Cardiac CT's Role in Asymptomatic Patients With Diabetes and Metabolic Syndrome (CTRAD)
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|ClinicalTrials.gov Identifier: NCT01564485|
Recruitment Status : Completed
First Posted : March 27, 2012
Last Update Posted : December 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Metabolic Syndrome||Procedure: Cardiac CT Drug: Usual medical care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||198 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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)
- 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)
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01564485
|United States, California|
|University of California, Irvine Medical Center|
|Orange, California, United States, 92868|
|Principal Investigator:||Shaista Malik, MD, PhD||University of California, Irvine|