Clinical trial NCT02942342: Evaluation of Asymptomatic Coronary Atherosclerotic Disease Among People of Kalamazoo, MI
Official title: Evaluation of Asymptomatic Coronary Atherosclerotic Disease Among People of Kalamazoo County and Neighboring Areas in Michigan, Who Have Risk Factors of Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Atherosclerosis
Lead sponsor: Borgess Research Institute
Sponsor class: OTHER
First posted: 2016-10-24
Enrollment: 240
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary goal of this study is to determine the prevalence of undiagnosed asymptomatic coronary artery disease (CAD) in Kalamazoo and its neighboring areas using Coronary Computed Tomography (CCTA) and Coronary Artery Calcium Score (CACS) to assess if asymptomatic CAD is widespread enough to warrant implementation of CCTA as a routine screening tool. Additionally, this study will use the CCTA results to evaluate several methods of assessing CAD risk in the asymptomatic population including Framingham Risk Score (FRS) and Reynold's Risk Score, Biomarkers (High sensitivity C-Reactive Protein, Fibrinogen, Vertical Auto Profile, oxidized Low Density Lipoprotein (LDL), Apolipoprotein A1 (ApoA1), Apolipoprotein B1 (ApoB1), Vitamin D, Homocysteine) as well as a large panel of genetic markers of atherosclerosis and dyslipidemia.


Eligibility criteria: Inclusion Criteria:

1. Subject is between 35 and 55 years of age.
2. Subject receives care in Kalamazoo County and neighboring areas.
3. No known history of coronary artery disease, peripheral vascular disease or stroke.
4. Asymptomatic per shortened World Health Organization (WHO) Rose Angina Questionnaire.
5. Any one of the following sets of clinical risk factors for CAD:

   1. Premature Immediate Family History of CAD (Male \<55 years old, Female \<65 years old)
   2. Diabetes Mellitus Type 2
   3. Chronic Smoker (currently smoking at least 1 cigarette per month)
   4. Any family history of CAD with Dyslipidemia or hypertension or former smoker
6. Stress test or cardiac catheterization procedure is not clinically indicated for the subject at the time of enrollment.
7. Subject has signed informed consent.

Exclusion Criteria:

1. Subject has known coronary artery disease.
2. Known abnormal stress test where coronary angiography is indicated.
3. Subject is unable to routinely walk at least 20 feet without assistance (e.g., requires a walker or wheelchair to mobilize or has known paralysis).
4. Subject reports they have active systemic or cutaneous infection or inflammation (e.g., septicemia at the time of the procedure).
5. Subject has uncontrolled hypertension (\> 180 mmHg systolic and \>110mmHg diastolic).
6. Subject presents with hemodynamic instability or is in need of emergent surgery.
7. Known contraindications or known severe reaction to iodinated contrast media.
8. Known contraindications to beta-blockers.
9. Known contraindications to use of sublingual nitroglycerine.
10. Subject has history of chronic kidney disease, with a Glomerular Filtration Rate (GFR) of 45 or below.
11. Subject has known history of Non-Ischemic Cardiomyopathy (NICMP)
12. Subject has a pre-existing severe systemic disease or illness that results in an expected life expectancy of less than 2 years.
13. Subject is currently participating in an investigational drug or another device study that clinically interferes with the current study endpoints.
14. Pregnant or lactating subjects.
15. Known arrhythmias that does not allow electrocardiogram (ECG) triggering, as determined at the time of CT scan. ECG prior to procedure is not indicated.
16. History of a brain tumor; a recent (within the past 6 months) head or brain injury, concussion, epilepsy, or other seizure disorders, severe liver disease, sickle cell anemia, multiple sclerosis, substance abuse, multiple myeloma, pheochromocytoma, or a thyroid disorder.

Primary outcomes:
measure: Estimation of the proportion of people in the Kalamazoo, MI, area who have asymptomatic CAD.
timeFrame: 3 years
measure: Compare evidence of atherosclerosis or calcification, as evidenced by CT scan, to associated biomarker values.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kalamazoo
country: United States
facility: Borgess Medical Center
state: Michigan
Study officials:
affiliation: Borgess Medical Center
name: Vishal Gupta, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: