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

June 5, 2026 updated by: Johns Hopkins University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Armin A Zadeh, MD PhD MPH
  • Phone Number: 410-502-0549
  • Email: azadeh1@jhmi.edu

Study Contact Backup

  • Name: Tia Thomas, RN, BSN
  • Phone Number: 410-955-5000
  • Email: tthoma88@jh.edu

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Hospital
        • Contact:
          • President
        • Principal Investigator:
          • Armin A Zadeh, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Main group
All patients undergo both, experimental and standard, tests
Diagnostic test: PET/CT
Experimental test for detecting atherosclerosis

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Armin Zadeh, MD PhD MPH, Johns Hopkins School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

August 8, 2023

First Submitted That Met QC Criteria

August 8, 2023

First Posted (Actual)

August 16, 2023

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 5, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00317553

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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