- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02942342
Evaluation of Asymptomatic Coronary Atherosclerotic Disease Among People of Kalamazoo, MI (ESCAPE MI)
August 28, 2020 updated by: Vishal Gupta, Borgess Research Institute
Evaluation of Asymptomatic Coronary Atherosclerotic Disease Among People of Kalamazoo County and Neighboring Areas in Michigan, Who Have Risk Factors of Coronary Artery Disease
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
240
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kathleen Gross, MD
- Phone Number: (269) 337-4327
- Email: kathleen.gross@med.wmich.edu
Study Locations
-
-
Michigan
-
Kalamazoo, Michigan, United States, 49080
- Recruiting
- Borgess Medical Center
-
Contact:
- Kathleen Gross, MD
- Phone Number: 269-337-4327
- Email: kathleen.gross@med.wmich.edu
-
Principal Investigator:
- Vishal Gupta, MD, MPH
-
Sub-Investigator:
- Azzam Kannan, MD
-
Sub-Investigator:
- Mark Shaman, MD
-
Sub-Investigator:
- Marcio Curvello, MD
-
Sub-Investigator:
- John Hopkins, MD
-
Sub-Investigator:
- Ronald Zegerius, MD
-
Sub-Investigator:
- Jesse Duranceau, MD
-
Sub-Investigator:
- Anna Langerveld, PhD
-
Sub-Investigator:
- James Springstead, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 55 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Estimation of the proportion of people in the Kalamazoo, MI, area who have asymptomatic CAD.
Time Frame: 3 years
|
3 years
|
Compare evidence of atherosclerosis or calcification, as evidenced by CT scan, to associated biomarker values.
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Vishal Gupta, MD, MPH, Borgess Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2016
Primary Completion (Anticipated)
January 1, 2022
Study Completion (Anticipated)
March 1, 2022
Study Registration Dates
First Submitted
March 31, 2016
First Submitted That Met QC Criteria
October 21, 2016
First Posted (Estimate)
October 24, 2016
Study Record Updates
Last Update Posted (Actual)
September 1, 2020
Last Update Submitted That Met QC Criteria
August 28, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-2466
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronary Artery Disease
-
Elixir Medical CorporationIstituto Clinico HumanitasActive, not recruitingCoronary Artery Disease | Chronic Total Occlusion of Coronary Artery | Multi Vessel Coronary Artery Disease | Bifurcation of Coronary Artery | Long Lesions Coronary Artery DiseaseItaly
-
Fundación EPICActive, not recruitingCoronary Artery Disease | Left Main Coronary Artery Disease | Left Main Coronary Artery Stenosis | Restenosis, CoronarySpain
-
Peking Union Medical College HospitalNot yet recruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
Peking Union Medical College HospitalRecruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
IGLESIAS Juan FernandoUniversity of BernNot yet recruiting
-
National Institutes of Health Clinical Center (CC)National Heart, Lung, and Blood Institute (NHLBI)CompletedCoronary Arteriosclerosis | Coronary Artery Disease (CAD) | Obstructive Coronary Artery DiseaseUnited States
-
Barts & The London NHS TrustImperial College London; Brunel UniversityNot yet recruitingCORONARY ARTERY DISEASE
-
Fundación EPICRecruitingCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Left Main Coronary Artery Disease | Coronary Artery StenosisSpain
-
Abbott Medical DevicesCompletedCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Chronic Total Occlusion of Coronary Artery | Coronary Restenosis | Coronary Artery Stenosis | Coronary Artery RestenosisBelgium
-
China National Center for Cardiovascular DiseasesRecruitingLeft Main Coronary Artery DiseaseChina
Clinical Trials on Computed Tomography (CT) Scan
-
University of RochesterNational Cancer Institute (NCI)Completed
-
Dana-Farber Cancer InstituteBrigham and Women's HospitalCompletedLung CancerUnited States
-
H. Lee Moffitt Cancer Center and Research InstituteCompleted
-
M.D. Anderson Cancer CenterCompletedProstate CancerUnited States
-
UMC UtrechtZonMw: The Netherlands Organisation for Health Research and DevelopmentTerminatedStroke | Disorder; Heart, Functional, Postoperative, Cardiac Surgery | Cardiac DefectsNetherlands, Hungary
-
University of MiamiNational Cancer Institute (NCI)CompletedHead and Neck Cancer | Lung Cancer | Prostate CancerUnited States
-
M.D. Anderson Cancer CenterGE HealthcareCompletedLung CancerUnited States
-
ECRI bvGE Healthcare; HeartFlow, Inc.CompletedHeart Diseases | Cardiovascular Diseases | Multivessel Coronary Artery Disease | Coronary Artery DiseasesBelgium, France, Germany, Italy, Switzerland
-
Sidney Kimmel Cancer Center at Thomas Jefferson...TerminatedOral Cavity Squamous Cell Carcinoma
-
FLUIDDA nvCompletedInfluence of Mouthpiece Design on Upper Airway GeometryBelgium