm3]

    Time frame: 60 days

    Coronary atheroma volume by PET/CT vs. CT total atheroma volume

  2. Diagnostic accuracy of detecting coronary atherosclerosis

    Time frame: 60 days

    PET/CT Sensitivity to detect any atherosclerosis by CT angiography

Study contacts

Contact information is provided by the study sponsor or research team.

Armin A Zadeh, MD PhD MPH

CONTACT

[email protected]

410-502-0549

Tia Thomas, RN, BSN

CONTACT

[email protected]

410-955-5000

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

PET/CT vs. Cardiac CT for Detecting Coronary Atherosclerotic Disease

Acronym: PET; CT

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Aug 16, 2023
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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