Cardiovascular Diseases Clinical Trial
Official title:
The Assessment of Large and Small Artery Elasticity for the Early Detection of Cardiovascular Disease
Verified date | December 2020 |
Source | St. Boniface Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Efforts to identify individuals at a higher risk for adverse cardiovascular outcomes focus on traditional risk factors, such as age, gender, smoking status, blood pressure, and cholesterol; however, this approach does not directly assess cardiovascular function and underestimates the risk of experiencing adverse cardiovascular outcomes in women. This prospective, observational trial will examine the ability of the Assessment of Large and Small Artery Elasticity for the Early Detection of Cardiovascular Disease screening protocol, a series of non-invasive procedures to identify middle-aged and older women who are at elevated risk for experiencing an adverse cardiovascular event in the five-year period after screening. The predictive value of the Assessment of Large and Small Artery Elasticity for the Early Detection of Cardiovascular Disease protocol will also be compared to the Framingham Risk Score to determine if one method has better sensitivity for estimating risk for an adverse cardiovascular outcome.
Status | Active, not recruiting |
Enrollment | 1000 |
Est. completion date | February 2022 |
Est. primary completion date | February 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 55 Years and older |
Eligibility | Inclusion Criteria: - women aged 55 and older - possess a Manitoba Personal Health Information Number Exclusion Criteria: - previous hospitalization for: - ischemic heart disease - acute myocardial infarction - stroke - percutaneous coronary intervention - coronary artery bypass surgery - congestive heart failure - peripheral artery disease |
Country | Name | City | State |
---|---|---|---|
Canada | St-Boniface Hospital Albrechtsen Research Center | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
St. Boniface Hospital |
Canada,
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ischemic heart disease | Each individual's Personal Health Information Number (PHIN) will be utilized to follow the study participants and to determine if they experienced an adverse cardiovascular outcome using the Manitoba Centre for Health Policy (MCHP) Population Health Research Data Repository. Hospital separations abstracts, medical claims and the Drug Program Information Network will be examined to provide information on hospitalizations for cardiac diseases, cardiac procedures performed, cardiac-related and other medications used, and diagnoses with cardiac diseases. Vital statistics will also provide information on cause of death to allow for mortality rate tracking. This administrative health data will be used to compare adverse cardiovascular events with participants recruited under the current protocol to determine if our cardiovascular screening approach predicted which individuals were at moderate to high risk of an adverse cardiovascular outcome over the five-year period after screening. | 5 years post-screening | |
Primary | Acute myocardial infarction | Each individual's Personal Health Information Number (PHIN) will be utilized to follow the study participants and to determine if they experienced an adverse cardiovascular outcome using the Manitoba Centre for Health Policy (MCHP) Population Health Research Data Repository. Hospital separations abstracts, medical claims and the Drug Program Information Network will be examined to provide information on hospitalizations for cardiac diseases, cardiac procedures performed, cardiac-related and other medications used, and diagnoses with cardiac diseases. Vital statistics will also provide information on cause of death to allow for mortality rate tracking. This administrative health data will be used to compare adverse cardiovascular events with participants recruited under the current protocol to determine if our cardiovascular screening approach predicted which individuals were at moderate to high risk of an adverse cardiovascular outcome over the five-year period after screening. | 5 years post-screening | |
Primary | Stroke | Each individual's Personal Health Information Number (PHIN) will be utilized to follow the study participants and to determine if they experienced an adverse cardiovascular outcome using the Manitoba Centre for Health Policy (MCHP) Population Health Research Data Repository. Hospital separations abstracts, medical claims and the Drug Program Information Network will be examined to provide information on hospitalizations for cardiac diseases, cardiac procedures performed, cardiac-related and other medications used, and diagnoses with cardiac diseases. Vital statistics will also provide information on cause of death to allow for mortality rate tracking. This administrative health data will be used to compare adverse cardiovascular events with participants recruited under the current protocol to determine if our cardiovascular screening approach predicted which individuals were at moderate to high risk of an adverse cardiovascular outcome over the five-year period after screening. | 5 years post-screening | |
Primary | Percutaneous coronary intervention | Each individual's Personal Health Information Number (PHIN) will be utilized to follow the study participants and to determine if they experienced an adverse cardiovascular outcome using the Manitoba Centre for Health Policy (MCHP) Population Health Research Data Repository. Hospital separations abstracts, medical claims and the Drug Program Information Network will be examined to provide information on hospitalizations for cardiac diseases, cardiac procedures performed, cardiac-related and other medications used, and diagnoses with cardiac diseases. Vital statistics will also provide information on cause of death to allow for mortality rate tracking. This administrative health data will be used to compare adverse cardiovascular events with participants recruited under the current protocol to determine if our cardiovascular screening approach predicted which individuals were at moderate to high risk of an adverse cardiovascular outcome over the five-year period after screening. | 5 years post-screening | |
Primary | Coronary artery bypass surgery | Each individual's Personal Health Information Number (PHIN) will be utilized to follow the study participants and to determine if they experienced an adverse cardiovascular outcome using the Manitoba Centre for Health Policy (MCHP) Population Health Research Data Repository. Hospital separations abstracts, medical claims and the Drug Program Information Network will be examined to provide information on hospitalizations for cardiac diseases, cardiac procedures performed, cardiac-related and other medications used, and diagnoses with cardiac diseases. Vital statistics will also provide information on cause of death to allow for mortality rate tracking. This administrative health data will be used to compare adverse cardiovascular events with participants recruited under the current protocol to determine if our cardiovascular screening approach predicted which individuals were at moderate to high risk of an adverse cardiovascular outcome over the five-year period after screening. | 5 years post-screening | |
Primary | Congestive heart failure | Each individual's Personal Health Information Number (PHIN) will be utilized to follow the study participants and to determine if they experienced an adverse cardiovascular outcome using the Manitoba Centre for Health Policy (MCHP) Population Health Research Data Repository. Hospital separations abstracts, medical claims and the Drug Program Information Network will be examined to provide information on hospitalizations for cardiac diseases, cardiac procedures performed, cardiac-related and other medications used, and diagnoses with cardiac diseases. Vital statistics will also provide information on cause of death to allow for mortality rate tracking. This administrative health data will be used to compare adverse cardiovascular events with participants recruited under the current protocol to determine if our cardiovascular screening approach predicted which individuals were at moderate to high risk of an adverse cardiovascular outcome over the five-year period after screening. | 5 years post-screening | |
Primary | Hypertension | Each individual's Personal Health Information Number (PHIN) will be utilized to follow the study participants and to determine if they experienced an adverse cardiovascular outcome using the Manitoba Centre for Health Policy (MCHP) Population Health Research Data Repository. Hospital separations abstracts, medical claims and the Drug Program Information Network will be examined to provide information on hospitalizations for cardiac diseases, cardiac procedures performed, cardiac-related and other medications used, and diagnoses with cardiac diseases. Vital statistics will also provide information on cause of death to allow for mortality rate tracking. This administrative health data will be used to compare adverse cardiovascular events with participants recruited under the current protocol to determine if our cardiovascular screening approach predicted which individuals were at moderate to high risk of an adverse cardiovascular outcome over the five-year period after screening. | 5 years post-screening |
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