NCT04837846Completed
Multicenter Study Into Individualized Scanning for Coronary Artery Disease
Source: ClinicalTrials.gov · Last updated 12 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 60 (actual)
- First submitted
- 6 Apr 2021
- Start date
- 29 Mar 2021
- Primary completion date
- 5 Apr 2024
- Lead sponsor
- Medical University of South Carolina
- Diseases
- Coronary artery disease
- NCT number
- NCT04837846
What you commit to
- Study type: Observational
- Participants enrolled: 60
- From 29 Mar 2021 to the primary completion date, 5 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.