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

NCT05994014 | Recruiting FDA Device

• 1 other identifier: IRB00317553
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Atherosclerosis; Coronary Atherosclerosis of Native Coronary Artery

Keywords

coronary imaging; prevention; early detection

Outcome Measures

Primary Outcomes (2)

• Correlation of atheroma volume [mm3]

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

  60 days

• Diagnostic accuracy of detecting coronary atherosclerosis

  PET/CT Sensitivity to detect any atherosclerosis by CT angiography

  60 days

Study Arms (1)

Main group

OTHER

All patients undergo both, experimental and standard, tests

Diagnostic Test: PET/CT

Interventions

PET/CT DIAGNOSTIC_TEST

Experimental test for detecting atherosclerosis

Main group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients
• years or older
• referred for coronary CT angiography because of suspected coronary heart disease (CHD) with stable symptoms

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Armin Zadeh, MD PhD MPH

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Armin A Zadeh, MD PhD MPH

CONTACT

410-502-0549; azadeh1@jhmi.edu

Tia Thomas, RN, BSN

CONTACT

410-955-5000; tthoma88@jh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 16, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

US (1)