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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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Guerbet
ClinicalTrials.gov Identifier:
NCT01254552
First received: October 13, 2010
Last updated: October 1, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
Coronary Atherosclerosis
 Drug: Iobitridol
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Guerbet:

Primary Outcome Measures:
  • Prevalence of occult myocardial scar on DE-MRI in asymptomatic patients with type 2 diabetes mellitus [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 351
Study Start Date: August 2010
Estimated Study Completion Date: December 2016
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Iobitridol Drug: Iobitridol
Xenetix 350

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01254552

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

No publications provided

Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT01254552     History of Changes
Other Study ID Numbers: ISO-44-011
Study First Received: October 13, 2010
Last Updated: October 1, 2012
Health Authority: South Korea:Korean Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 21, 2013