Multicenter Study Into Individualized Scanning for Coronary Artery Disease

Coronary Artery Disease Clinical Trial

— MINDS-CAD  

Official title:

Multicenter Study Into Individualized Scanning for Coronary Artery Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04837846
• Other study ID #: 00093255
• Status: Recruiting
• Start date: March 29, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Medical University of South Carolina
• Contact: Mark Ghent, BA
• Phone: 843-876-7148
• Email: ghent[@]musc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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