Trial Outcomes & Findings for Screening For Asymptomatic Obstructive Coronary Artery Disease Among High-Risk Diabetic Patients Using CT Angiography, Following Core 64 (NCT NCT00488033)
NCT ID: NCT00488033
Last Updated: 2017-03-15
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
900 participants
Primary outcome timeframe
4 years
Results posted on
2017-03-15
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
448
|
452
|
|
Overall Study
COMPLETED
|
447
|
452
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Hemoglobin A1C information was unavailable for 40 participants.
Baseline characteristics by cohort
| Measure |
Standard of Care
n=447 Participants
Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
|
Coronary Computed Tomographic Angiography
n=452 Participants
Received medical management recommendations based on the results of their CT scans.
|
Total
n=899 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.6 years
STANDARD_DEVIATION 8.35 • n=447 Participants
|
61.5 years
STANDARD_DEVIATION 7.94 • n=452 Participants
|
61.5 years
STANDARD_DEVIATION 8.14 • n=899 Participants
|
|
Sex: Female, Male
Female
|
212 Participants
n=447 Participants
|
218 Participants
n=452 Participants
|
430 Participants
n=899 Participants
|
|
Sex: Female, Male
Male
|
235 Participants
n=447 Participants
|
234 Participants
n=452 Participants
|
469 Participants
n=899 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
427 Participants
n=447 Participants
|
434 Participants
n=452 Participants
|
861 Participants
n=899 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
13 Participants
n=447 Participants
|
10 Participants
n=452 Participants
|
23 Participants
n=899 Participants
|
|
Race/Ethnicity, Customized
African American
|
1 Participants
n=447 Participants
|
2 Participants
n=452 Participants
|
3 Participants
n=899 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=447 Participants
|
2 Participants
n=452 Participants
|
5 Participants
n=899 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
1 Participants
n=447 Participants
|
3 Participants
n=452 Participants
|
4 Participants
n=899 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=447 Participants
|
1 Participants
n=452 Participants
|
3 Participants
n=899 Participants
|
|
Body Mass Index (BMI)
|
33.4 kg/m^2
STANDARD_DEVIATION 7.05 • n=447 Participants
|
32.9 kg/m^2
STANDARD_DEVIATION 6.76 • n=452 Participants
|
33.1 kg/m^2
STANDARD_DEVIATION 6.90 • n=899 Participants
|
|
Smoking History or Current
|
68 Participants
n=447 Participants
|
75 Participants
n=452 Participants
|
143 Participants
n=899 Participants
|
|
Diabetes Mellitus
|
13.5 years
STANDARD_DEVIATION 10.72 • n=447 Participants
|
12.3 years
STANDARD_DEVIATION 9.23 • n=452 Participants
|
12.9 years
STANDARD_DEVIATION 10.01 • n=899 Participants
|
|
Diabetes Mellitus Type
Type I
|
52 Participants
n=447 Participants
|
56 Participants
n=452 Participants
|
108 Participants
n=899 Participants
|
|
Diabetes Mellitus Type
Type II
|
395 Participants
n=447 Participants
|
396 Participants
n=452 Participants
|
791 Participants
n=899 Participants
|
|
Diabetes Mellitus Medications
Non-Insulin Agent Only
|
255 Participants
n=447 Participants
|
258 Participants
n=452 Participants
|
513 Participants
n=899 Participants
|
|
Diabetes Mellitus Medications
Insulin Only
|
95 Participants
n=447 Participants
|
84 Participants
n=452 Participants
|
179 Participants
n=899 Participants
|
|
Diabetes Mellitus Medications
Both Non-Insulin Agent and Insulin
|
97 Participants
n=447 Participants
|
110 Participants
n=452 Participants
|
207 Participants
n=899 Participants
|
|
Hemoglobin A1C
|
7.5 percentage
STANDARD_DEVIATION 1.41 • n=447 Participants
|
7.4 percentage
STANDARD_DEVIATION 1.40 • n=452 Participants
|
7.5 percentage
STANDARD_DEVIATION 1.41 • n=899 Participants
|
|
Hemoglobin A1C Category
≤ 6.5
|
101 Participants
n=431 Participants • Hemoglobin A1C information was unavailable for 40 participants.
|
120 Participants
n=428 Participants • Hemoglobin A1C information was unavailable for 40 participants.
|
221 Participants
n=859 Participants • Hemoglobin A1C information was unavailable for 40 participants.
