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OpenTrials
Completed

NCT Number: NCT04837846

Multicenter Study Into Individualized Scanning for Coronary Artery Disease

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.

Completed

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Evaluation of Intravascular Attenuation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Acronym: MINDS-CAD

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 8, 2021
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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