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

Primary Purpose

Coronary Artery Disease, Atherosclerosis, Coronary Atherosclerosis of Native Coronary Artery

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PET/CT
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring coronary imaging; prevention; early detection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Johns Hopkins HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Main group

Arm Description

All patients undergo both, experimental and standard, tests

Outcomes

Primary Outcome Measures

Correlation of atheroma volume [mm3]
Coronary atheroma volume by PET/CT vs. CT total atheroma volume
Diagnostic accuracy of detecting coronary atherosclerosis
PET/CT Sensitivity to detect any atherosclerosis by CT angiography

Secondary Outcome Measures

Full Information

First Posted
August 8, 2023
Last Updated
August 8, 2023
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT05994014
Brief Title
PET/CT* vs. Cardiac CT for Detecting Coronary Atherosclerotic Disease [*PET: Positron Emission Tomography; CT: Computed Tomography]
Acronym
PET; CT
Official Title
PET/CT vs. Cardiac CT for Detecting Coronary Atherosclerotic Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Atherosclerosis, Coronary Atherosclerosis of Native Coronary Artery
Keywords
coronary imaging; prevention; early detection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Main group
Arm Type
Other
Arm Description
All patients undergo both, experimental and standard, tests
Intervention Type
Diagnostic Test
Intervention Name(s)
PET/CT
Intervention Description
Experimental test for detecting atherosclerosis
Primary Outcome Measure Information:
Title
Correlation of atheroma volume [mm3]
Description
Coronary atheroma volume by PET/CT vs. CT total atheroma volume
Time Frame
60 days
Title
Diagnostic accuracy of detecting coronary atherosclerosis
Description
PET/CT Sensitivity to detect any atherosclerosis by CT angiography
Time Frame
60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Armin A Zadeh, MD PhD MPH
Phone
410-502-0549
Email
azadeh1@jhmi.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tia Thomas, RN, BSN
Phone
410-955-5000
Email
tthoma88@jh.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armin Zadeh, MD PhD MPH
Organizational Affiliation
Johns Hopkins School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
President
First Name & Middle Initial & Last Name & Degree
Armin A Zadeh, MD

12. IPD Sharing Statement

Learn more about this trial

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

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