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

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Screening For Asymptomatic Obstructive Coronary Artery Disease Among High-Risk Diabetic Patients Using CT Angiography, Following Core 64 (faCTor-64)
This study is currently recruiting participants.
Verified by Intermountain Health Care, Inc., May 2007
Sponsors and Collaborators: Intermountain Health Care, Inc.
Deseret Foundation
Toshiba

Information provided by: Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT00488033

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

MedlinePlus related topics: Coronary Artery Disease
U.S. FDA Resources
Study Type:Interventional
Study Design:Prevention, Randomized, Open Label, Uncontrolled, Factorial Assignment, Efficacy Study
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)

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 2011
Estimated Primary Completion Date:June 2011 (Final data collection date for primary outcome measure)


Arms Assigned Interventions
1: No Intervention
Standard of Care
2
CT Angiography Procedure: CT Angiography

Detailed Description:
Management of Patients Randomized to the Control Arm: Subjects randomized to the control arm will continue to be followed by their primary care physicians with the recommendation that they follow standard guidelines for management of diabetic patients.

Management of Patients Randomized to the Asymptomatic Screening Arm: Subjects randomized to the Asymptomatic Screening arm will undergo initial CT screening in the following fashion:

Subjects with serum creatinine of < 2.0 mg/dl (men) or <1.8 mg/dL (women) will be screened using multi-slice CT angiography with contrast.
Those with serum creatinine &#8805; 2.0 mg/dl (men) or >1.8 mg/dL (women) will be screened without contrast to obtain a coronary calcium score. Further cardiac screening will be determined based on these results.
Subjects Receiving Multi-Slice CT Angiography (serum creatinine of < 2.0 mg/dl (men) or <1.8 mg/dL (women)): Subjects severe stenosis will proceed to coronary angiography and revascularization as needed. Subjects with moderate stenosis will be referred for adenosine stress cardiac MRI. If ischemia is detected, they will also be referred for coronary angiography. Subjects with either mild stenosis or normal coronary arteries will receive no further imaging studies.

Subjects Undergoing CT Evaluation for Coronary Calcium Scoring (serum creatinine &#8805; 2.0 mg/dl (men) or >1.8 mg/dL (women): Subjects with coronary calcium scores >100 or >75th percentile will be referred for adenosine stress cardiac MRI. If ischemia is detected, they will be referred for coronary angiography. Subjects with coronary calcium scores = 0-10 or 11-100 and <75th percentile will receive no further imaging studies.

Medical Management (Only for those patients randomized to the Asymptomatic Screening Arm): In addition to the imaging studies and potential coronary revascularization procedures performed as described above, all subjects will be placed on one of two medical regimens:

Standard Appropriate DM Care and
Aggressive Risk Factor Reduction Care.
Standard Appropriate DM Care: Subjects assigned to this form of medical care will be managed by their primary physicians. This type of care will consist of targeting the goals proposed by Intermountain Healthcare for all patients with diabetes. These include the following three targets: HgA1C <7.0%, LDL cholesterol <100 mg/dL and Systolic BP<130 mm Hg. Subjects assigned to Standard Care will include all control subjects, as well as all screened subjects with either a normal CT angiogram or a coronary calcium score = 0-10.

Aggressive Risk Factor Reduction Care: Subjects assigned to this form of medical care, in addition to standard medical care provided by their primary physicians, will also be managed by their primary physicians, but will receive more aggressive risk factor reduction management according to a set of guidelines that will be given to the primary physicians. This aggressive management strategy, designed to address the increased medical risk among the asymptomatic diabetics with detected vascular disease, will consist of more aggressive glucose and lipid targets than is in the Standard Care protocols and specific medication algorithms designed to accomplish these more aggressive targets.

Follow-Up After enrollment into the protocol, all subjects will be followed for two years. Follow-up will occur by telephone at six-month intervals. Outcomes will be ascertained by directly questioning the patient and by review of medical records. All primary outcomes will be adjudicated by an independent events committee. At 24 months, the SF-12 questionnaire will be mailed to all the participants to determine their physical and mental status.

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

History of diabetes mellitus (prior documentation of fasting glucose &#8805; 126 mg/dl or hemoglobin A1C > 6.5%), either type 1 or type 2, documented for at least five years and on medication for at least one year.
Age: Males &#8805; 50 years; Females &#8805;55 years
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:

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.
Contacts and Locations

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

Contacts
Contact: Joseph B Muhlestein, MD 801-408-5300 Brent.Muhlestein@intermountainmail.org
Contact: Jeffrey L Anderson, MD 801-408-5321 Jeffrey.Anderson@intermountainmail.org


Locations
United States, Utah
Intermountain Healthcare Recruiting
Salt Lake City, Utah, United States, 84143
Contact: Joseph B Muhlestein, MD 801-408-5300 Brent.Muhlestein@intermountainmail.org
Contact: Jeffrey L Anderson, MD 801-408-5321 Jeffrey.Anderson@intermountainmail.org
Sub-Investigator: Jeffrey L Anderson, MD
Sub-Investigator: Donald L Lappe, MD
Sub-Investigator: João AC Lima, MD
Sub-Investigator: Steven Towner, MD

Sponsors and Collaborators
Intermountain Health Care, Inc.
Deseret Foundation
Toshiba
Investigators
Principal Investigator: Joseph B Muhlestein, MD Intermountain Health Care, Inc.

Responsible Party:Intermountain Health Care ( J. Brent Muhlestein )
Study ID Numbers:128-026
First Received:June 15, 2007
Last Updated:May 12, 2008
ClinicalTrials.gov Identifier:NCT00488033 [history]
Health Authority:United States: Institutional Review Board

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

Study placed in the following topic categories:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Diabetes Mellitus
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:
Cardiovascular Diseases