Multicenter Study Into Individualized Scanning for Coronary Artery Disease

Completed

• Conditions: Coronary Artery Disease
• Interventions: Other: Differing Tube Voltage Administration

• Registration Number: NCT04837846
• Lead Sponsor: Medical University of South Carolina

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-29
• Study First Submitted: 2021-04-06
• Study First Submitted QC: 2021-04-06
• Study First Posted: 2021-04-08
• Primary Completion: 2024-04-05
• Study Completion: 2024-04-05
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective CCTA Arm	Differing Tube Voltage Administration	-

Primary Outcome Measures

Name	Time	Method
Evaluation of Intravascular Attenuation	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.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States