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: September 16, 2014
Last verified: September 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: September 16, 2014
Health Authority: South Korea:Korean Food and Drug Administration

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Coronary Artery Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Coronary Disease
Endocrine System Diseases
Glucose Metabolism Disorders
Heart Diseases
Metabolic Diseases
Vascular Diseases
Iobitridol
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 22, 2014