The Assessment of Large and Small Artery Elasticity for the Early Detection of Cardiovascular Disease

NCT02863211 | Unknown

• 1 other identifier: H2014:224
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Diseases; Vascular Stiffness

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

Assessment of Large and Small Artery Elasticity for the Early Detection of Cardiovascular Disease

One-thousand women 55 years of age or older will be recruited to be screened through the Assessment of Large and Small Artery Elasticity for the Early Detection of Cardiovascular Disease protocol. This involves the cardiovascular assessment of resting blood pressure, blood pressure response to 3-min of moderate intensity exercise and large and small arterial elasticity. The participants will be classified into risk categories based on these measures. The incidence of the following adverse cardiovascular outcomes will be assessed in the five-year period after screening in both groups: Ischemic heart disease, acute myocardial infarction, stroke, percutaneous coronary intervention, coronary bypass surgery, congestive heart failure, and hypertension.

Eligibility Criteria

• Age: 55 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

One-thousand female participants 55 years of age or older will be recruited through a convenience sample method. Namely, we have utilized radio interviews on popular local stations to discuss the study as well as presentations at community events related to cardiovascular health. Poster advertisements have also been placed in key locations related to the Winnipeg Regional Health Authority. Potential study participants interested in participating will contact the research coordinator in person or via telephone.

You may qualify if:

• women aged 55 and older
• possess a Manitoba Personal Health Information Number

You may not qualify if:

• previous hospitalization for:
• ischemic heart disease
• acute myocardial infarction
• stroke
• percutaneous coronary intervention
• coronary artery bypass surgery
• congestive heart failure
• peripheral artery disease

Sponsors & Collaborators

• St. Boniface Hospital: lead

Study Sites (1)

St-Boniface Hospital Albrechtsen Research Center

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Related Publications (26)

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  PMID: 29101147 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Participants are asked to fast for the 12 hours prior to the blood draw at their appointment. Approximately 10 mL of blood is collected by a phlebotomist. The samples are then centrifuged so that the plasma can be separated and analyzed for total cholesterol, high-density lipoprotein, low-density lipoprotein, triglycerides, and fasting glucose.

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Todd A Duhamel, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: August 11, 2016
• Study Start: September 1, 2015
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: December 7, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)