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

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: Coronary Artery Disease
• Intervention / Treatment: Other: Differing Tube Voltage Administration

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Mark Ghent, BA; Phone Number: 843-876-7148; Email: ghent@musc.edu
• Study Contact Backup: Name: Vincent Giovagnoli, BS; Phone Number: 843-876-4922; Email: giovagnv@musc.edu

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: Lauren Ellis; Email: ellisla@musc.edu
      • Principal Investigator: Joseph Schoepf, MD

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

1

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	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

• Sponsor: Medical University of South Carolina

Study record dates

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: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• 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