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

NCT00488033 | Completed Results DMC

• 1 other identifier: 128-026
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

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 a minimum of one year for both primary and secondary outcomes.

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease; Diabetes; CT Angiography

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Combination of All Cause Death, Non-fatal Myocardial Infarction (MI), and Hospitalization for Unstable Angina

  4 years

Secondary Outcomes (5)

• Number of Participants Suffering Cardiovascular (CV) Death

  4 years

• Number of Participants With Combination of Coronary Death, Non-fatal MI, and Unstable Angina With Hospitalization

  4 years

• Number of Participants With Hospitalization for Heart Failure

  4 years

• Number of Participants With Stroke or Carotid Revascularization Procedure

  4 years

• Number of Participants With Limb Amputation or Peripheral Vascular Revascularization Procedure

  4 years

Study Arms (2)

1

NO INTERVENTION

Standard of Care

2

OTHER

CT Angiography

Procedure: CT Angiography

Interventions

CT Angiography PROCEDURE

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.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• Known coronary artery disease (stenosis \>70%, history of myocardial infarction, or angina)
• Symptomatic cerebral vascular disease (history of TIA, CVA, or cerebrovascular \[carotid or cerebral arteries\] revascularization)
• Symptomatic peripheral vascular disease (history of claudication, amputation, or peripheral \[including renal arteries\] arterial revascularization)
• Treatment with any other investigational drug within the previous 30 days
• Any therapy or condition that would pose a risk to the patient or make it difficult to comply with study requirements.
• 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.
• Any life threatening condition/significant co-morbidity such that primary screening is inappropriate.

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead
• Deseret Foundation: collaborator
• Toshiba America Medical Systems, Inc.: collaborator

Study Sites (1)

Intermountain Healthcare

Salt Lake City, Utah, 84143, United States

Location

Related Publications (2)

• Muhlestein JB, Lappe DL, Lima JA, Rosen BD, May HT, Knight S, Bluemke DA, Towner SR, Le V, Bair TL, Vavere AL, Anderson JL. Effect of screening for coronary artery disease using CT angiography on mortality and cardiac events in high-risk patients with diabetes: the FACTOR-64 randomized clinical trial. JAMA. 2014 Dec 3;312(21):2234-43. doi: 10.1001/jama.2014.15825.

  PMID: 25402757 DERIVED

• Kwan AC, May HT, Cater G, Sibley CT, Rosen BD, Lima JA, Rodriguez K, Lappe DL, Muhlestein JB, Anderson JL, Bluemke DA. Coronary artery plaque volume and obesity in patients with diabetes: the factor-64 study. Radiology. 2014 Sep;272(3):690-9. doi: 10.1148/radiol.14140611. Epub 2014 Apr 22.

  PMID: 24754493 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: J.Brent Muhlestein
• Organization: Intermountain Heart Institute

jbrent.muhlestein@imail.org

8015074702

Study Officials

• Joseph B Muhlestein, MD

  Intermountain Health Care, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2007
• First Posted: June 19, 2007
• Study Start: June 1, 2007
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: March 15, 2017
• Results First Posted: March 15, 2017

Record last verified: 2014-09

Locations

US (1)