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Coronary Atherosclerosis T1-Weighted Characterization (CATCH) (CATCH)

Primary Purpose

Coronary Atherosclerosis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cardiac MRI
Contrast
Beta blocker
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Coronary Atherosclerosis focused on measuring MRI technique, High Resolution MRI Technique

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion:

  • 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

Sites / Locations

  • Cedars-Sinai Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Healthy Volunteers

Coronary Artery Disease (CAD) Patients

Arm Description

Approximately 100 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.

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.

Outcomes

Primary Outcome Measures

Plaque to Myocardial Ratio (PMR).
PMR is defined as the ratio between the maximal signal intensity from a vessel wall region and the average signal from an adjacent myocardial area. Such metric is used to classify hyper-intense plaques, also known as "hot spots", which has PMR over 1.0.

Secondary Outcome Measures

Stenosis level (patient group only)
Stenosis level will be evaluated at the vascular segments with visible lumen narrowing in each patient. The extent of a stenosis will be measured and recorded as a percentage, ranging from 0% to 100%, with 100% representing a complete occlusion.

Full Information

First Posted
March 19, 2018
Last Updated
July 18, 2023
Sponsor
Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03504956
Brief Title
Coronary Atherosclerosis T1-Weighted Characterization (CATCH)
Acronym
CATCH
Official Title
Coronary Atherosclerosis T1-Weighted Characterization (CATCH)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 30, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

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.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
Approximately 100 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..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Atherosclerosis
Keywords
MRI technique, High Resolution MRI Technique

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Volunteers
Arm Type
Other
Arm Description
Approximately 100 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.
Arm Title
Coronary Artery Disease (CAD) Patients
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cardiac MRI
Other Intervention Name(s)
Magnetic Resonance Imaging
Intervention Description
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
Drug
Intervention Name(s)
Contrast
Other Intervention Name(s)
contrast agent, Gadavist
Intervention Description
The intravenous gadolinium based contrast agent to be used in this study is Gadavist (up to 0.2 mmol/kg).
Intervention Type
Drug
Intervention Name(s)
Beta blocker
Other Intervention Name(s)
Metoprolol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Plaque to Myocardial Ratio (PMR).
Description
PMR is defined as the ratio between the maximal signal intensity from a vessel wall region and the average signal from an adjacent myocardial area. Such metric is used to classify hyper-intense plaques, also known as "hot spots", which has PMR over 1.0.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Stenosis level (patient group only)
Description
Stenosis level will be evaluated at the vascular segments with visible lumen narrowing in each patient. The extent of a stenosis will be measured and recorded as a percentage, ranging from 0% to 100%, with 100% representing a complete occlusion.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rhona Littman
Phone
310 423-4387
Email
rhona.littman@cshs.org
First Name & Middle Initial & Last Name or Official Title & Degree
Debiao Li, PhD
Phone
310 423-7743
Email
debiao.li@cshs.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debiao Li, PhD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rhona Littman
Phone
310-423-4387
Email
Rhona.Littman@cshs.org
First Name & Middle Initial & Last Name & Degree
Debiao Li, PhD
Phone
310 423-7743
Email
Debiao.Li@cshs.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Coronary Atherosclerosis T1-Weighted Characterization (CATCH)

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