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Completed

NCT Number: NCT01254552

Assessment With CCTA and MRI in Asymptomatic Patients With Type 2 Diabetes for Detection of Unrecognized Myocardial Scar in Subclinical Coronary Atherosclerosis

The study aimed to prospectively investigate the prevalence of myocardial scar on Dotarem-enhanced Cardiovascular Magnetic Resonance Imaging (MRI) in asymptomatic patients with type-2 Diabetes Mellitus and to assess its correlation with subclinical coronary artery disease on Cardiac Computed Tomography Angiography (CCTA).

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Key information

Conditions

Type 2 Diabetes Mellitus Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Atherosclerosis Coronary Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asan Medical Center

Seoul, South Korea

About this study

Patients underwent a cardiac MRI examination with Dotarem within 60 days after screening visit. The myocardial CCTA examination with Xenetix 350 was performed within 1 to 30 days (but no sooner than 24 hours) after the MRI examination.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient with onset of type 2 diabetes occurred at age 30 years or older
  • Patient between the ages of 50 and 75 years at enrolment time
  • Patient with at least two identified cardiac risk factors who will undergo a CMR and a CCTA examinations to evaluate his/her coronary and cardiac status

Exclusion criteria

  • Patient with angina pectoris or chest discomfort
  • Patient with stress test or invasive coronary angiography within the prior 3 years
  • Patient with history of myocardial infarction, overt non compensated heart failure, or coronary revascularization
  • Patient with hemodynamic instability.
  • Patient with a contraindication or intolerance to Beta-Blocker administration

Treatment and study plan

iobitridol

Drug

Xenetix 350 was administered at a dose up to 180 ml, according to the patient's body weight measured on the day of administration.

Other names: Xenetix

Gadoterate meglumine

Drug

Dotarem was administered at a dose of 0.1 mmol/kg body weight (0.2 ml/kg body weight)

Other names: gadoteric acid, Dotarem

Primary outcomes

  1. Prevalence of Occult Myocardial Scar on Delayed-enhanced MRI in Asymptomatic Patients With Type 2 Diabetes Mellitus

    Time frame: From 1 week to 2 months (after the collection of data corresponding to cardiac MRI and CCTA examinations)

Secondary outcomes

  1. Number of Patients With and Without Occult Myocardial Scar on Cardiac MRI According to the Degree of Stenosis

    Time frame: From 1 week to 2 months (after the collection of data corresponding to cardiac MRI and CCTA examinations)

    The degree of coronary artery stenosis on CCTA was assessed according to the following scale:

    • No stenosis: 0%
    • Non significant stenosis: 1-50%
    • Significant stenosis >50% and ≤99%
    • Occlusion: 100%

Sponsors and collaborators

Lead sponsor

Guerbet

Industry

Registry information

Official study title

Assessment With Cardiac Computed Tomography Angiography (CCTA) and Magnetic Resonance Imaging (MRI) in Asymptomatic Patients With Type 2 Diabetes for Detection of Unrecognized Myocardial Scar in Subclinical Coronary Atherosclerosis

Acronym: ACCREDIT

Important dates

Study start
2010
Primary completion
2011
Study completion
2016
First posted
Dec 6, 2010
Registry last updated
May 31, 2019

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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