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

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: Coronary Artery Disease; Atherosclerosis; Coronary Atherosclerosis of Native Coronary Artery
• Intervention / Treatment: Diagnostic test: PET/CT

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

• 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

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

How is the study designed?

Design Details

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

Number of Arms

1

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]	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

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): August 16, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: coronary imaging; prevention; early detection
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Atherosclerosis
• 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