Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04837846
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
U. Joseph Schoepf, MD, Medical University of South Carolina

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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.


Condition or disease Intervention/treatment
Coronary Artery Disease Other: Differing Tube Voltage Administration

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Multicenter Study Into Individualized Scanning for Coronary Artery Disease
Actual Study Start Date : March 29, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with complaints of angina, referred for a clinically indicated CCTA scan
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04837846


Contacts
Layout table for location contacts
Contact: Jordan Fash, MHA 843-876-7148 fash@musc.edu
Contact: Lauren Ellis ellisla@musc.edu

Locations
Layout table for location information
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Jordan Fash, MHA    843-876-7148    fash@musc.edu   
Contact: Lauren Ellis       ellisla@musc.edu   
Principal Investigator: Joseph Schoepf, MD         
Sponsors and Collaborators
Medical University of South Carolina
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: U. Joseph Schoepf, MD, Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT04837846    
Other Study ID Numbers: 00093255
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases