Screening For Asymptomatic Obstructive Coronary Artery Disease Among High-Risk Diabetic Patients Using CT Angiography, Following Core 64 (faCTor-64)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Deseret Foundation
Toshiba America Medical Systems, Inc.
Information provided by (Responsible Party):
Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier:
NCT00488033
First received: June 15, 2007
Last updated: August 2, 2013
Last verified: August 2013
  Purpose

Patients with a known history of diabetes mellitus and no prior documented evidence of cardiovascular disease will be evaluated for inclusion in the study. Once qualified, patients will be enrolled and be randomized to either the Control Arm or to the Asymptomatic Screening Arm. Patients in the Control Arm will be followed by their primary care physicians with the recommendation that they follow standard guidelines for management of diabetic patients.

Patients in the Asymptomatic Screening Arm will undergo CT screening for either coronary calcium scoring or multi-slice CT angiography as well as be placed on one of two medical regimens. Patients will be followed by telephone at six-month intervals for two years for both primary and secondary outcomes.


Condition Intervention
Coronary Artery Disease
Procedure: CT Angiography

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Screening For Asymptomatic Obstructive Coronary Artery Disease Among High-Risk Diabetic Patients Using CT Angiography, Following Core 64: A Randomized Control Study (The faCTor-64 Study)

Resource links provided by NLM:


Further study details as provided by Intermountain Health Care, Inc.:

Primary Outcome Measures:
  • The combination of all cause death, non-fatal MI, and hospitalization for unstable angina. [ Time Frame: 2-years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1. CV death 2. Hospitalization for heart failure 3. Worsening renal failure (progression of serum creatinine by ≥0.5 mg/dL 4. Stroke or carotid revascularization procedure 5. Limb amputation or peripheral vascular disease [ Time Frame: 2-years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1100
Study Start Date: June 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Standard of Care
2
CT Angiography
Procedure: CT Angiography
If results indicate blockage, patients will receive interventional assessment (i.e., angiography) and treatment if indicated. All patients will receive aggressive treatment for type II diabetes (hemoglobin A1C) and lipids.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age: Males ≥ 50 years; Females ≥55 years with: History of diabetes mellitus (prior documentation of fasting glucose ≥ 126 mg/dl or hemoglobin A1C > 6.5%), either type 1 or type 2, documented for at least 3 years and on medication for at least one year.
  2. Age: Males ≥ 40 years; Females ≥45 years with: History of diabetes mellitus (prior documentation of fasting glucose ≥ 126 mg/dl or hemoglobin A1C > 6.5%), either type 1 or type 2, documented for at least 5 years and on medication for at least one year.
  3. The patient or legally authorized representative must sign a written informed consent, prior to the procedure, using a form that is approved by the local Institutional Review Board.

Exclusion Criteria:

  1. Known coronary artery disease (stenosis >70%, history of myocardial infarction, or angina)
  2. Symptomatic cerebral vascular disease (history of TIA, CVA, or cerebrovascular [carotid or cerebral arteries] revascularization)
  3. Symptomatic peripheral vascular disease (history of claudication, amputation, or peripheral [including renal arteries] arterial revascularization)
  4. Treatment with any other investigational drug within the previous 30 days
  5. Any therapy or condition that would pose a risk to the patient or make it difficult to comply with study requirements.
  6. Pregnant and/or lactating women, and women of child bearing potential not using acceptable means of contraception. Women of childbearing potential must be using adequate measures of contraception (as determined by the Investigator) to avoid pregnancy and should be highly unlikely to conceive during the study period. Women of childbearing potential must have a negative pregnancy test at screen.
  7. Any life threatening condition/significant co-morbidity such that primary screening is inappropriate.

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  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00488033

Locations
United States, Utah
Intermountain Healthcare
Salt Lake City, Utah, United States, 84143
Sponsors and Collaborators
Intermountain Health Care, Inc.
Deseret Foundation
Toshiba America Medical Systems, Inc.
Investigators
Principal Investigator: Joseph B Muhlestein, MD Intermountain Health Care, Inc.
  More Information

No publications provided

Responsible Party: Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT00488033     History of Changes
Other Study ID Numbers: 128-026
Study First Received: June 15, 2007
Last Updated: August 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Intermountain Health Care, Inc.:
Coronary Artery Disease
Diabetes
CT Angiography

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014