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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00488033
First Posted: June 19, 2007
Last Update Posted: March 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Deseret Foundation
Toshiba America Medical Systems, Inc.
Information provided by (Responsible Party):
Intermountain Health Care, Inc.
Results First Submitted: December 9, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Coronary Artery Disease
Intervention: Procedure: CT Angiography

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Standard of Care Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
Coronary Computed Tomographic Angiography Received medical management recommendations based on the results of their CT scans.

Participant Flow:   Overall Study
    Standard of Care   Coronary Computed Tomographic Angiography
STARTED   448   452 
COMPLETED   447   452 
NOT COMPLETED   1   0 
Withdrawal by Subject                1                0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Standard of Care Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
Coronary Computed Tomographic Angiography Received medical management recommendations based on the results of their CT scans.
Total Total of all reporting groups

Baseline Measures
   Standard of Care   Coronary Computed Tomographic Angiography   Total 
Overall Participants Analyzed 
[Units: Participants]
 447   452   899 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 447   452   899 
   61.6  (8.35)   61.5  (7.94)   61.5  (8.14) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 447   452   899 
Female      212  47.4%      218  48.2%      430  47.8% 
Male      235  52.6%      234  51.8%      469  52.2% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
White Non-Hispanic       
Participants Analyzed 
[Units: Participants]
 447   452   899 
White Non-Hispanic   427   434   861 
Hispanic       
Participants Analyzed 
[Units: Participants]
 447   452   899 
Hispanic   13   10   23 
African American       
Participants Analyzed 
[Units: Participants]
 447   452   899 
African American   1   2   3 
Asian       
Participants Analyzed 
[Units: Participants]
 447   452   899 
Asian   3   2   5 
American Indian       
Participants Analyzed 
[Units: Participants]
 447   452   899 
American Indian   1   3   4 
Native Hawaiian or Other Pacific Islander       
Participants Analyzed 
[Units: Participants]
 447   452   899 
Native Hawaiian or Other Pacific Islander   2   1   3 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 447   452   899 
   33.4  (7.05)   32.9  (6.76)   33.1  (6.90) 
Smoking History or Current 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 447   452   899 
   68   75   143 
Diabetes Mellitus 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 447   452   899 
   13.5  (10.72)   12.3  (9.23)   12.9  (10.01) 
Diabetes Mellitus Type 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 447   452   899 
Type I      52  11.6%      56  12.4%      108  12.0% 
Type II      395  88.4%      396  87.6%      791  88.0% 
Diabetes Mellitus Medications 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 447   452   899 
Non-Insulin Agent Only      255  57.0%      258  57.1%      513  57.1% 
Insulin Only      95  21.3%      84  18.6%      179  19.9% 
Both Non-Insulin Agent and Insulin      97  21.7%      110  24.3%      207  23.0% 
Hemoglobin A1C 
[Units: Percentage]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 447   452   899 
   7.5  (1.41)   7.4  (1.40)   7.5  (1.41) 
Hemoglobin A1C Category [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 431   428   859 
≤ 6.5      101  23.4%      120  28.0%      221  25.7% 
6.5-8.0      225  52.2%      210  49.1%      435  50.6% 
>8.0      105  24.4%      98  22.9%      203  23.6% 
[1] Hemoglobin A1C information was unavailable for 40 participants.
Family History of Diabetes Mellitus 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 447   452   899 
   59   44   103 
Family History of Cardiovascular Disease 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 447   452   899 
   88   69   157 
Hypertension 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 447   452   899 
   308   287   595 
Hyperlipidemia 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 447   452   899 
   282   285   567 
Hypothyroidism/Hyperthyroidism 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 447   452   899 
   104   104   208 
Depression 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 447   452   899 
   58   59   117 
Gastroesophageal Reflux DIsease 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 447   452   899 
   98   92   190 
Sleep Apnea 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 447   452   899 
   115   121   236 
Asthma 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 447   452   899 
   48   45   93 
Arthritis 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 447   452   899 
   11   8   19 
Renal DIsease 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 447   452   899 
   32   33   65 
Blood Pressure 
[Units: mmHg]
Mean (Standard Deviation)
     
Systolic       
Participants Analyzed 
[Units: Participants]
 447   452   899 
Systolic   130.5  (11.49)   129.1  (12.45)   129.8  (12.00) 
Diastolic       
Participants Analyzed 
[Units: Participants]
 447   452   899 
Diastolic   74.1  (7.71)   74.2  (8.41)   74.1  (8.06) 
Statin Use 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 447   452   899 
   322   346   668 
Fasting Lipid Panel 
[Units: mg/dL]
Mean (Standard Deviation)
     
LDL cholesterol       
Participants Analyzed 
[Units: Participants]
 447   452   899 
LDL cholesterol   87.7  (32.92)   86.3  (29.12)   87.0  (31.07) 
HDL cholesterol       
Participants Analyzed 
[Units: Participants]
 447   452   899 
HDL cholesterol   45.3  (13.41)   45.4  (14.04)   45.3  (13.72) 
Fasting Triglycerides 
[Units: mg/dL]
Median (Inter-Quartile Range)
     
Participants Analyzed 
[Units: Participants]
 447   452   899 
   132 
 (92 to 198) 
 144 
 (99 to 201) 
 139 
 (96 to 200) 
LDL Cholesterol Categories [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 409   408   817 
≤70      124  30.3%      123  30.1%      247  30.2% 
70-100      179  43.8%      169  41.4%      348  42.6% 
>100      106  25.9%      116  28.4%      222  27.2% 
[1] LDL category was unavailable for 82 participants.
Creatinine 
[Units: mg/dL]
Median (Inter-Quartile Range)
     
Participants Analyzed 
[Units: Participants]
 447   452   899 
   0.92 
 (0.80 to 1.10) 
 0.91 
 (0.79 to 1.10) 
 0.91 
 (0.80 to 1.10) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Combination of All Cause Death, Non-fatal Myocardial Infarction (MI), and Hospitalization for Unstable Angina   [ Time Frame: 4 years ]

2.  Secondary:   Number of Participants Suffering Cardiovascular (CV) Death   [ Time Frame: 4 years ]

3.  Secondary:   Number of Participants With Combination of Coronary Death, Non-fatal MI, and Unstable Angina With Hospitalization   [ Time Frame: 4 years ]

4.  Secondary:   Number of Participants With Hospitalization for Heart Failure   [ Time Frame: 4 years ]

5.  Secondary:   Number of Participants With Stroke or Carotid Revascularization Procedure   [ Time Frame: 4 years ]

6.  Secondary:   Number of Participants With Limb Amputation or Peripheral Vascular Revascularization Procedure   [ Time Frame: 4 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: J.Brent Muhlestein
Organization: Intermountain Heart Institute
phone: 8015074702
e-mail: jbrent.muhlestein@imail.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT00488033     History of Changes
Other Study ID Numbers: 128-026
First Submitted: June 15, 2007
First Posted: June 19, 2007
Results First Submitted: December 9, 2016
Results First Posted: March 15, 2017
Last Update Posted: March 15, 2017