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Cardiac CT's Role in Asymptomatic Patients With Diabetes and Metabolic Syndrome (CTRAD)

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. Identifier: NCT01564485
Recruitment Status : Completed
First Posted : March 27, 2012
Last Update Posted : December 8, 2016
Information provided by (Responsible Party):
Shaista Malik, University of California, Irvine

Brief Summary:
This study looked at the role of cardiac CT in improving risk factor control in those with diabetes.

Condition or disease Intervention/treatment Phase
Diabetes Metabolic Syndrome Procedure: Cardiac CT Drug: Usual medical care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 198 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Role of Cardiac CT in Risk Factor Control in Asymptomatic Patients With Diabetes
Study Start Date : July 2008
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Cardiac CT
Patients randomized to cardiac CT will obtain a non-invasive assessment of their coronary arteries.
Procedure: Cardiac CT
A cardiac CT involves a non-invasive test of the coronary arteries.

Placebo Comparator: Usual Care
Patients randomized to usual care will be assigned to continuing usual medical care with their primary care physician
Drug: Usual medical care
Patients would be treated by their primary care physicians with usual medical care with drugs such as lipid lowering medication, blood pressure lowering medications, and blood glucose lowering medications. The study will not specify which drugs to use and will it up to the individual physician's discretion.
Other Name: Usual medical care would include control of blood pressure, blood glucose, and cholesterol by the primary care physician.

Primary Outcome Measures :
  1. Systolic BP pressure [ Time Frame: Five year follow up ]
    After randomization to either obtain cardiac CT or usual care, patients will be followed for 5 years (with assessment of outcomes at every 6 months) to see any difference in control of systolic blood pressure. The outcome with be assessed as both a continuous measure, as well as a categorical variable (<135 mm Hg, and >=135 mmHg)

  2. Control of LDL cholesterol [ Time Frame: 5 years ]
    We will assess the control of LDL cholesterol at 6 month intervals for a total of 5 years. We will assess this measure as a continuous variable and as a a dichotomous outcome (LDL < or = 100 or LDL >100)

  3. Hemoglobin A1c [ Time Frame: 5 years ]
    After the cardiac CT, we will assess if patients have better control of their hemoglobin A1c (we will assess every 6 months for a total of 5 years). This will be a continuous measure.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age > 18
  • Diabetes
  • Metabolic Syndrome

Exclusion Criteria:

  • Symptoms of heart disease
  • Heart Disease
  • Renal disease

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 identifier (NCT number): NCT01564485

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United States, California
University of California, Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
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Principal Investigator: Shaista Malik, MD, PhD University of California, Irvine
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Responsible Party: Shaista Malik, Assistant Professor, University of California, Irvine Identifier: NCT01564485    
Other Study ID Numbers: 20086170
First Posted: March 27, 2012    Key Record Dates
Last Update Posted: December 8, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Diabetes Mellitus
Metabolic Syndrome
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Insulin Resistance