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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01254552
Recruitment Status : Active, not recruiting
First Posted : December 6, 2010
Last Update Posted : February 24, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study is aimed to answer the clinical question of the prevalence of myocardial scar in asymptomatic patients with type 2 Diabetes Mellitus with a special focus on the diagnostic efficacy of Xenetix® 350-enhanced 64-rows MDCT for the visualisation of the coronary arterial tree and secondarily for the assessment of myocardial viability when using Dotarem® enhanced-cardioMR as the gold standard examination.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 351 participants
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
Study Start Date : August 2010
Primary Completion Date : September 2011
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Iobitridol Drug: Iobitridol
Xenetix 350

Outcome Measures

Primary Outcome Measures :
  1. Prevalence of occult myocardial scar on DE-MRI in asymptomatic patients with type 2 diabetes mellitus [ Time Frame: one year ]

Eligibility Criteria

Information from the National Library of Medicine

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

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
Contacts and Locations

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

Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Principal Investigator: T.H. LIM, Pr Asan Medical Center
More Information

Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT01254552     History of Changes
Other Study ID Numbers: ISO-44-011
First Posted: December 6, 2010    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Coronary Artery Disease
Myocardial Ischemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases