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Coronary Computed Tomography Angiography and SPECT in Asymptomatic Diabetes

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT00431717
First received: February 5, 2007
Last updated: August 22, 2008
Last verified: August 2008
History of Changes
  Purpose

The purpose of this study is to compare the difference of diagnostic efficiency between coronary CT angiography and myocardial perfusion single photon emission computerized tomography in asymptomatic patients with type 2 diabetes mellitus.


Condition
Coronary Atherosclerosis
Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study Comparing Coronary Computed Tomography Angiography and SPECT to Detect Subclinical Coronary Atherosclerosis in Asymptomatic Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Bundang Hospital:

Enrollment: 116
Study Start Date: November 2006
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Detailed Description:

Coronary artery disease (CAD) is the leading cause of death in patients with diabetes. Patients with diabetes are known to have silent myocardial ischemia more frequently than those without diabetes. Furthermore, CAD in patients with diabetes frequently manifested in advance stage, and morbidity and mortality are higher than those without diabetes. Early screening and treatment of CAD in asymptomatic patients with diabetes might reduce high morbidity and mortality.

Myocardial perfusion single photon emission computerized tomography (SPECT) is known as a gold standard method in detecting silent myocardial ischemia in asymptomatic patients with diabetes. Despite of the power of detecting myocardial ischemia functionally, there are limitations of SPECT in diagnosing subclinical coronary atherosclerosis anatomically. In recent advance in technology, coronary CT angiography (CTA) could detect subclinical coronary atherosclerosis. However, there is a paucity of information comparing the diagnostic power between SPECT and CTA.

Therefore in our study, we compare the difference of diagnostic efficiency between coronary CT angiography and myocardial perfusion single photon emission computerized tomography in asymptomatic patients with type 2 diabetes mellitus.

In this study, we will recruit asymptomatic patients with diabetes. At the time of enrollment, all patients will undergo two imaging studies (SPECT and CTA) within a few days apart. When patients had positive result in either study, they will undergo coronary angiography for confirmation. We will evaluate the results of two studies comparing with coronary angiography. When the patients are eligible for study, investigators will give information about the study and obtain written consent. The presence of chest pain symptom will be screened with Rose questionnaire. Medical history and physical examination will be performed, and baseline laboratory work-up will be performed. Investigators will evaluate the status of diabetic complication (retinopathy/nephropathy/cardiac autonomic neuropathy).

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Asymptomtaic type 2 diabetes mellitus with multiple risk factors

Criteria

Inclusion Criteria:

  1. Type 2 diabetes mellitus
  2. Age 50 ~ 75 years
  3. Duration of diabetes: more than 5 years
  4. More than two of the following risk factors in addition to diabetes:

1)dyslipidemia, 2)hypertension, 3)smoking, 4)family history of premature coronary artery disease

Exclusion Criteria:

  1. Angina pectoris or anginal equivalent symptoms
  2. Insulin pump user or history of ketoacidosis
  3. History of myocardial infarction, heart failure, or coronary revascularization
  4. Electrocardiographic evidence of Q-wave myocardial infarction, ischemic ST- segment or T-wave changes, or complete left bundle branch block
  5. Uncontrolled arrythmia
  6. Hypersensitivity to contrast dye
  7. Renal failure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00431717

Locations
Korea, Republic of
Seoul National University Bundang hospital
Sungnam-si, Kyungki-do, Korea, Republic of
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Study Director: Huk-Jae Chang, MD, PhD Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Hyuk-Jae Chang MD, PhD, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT00431717     History of Changes
Other Study ID Numbers: B-0609/037-019
Study First Received: February 5, 2007
Last Updated: August 22, 2008
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Bundang Hospital:
Coronary Atherosclerosis
Diabetes Mellitus

Additional relevant MeSH terms:
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Diabetes Mellitus
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 23, 2013