Multicenter Study Into Individualized Scanning for Coronary Artery Disease

NCT04837846 | Completed

• 1 other identifier: 00093255
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Prospective CCTA Arm

Other: Differing Tube Voltage Administration

Interventions

Differing Tube Voltage Administration OTHER

Subjects will undergo CCTA utilizing a scan and contrast media injection protocol that will be tailored to individual body habitus.

Prospective CCTA Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with complaints of angina, referred for a clinically indicated CCTA scan

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Joseph U. Schoepf, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: March 29, 2021
• Primary Completion: April 5, 2024
• Study Completion: April 5, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)