Multicenter Study Into Individualized Scanning for Coronary Artery Disease (MINDS-CAD)

February 12, 2024 updated by: U. Joseph Schoepf, MD, Medical University of South Carolina

To evaluate intravascular attenuation of the coronary arteries and image quality in an individualized scan and CM injection protocol whereas both scan and injection parameters are tailored to the individual patient in a North American, European and Asian patient population.

To evaluate the radiation dose and contrast media dose of this individualized approach for CCTA in an American, European and Chinese patient population.

To evaluate the injection parameters required for an average American, European and Chinese patient population.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mark Ghent, BA
  • Phone Number: 843-876-7148
  • Email: ghent@musc.edu

Study Contact Backup

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
          • Jordan Fash, MHA
          • Phone Number: 843-876-7148
          • Email: fash@musc.edu
        • Contact:
        • Principal Investigator:
          • Joseph Schoepf, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults with complaints of angina, referred for a clinically indicated CCTA scan

Description

Inclusion Criteria:

  • To be eligible for the study: (All answers must be "YES" for subject to be eligible.)

    1. Referred for a clinically indicated CCTA scan.
    2. Patient aged older than 18.
    3. Subject must provide written informed consent prior to any study-related procedures being performed.
    4. Subject must be willing to comply with all clinical study procedures.
    5. Atypical or typical complaints of angina.
    6. No previous cardiovascular history.
    7. Possibility of 'flash' mode scan; patient heart rate below 70 beats per minute and regular rhythm.

Exclusion Criteria:

  • The presence of the following excludes subjects from the study: (All answers must be "NO" for subject to be eligible.)

    1. Contraindications for CT coronary angiography, including:

      1. Inability to perform a breath hold for at least the expected scan time
      2. Unstable angina
      3. Hemodynamic instability
      4. Known history of CAD
      5. Pregnancy
      6. Renal insufficiency (defined as Creatinine <1.5 mg/dL or GFR<30 mL/min)
      7. Iodine allergy
    2. Insufficient cannula venous access (preferred 18G, minimal 20G cannula)
    3. Subject has an acute psychiatric disorder.
    4. Subject is unwilling to comply with the requirements of the protocol.
    5. Subject has previously entered this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prospective CCTA Arm
Other: Differing Tube Voltage Administration
Subjects will undergo CCTA utilizing a scan and contrast media injection protocol that will be tailored to individual body habitus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Intravascular Attenuation
Time Frame: At time of CCTA scan
To measure the amount of Hounsfield units in different anatomical structures produced by an amount of contrast media. Using Hounsfield units coupled with image quality to determine if a scan of diagnostic value has been attained.
At time of CCTA scan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

April 6, 2021

First Submitted That Met QC Criteria

April 6, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Estimated)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00093255

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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