|
|
Hemoglobin A1C Category
6.5-8.0
|
225 Participants
n=431 Participants • Hemoglobin A1C information was unavailable for 40 participants.
|
210 Participants
n=428 Participants • Hemoglobin A1C information was unavailable for 40 participants.
|
435 Participants
n=859 Participants • Hemoglobin A1C information was unavailable for 40 participants.
|
|
Hemoglobin A1C Category
>8.0
|
105 Participants
n=431 Participants • Hemoglobin A1C information was unavailable for 40 participants.
|
98 Participants
n=428 Participants • Hemoglobin A1C information was unavailable for 40 participants.
|
203 Participants
n=859 Participants • Hemoglobin A1C information was unavailable for 40 participants.
|
|
Family History of Diabetes Mellitus
|
59 Participants
n=447 Participants
|
44 Participants
n=452 Participants
|
103 Participants
n=899 Participants
|
|
Family History of Cardiovascular Disease
|
88 Participants
n=447 Participants
|
69 Participants
n=452 Participants
|
157 Participants
n=899 Participants
|
|
Hypertension
|
308 Participants
n=447 Participants
|
287 Participants
n=452 Participants
|
595 Participants
n=899 Participants
|
|
Hyperlipidemia
|
282 Participants
n=447 Participants
|
285 Participants
n=452 Participants
|
567 Participants
n=899 Participants
|
|
Hypothyroidism/Hyperthyroidism
|
104 Participants
n=447 Participants
|
104 Participants
n=452 Participants
|
208 Participants
n=899 Participants
|
|
Depression
|
58 Participants
n=447 Participants
|
59 Participants
n=452 Participants
|
117 Participants
n=899 Participants
|
|
Gastroesophageal Reflux DIsease
|
98 Participants
n=447 Participants
|
92 Participants
n=452 Participants
|
190 Participants
n=899 Participants
|
|
Sleep Apnea
|
115 Participants
n=447 Participants
|
121 Participants
n=452 Participants
|
236 Participants
n=899 Participants
|
|
Asthma
|
48 Participants
n=447 Participants
|
45 Participants
n=452 Participants
|
93 Participants
n=899 Participants
|
|
Arthritis
|
11 Participants
n=447 Participants
|
8 Participants
n=452 Participants
|
19 Participants
n=899 Participants
|
|
Renal DIsease
|
32 Participants
n=447 Participants
|
33 Participants
n=452 Participants
|
65 Participants
n=899 Participants
|
|
Blood Pressure
Systolic
|
130.5 mmHg
STANDARD_DEVIATION 11.49 • n=447 Participants
|
129.1 mmHg
STANDARD_DEVIATION 12.45 • n=452 Participants
|
129.8 mmHg
STANDARD_DEVIATION 12.00 • n=899 Participants
|
|
Blood Pressure
Diastolic
|
74.1 mmHg
STANDARD_DEVIATION 7.71 • n=447 Participants
|
74.2 mmHg
STANDARD_DEVIATION 8.41 • n=452 Participants
|
74.1 mmHg
STANDARD_DEVIATION 8.06 • n=899 Participants
|
|
Statin Use
|
322 Participants
n=447 Participants
|
346 Participants
n=452 Participants
|
668 Participants
n=899 Participants
|
|
Fasting Lipid Panel
LDL cholesterol
|
87.7 mg/dL
STANDARD_DEVIATION 32.92 • n=447 Participants
|
86.3 mg/dL
STANDARD_DEVIATION 29.12 • n=452 Participants
|
87.0 mg/dL
STANDARD_DEVIATION 31.07 • n=899 Participants
|
|
Fasting Lipid Panel
HDL cholesterol
|
45.3 mg/dL
STANDARD_DEVIATION 13.41 • n=447 Participants
|
45.4 mg/dL
STANDARD_DEVIATION 14.04 • n=452 Participants
|
45.3 mg/dL
STANDARD_DEVIATION 13.72 • n=899 Participants
|
|
Fasting Triglycerides
|
132 mg/dL
n=447 Participants
|
144 mg/dL
n=452 Participants
|
139 mg/dL
n=899 Participants
|
|
LDL Cholesterol Categories
≤70
|
124 Participants
n=409 Participants • LDL category was unavailable for 82 participants.
|
123 Participants
n=408 Participants • LDL category was unavailable for 82 participants.
|
247 Participants
n=817 Participants • LDL category was unavailable for 82 participants.
|
|
LDL Cholesterol Categories
70-100
|
179 Participants
n=409 Participants • LDL category was unavailable for 82 participants.
