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

June 7, 2021 updated by: Shaista Malik, University of California, Irvine

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

193

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • University of California, Irvine Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 18
  • Diabetes
  • Metabolic Syndrome

Exclusion Criteria:

  • Symptoms of heart disease
  • Heart Disease
  • Renal disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cardiac CT
Patients randomized to cardiac CT will obtain a non-invasive assessment of their coronary arteries.
Diagnostic test: Cardiac CT
A cardiac CT involves a non-invasive test of the coronary arteries.
ACTIVE_COMPARATOR: Usual Care
Patients randomized to usual care will be assigned to continuing usual medical care with their primary care physician
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.
Other Names:
  • Usual medical care would include control of blood pressure, blood glucose, and cholesterol by the primary care physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 a continuous measure.
Five year follow up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Treatment by PCP
Time Frame: 2 years
Medication dose change or medication start/stop
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Investigators

  • Principal Investigator: Shaista Malik, MD, PhD, University of California, Irvine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

February 24, 2012

First Submitted That Met QC Criteria

March 23, 2012

First Posted (ESTIMATE)

March 27, 2012

Study Record Updates

Last Update Posted (ACTUAL)

June 8, 2021

Last Update Submitted That Met QC Criteria

June 7, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-6170

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified data will be available

IPD Sharing Time Frame

Data is now available

IPD Sharing Access Criteria

We will need written request to share data

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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