Coronary Atherosclerosis T1-Weighted Characterization (CATCH)

NCT ID: NCT03504956

Last Updated: 2025-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-30

Study Completion Date

2026-12-31

Brief Summary

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This study proposes to develop an MRI technique named Coronary Atherosclerosis T1-weighed Characterization (CATCH) that will improve the quality and reliability of coronary atherosclerosis evaluation, as well as simplify the scanning process and significantly shorten imaging time compared with conventional imaging methods.

Detailed Description

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Approximately 110 healthy male/female adult "normals" or "controls" and 40 male/female adult outpatients who are suspected of having or have been diagnosed with coronary artery disease will be recruited. All subjects will be asked to undergo either a non-contrast MRI or a contrast-enhanced MRI of the coronary artery depending upon the focus of development at the time of their participation

It is anticipated that healthy volunteers will undergo non-contrast or contrast-enhanced MRI for evaluating the image quality associated with each acquisition module of the developed technique and motion artifact associated with motion compensation strategy. For subjects receiving contrast, a total dose of up to 0.2 mmol/kg of a gadolinium based contrast agent will be injected intravenously provided all the safety requirements are met.

Subjects undergoing a contrast-enhanced MRI will be screened using the standard clinical protocol to determine whether it is safe to administer contrast. If subjects do not qualify for contrast administration, they may be asked to have a research scan without contrast.

Research MRI results will be compared with clinical diagnostic CT and/or invasive imaging studies for patients who have been evaluated with these exams at Cedars-Sinai Medical Center..

Conditions

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Coronary Atherosclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Healthy Volunteers

Approximately 110 healthy male/female adult "normals" or "controls" will receive non-contrast or contrast-enhanced Cardiac MRI. Imaging may include administration of contrast and a beta blocker, based upon the focus of the study at the time of the scan, as well as the safety profile of the participant.

Group Type OTHER

Cardiac MRI

Intervention Type DEVICE

MRI with/without administration of a contrast agent and beta-blocker based upon the stage of method development, if no contraindications are present.

Contrast

Intervention Type DRUG

The intravenous gadolinium based contrast agent to be used in this study is Gadavist (up to 0.2 mmol/kg).

Beta blocker

Intervention Type DRUG

Based upon the focus of the study at the time of the scan, a beta- blocker (metoprolol), in pill form based upon blood pressure and heart rate, may be administered to some subjects to improve the heart's ability to relax and slow the heart rate. The slower heart rate may improve image quality and lessen motion artifact.

Coronary Artery Disease (CAD) Patients

40 male/female adult outpatients who are suspected of having or have been diagnosed with coronary artery disease (CAD) will receive non-contrast or contrast-enhanced Cardiac MRI. Imaging may include administration of contrast and a beta blocker, based upon the focus of the study at the time of the scan, as well as the safety profile of the participant.

Group Type OTHER

Cardiac MRI

Intervention Type DEVICE

MRI with/without administration of a contrast agent and beta-blocker based upon the stage of method development, if no contraindications are present.

Contrast

Intervention Type DRUG

The intravenous gadolinium based contrast agent to be used in this study is Gadavist (up to 0.2 mmol/kg).

Beta blocker

Intervention Type DRUG

Based upon the focus of the study at the time of the scan, a beta- blocker (metoprolol), in pill form based upon blood pressure and heart rate, may be administered to some subjects to improve the heart's ability to relax and slow the heart rate. The slower heart rate may improve image quality and lessen motion artifact.

Interventions

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Cardiac MRI

MRI with/without administration of a contrast agent and beta-blocker based upon the stage of method development, if no contraindications are present.

Intervention Type DEVICE

Contrast

The intravenous gadolinium based contrast agent to be used in this study is Gadavist (up to 0.2 mmol/kg).

Intervention Type DRUG

Beta blocker

Based upon the focus of the study at the time of the scan, a beta- blocker (metoprolol), in pill form based upon blood pressure and heart rate, may be administered to some subjects to improve the heart's ability to relax and slow the heart rate. The slower heart rate may improve image quality and lessen motion artifact.

Intervention Type DRUG

Other Intervention Names

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Magnetic Resonance Imaging contrast agent Gadavist Metoprolol

Eligibility Criteria

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Inclusion Criteria

* Healthy Volunteers: male or female ≥ 18 years of age with a BMI\<30, with no history of cardiovascular disease
* Patients: Medically stable, male or female ≥ 18 years of age who is have not suspected of having or has been diagnosed with coronary artery disease and undergone stenting or bypass surgery

Exclusion:

* Contraindications to MR imaging including mechanically, magnetically, or electrically activated implants, ferromagnetic implants and ferromagnetic foreign bodies, pregnancy.
* Inability to tolerate MR imaging secondary to an inability to hold breath for a short time or have claustrophobia.
* Non-compliant with visit instructions, including following procedure instructions
* Severe allergy to animal dander or animal-instigated asthma
* Specific to gadolinium-based contrast agents: Renal function test does not meet CSMC standard of care MRI contrast protocol requirements (GFR \<45ml/min) or previous allergic reaction to gadolinium-based contrast agents.\*
* Volunteers who have had four or more prior previous gadolinium contrast scan
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cedars-Sinai Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Debiao Li, PhD

Director, Biomedical Imaging Research Institute

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Debiao Li, PhD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

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Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Rosalia (Sally) A De Leon

Role: CONTACT

310 423-7758

Debiao Li, PhD

Role: CONTACT

310 423-7743

Facility Contacts

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Rhona Littman

Role: primary

310 423-4387

Debiao Li, PhD

Role: backup

310 423-7743

Other Identifiers

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45312

Identifier Type: -

Identifier Source: org_study_id

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