Coronary Artery DiseaseESCAPE MINCT02942342
Evaluation of Asymptomatic Coronary Atherosclerotic Disease Among People of Kalamazoo, MI
A study testing Computed Tomography (CT) Scan in people with Coronary Artery Disease and Atherosclerosis, run by Borgess Research Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 55 years
- Conditions the study is for
- Coronary Artery Disease, Atherosclerosis
- What is being tested?
- Computed Tomography (CT) Scan
- Type of treatment
- Surgery or procedure
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Borgess Medical Center
Kalamazoo, Michigan, 49080
Kathleen Gross, MD, 269-337-4327, kathleen.gross@med.wmich.edu
Vishal Gupta, MD, MPH
About this study
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
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.
- Conditions
- Coronary Artery Disease, Atherosclerosis
- Being tested
- Computed Tomography (CT) Scan
- Medical subject headings
- Coronary Artery Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed Tomography (CT) ScanProcedure or surgery
CT Scans will be used as a diagnostic tool for asymptomatic CAD.
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of the proportion of people in the Kalamazoo, MI, area who have asymptomatic CAD.
Measured: 3 years
Compare evidence of atherosclerosis or calcification, as evidenced by CT scan, to associated biomarker values.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study startMar 2016
- Primary completionJan 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Borgess Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vishal Gupta, Borgess Research Institute
- Investigators
- Vishal Gupta, MD, MPH, Principal investigator, Borgess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942342
- Sponsor's protocol ID
- 2015-2466
- Acronym
- ESCAPE MI
- Status last verified
- Aug 2020
- First submitted
- 31 Mar 2016
- Last updated
- 1 Sep 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02942342
- Acronym / sponsor ID
- ESCAPE MI / 2015-2466
- Conditions
- Coronary Artery Disease, Atherosclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Borgess Research InstituteUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 24 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed Tomography (CT) ScanCT Scans will be used as a diagnostic tool for asymptomatic CAD. | Procedure or surgery | – |
Primary outcome
Estimation of the proportion of people in the Kalamazoo, MI, area who have asymptomatic CAD.
Time frame: 3 years
Compare evidence of atherosclerosis or calcification, as evidenced by CT scan, to associated biomarker values.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vishal Gupta, MD, MPH principal investigator
Borgess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computed Tomography (CT) Scan in people with Coronary Artery Disease and Atherosclerosis, run by Borgess Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kathleen Gross, MD ((269) 337-4327, kathleen.gross@med.wmich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimation of the proportion of people in the Kalamazoo, MI, area who have asymptomatic CAD. (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2020.