Status:
COMPLETED
Multicenter Study Into Individualized Scanning for Coronary Artery Disease
Lead Sponsor:
Medical University of South Carolina
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
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 indi...
Eligibility Criteria
Inclusion
- To be eligible for the study: (All answers must be "YES" for subject to be eligible.)
- Referred for a clinically indicated CCTA scan.
- Patient aged older than 18.
- Subject must provide written informed consent prior to any study-related procedures being performed.
- Subject must be willing to comply with all clinical study procedures.
- Atypical or typical complaints of angina.
- No previous cardiovascular history.
- Possibility of 'flash' mode scan; patient heart rate below 70 beats per minute and regular rhythm.
Exclusion
- The presence of the following excludes subjects from the study: (All answers must be "NO" for subject to be eligible.)
- Contraindications for CT coronary angiography, including:
- Inability to perform a breath hold for at least the expected scan time
- Unstable angina
- Hemodynamic instability
- Known history of CAD
- Pregnancy
- Renal insufficiency (defined as Creatinine \<1.5 mg/dL or GFR\<30 mL/min)
- Iodine allergy
- Insufficient cannula venous access (preferred 18G, minimal 20G cannula)
- Subject has an acute psychiatric disorder.
- Subject is unwilling to comply with the requirements of the protocol.
- Subject has previously entered this study.
Key Trial Info
Start Date :
March 29 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 5 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04837846
Start Date
March 29 2021
End Date
April 5 2024
Last Update
November 12 2024
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425