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

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ClinicalTrials.gov Identifier: NCT01254552
Recruitment Status : Completed
First Posted : December 6, 2010
Results First Posted : May 31, 2019
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
Guerbet

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Coronary Atherosclerosis Drug: iobitridol Drug: gadoterate meglumine Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 351 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official 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
Actual Study Start Date : August 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dotarem and Xenetix 350 Drug: iobitridol
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 Name: Xenetix

Drug: gadoterate meglumine
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 Outcome Measures :
  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 Outcome Measures :
  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%



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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01254552


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Guerbet
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Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT01254552    
Other Study ID Numbers: ISO-44-011
First Posted: December 6, 2010    Key Record Dates
Results First Posted: May 31, 2019
Last Update Posted: May 31, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action