Evaluation of Asymptomatic Coronary Atherosclerotic Disease Among People of Kalamazoo, MI
ESCAPE MI
1 other identifier
interventional
240
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable coronary-artery-disease
Started Mar 2016
Longer than P75 for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 31, 2016
CompletedFirst Posted
Study publicly available on registry
October 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedSeptember 1, 2020
August 1, 2020
5.8 years
March 31, 2016
August 28, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Estimation of the proportion of people in the Kalamazoo, MI, area who have asymptomatic CAD.
3 years
Compare evidence of atherosclerosis or calcification, as evidenced by CT scan, to associated biomarker values.
3 years
Interventions
CT Scans will be used as a diagnostic tool for asymptomatic CAD.
Eligibility Criteria
You may qualify if:
- Subject is between 35 and 55 years of age.
- Subject receives care in Kalamazoo County and neighboring areas.
- No known history of coronary artery disease, peripheral vascular disease or stroke.
- Asymptomatic per shortened World Health Organization (WHO) Rose Angina Questionnaire.
- Any one of the following sets of clinical risk factors for CAD:
- Premature Immediate Family History of CAD (Male \<55 years old, Female \<65 years old)
- Diabetes Mellitus Type 2
- Chronic Smoker (currently smoking at least 1 cigarette per month)
- Any family history of CAD with Dyslipidemia or hypertension or former smoker
- Stress test or cardiac catheterization procedure is not clinically indicated for the subject at the time of enrollment.
- Subject has signed informed consent.
You may not qualify if:
- Subject has known coronary artery disease.
- Known abnormal stress test where coronary angiography is indicated.
- 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).
- Subject reports they have active systemic or cutaneous infection or inflammation (e.g., septicemia at the time of the procedure).
- Subject has uncontrolled hypertension (\> 180 mmHg systolic and \>110mmHg diastolic).
- Subject presents with hemodynamic instability or is in need of emergent surgery.
- Known contraindications or known severe reaction to iodinated contrast media.
- Known contraindications to beta-blockers.
- Known contraindications to use of sublingual nitroglycerine.
- Subject has history of chronic kidney disease, with a Glomerular Filtration Rate (GFR) of 45 or below.
- Subject has known history of Non-Ischemic Cardiomyopathy (NICMP)
- Subject has a pre-existing severe systemic disease or illness that results in an expected life expectancy of less than 2 years.
- Subject is currently participating in an investigational drug or another device study that clinically interferes with the current study endpoints.
- Pregnant or lactating subjects.
- Known arrhythmias that does not allow electrocardiogram (ECG) triggering, as determined at the time of CT scan. ECG prior to procedure is not indicated.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Borgess Medical Center
Kalamazoo, Michigan, 49080, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vishal Gupta, MD, MPH
Borgess Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Director, Cardiac Catheterization Laboratory
Study Record Dates
First Submitted
March 31, 2016
First Posted
October 24, 2016
Study Start
March 1, 2016
Primary Completion
January 1, 2022
Study Completion
March 1, 2022
Last Updated
September 1, 2020
Record last verified: 2020-08