|
169 Participants
n=408 Participants • LDL category was unavailable for 82 participants.
|
348 Participants
n=817 Participants • LDL category was unavailable for 82 participants.
|
|
LDL Cholesterol Categories
>100
|
106 Participants
n=409 Participants • LDL category was unavailable for 82 participants.
|
116 Participants
n=408 Participants • LDL category was unavailable for 82 participants.
|
222 Participants
n=817 Participants • LDL category was unavailable for 82 participants.
|
|
Creatinine
|
0.92 mg/dL
n=447 Participants
|
0.91 mg/dL
n=452 Participants
|
0.91 mg/dL
n=899 Participants
|
PRIMARY outcome
Timeframe: 4 yearsOutcome measures
| Measure |
Standard of Care
n=447 Participants
Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
|
Coronary Computed Tomographic Angiography
n=452 Participants
Received medical management recommendations based on the results of their CT scans.
|
|---|---|---|
|
Number of Participants With Combination of All Cause Death, Non-fatal Myocardial Infarction (MI), and Hospitalization for Unstable Angina
|
34 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: 4 yearsOutcome measures
| Measure |
Standard of Care
n=447 Participants
Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
|
Coronary Computed Tomographic Angiography
n=452 Participants
Received medical management recommendations based on the results of their CT scans.
|
|---|---|---|
|
Number of Participants Suffering Cardiovascular (CV) Death
|
8 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 4 yearsOutcome measures
| Measure |
Standard of Care
n=447 Participants
Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
|
Coronary Computed Tomographic Angiography
n=452 Participants
Received medical management recommendations based on the results of their CT scans.
|
|---|---|---|
|
Number of Participants With Combination of Coronary Death, Non-fatal MI, and Unstable Angina With Hospitalization
|
23 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: 4 yearsOutcome measures
| Measure |
Standard of Care
n=447 Participants
Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
|
Coronary Computed Tomographic Angiography
n=452 Participants
Received medical management recommendations based on the results of their CT scans.
|
|---|---|---|
|
Number of Participants With Hospitalization for Heart Failure
|
10 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 4 yearsOutcome measures
| Measure |
Standard of Care
n=447 Participants
Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
|
Coronary Computed Tomographic Angiography
n=452 Participants
Received medical management recommendations based on the results of their CT scans.
|
|---|---|---|
|
Number of Participants With Stroke or Carotid Revascularization Procedure
|
9 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 4 yearsOutcome measures
| Measure |
Standard of Care
n=447 Participants
Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
|
Coronary Computed Tomographic Angiography
n=452 Participants
Received medical management recommendations based on the results of their CT scans.
|
|---|---|---|
|
Number of Participants With Limb Amputation or Peripheral Vascular Revascularization Procedure
|
0 Participants
|
2 Participants
|
Adverse Events
Standard of Care
Serious events: 28 serious events
Other events: 0 other events
Deaths: 19 deaths
Coronary Computed Tomographic Angiography
Serious events: 29 serious events
Other events: 0 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Standard of Care
n=447 participants at risk
Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
|
Coronary Computed Tomographic Angiography
n=452 participants at risk
Received medical management recommendations based on the results of their CT scans.
|
|---|---|---|
|
Cardiac disorders
Non-Fatal MI
|
1.8%
8/447 • Number of events 8 • 2-7 years (mean 4 years)
|
1.5%
7/452 • Number of events 7 • 2-7 years (mean 4 years)
|
|
Cardiac disorders
Hospitalization for Unstable Angina
|
2.0%
9/447 • Number of events 9 • 2-7 years (mean 4 years)
|
2.0%
9/452 • Number of events 9 • 2-7 years (mean 4 years)
|
|
Cardiac disorders
Hospitalization for Heart Failure
|
2.2%
10/447 • Number of events 10 • 2-7 years (mean 4 years)
|
0.66%
3/452 • Number of events 3 • 2-7 years (mean 4 years)
|
|
Vascular disorders
Stroke or Carotid Revascularization Procedure
|
2.0%
9/447 • Number of events 9 • 2-7 years (mean 4 years)
|
1.8%
8/452 • Number of events 8 • 2-7 years (mean 4 years)
|
|
Vascular disorders
Limb Amputation or Peripheral Vascular Revascularization Procedure
|
0.00%
0/447 • 2-7 years (mean 4 years)
|
0.44%
2/452 • Number of events 2 • 2-7 years (mean 4 years)
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place