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

Diabetes Clinical Trial

— CTRAD  

Official title:

Role of Cardiac CT in Risk Factor Control in Asymptomatic Patients With Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01564485
• Other study ID #: 2008-6170
• Status: Completed
• Phase: N/A
• Start date: July 2008
• Est. completion date: December 2016

Study information

• Verified date: June 2021
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This study examined whether doing a cardiac screening test, the cardiac CT, would result in patients paying more attention to controlling their risk factors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Age > 18

• Diabetes

• Metabolic Syndrome

Exclusion Criteria:

• Symptoms of heart disease

• Heart Disease

• Renal disease

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Metabolic Syndrome
• Syndrome

Intervention

Diagnostic Test:
• Cardiac CT
A cardiac CT involves a non-invasive test of the coronary arteries.

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of California, Irvine Medical Center	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Treatment by PCP	Medication dose change or medication start/stop	2 years
Primary	Systolic BP Pressure	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 a continuous measure.	Five year follow up