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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: February 23, 2017
Last verified: February 2017
  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: 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

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 ]

Enrollment: 351
Study Start Date: August 2010
Estimated Study Completion Date: October 2017
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   (Adult, Senior)
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
  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

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: February 23, 2017

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

ClinicalTrials.gov processed this record on September 18, 2017