NCT00627159

Brief Summary

Research has shown that the presence of heart disease and stroke is higher in the Indo-Asian population compared to other ethno-cultural groups. This may be due to multiple reasons such as a higher presence of diabetes, high blood pressure, high cholesterol, obesity, and lower levels of physical activity. This program will bring together the Calgary Indo-Central-Asian communities and the Calgary Healthcare community to help reduce the rate of heart disease and stroke through a supportive, culturally-sensitive program that is community-based through the following steps:

  1. 1.Increase awareness of heart disease and stroke through education among the Calgary Indo-Central-Asian population.
  2. 2.Identify early, the risk factors related to heart disease and stroke through screening programs.
  3. 3.Provide appropriate follow-up care to the population at risk for heart disease and stroke.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
375

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
Completed

Started May 2007

Shorter than P25 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2008

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 29, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

February 29, 2008

Status Verified

February 1, 2008

Enrollment Period

11 months

First QC Date

January 14, 2008

Last Update Submit

February 20, 2008

Conditions

Cardiovascular DiseasesHypertensionHyperlipidemia

Keywords

community-basedculturally-sensitivehigh risk assessmenteducation classescardiovascular risk profileIndo-Asian population

Outcome Measures

Primary Outcomes (1)

  • Baseline and one year change in blood pressure and total cholesterol, HDL cholesterol and TC/HDL ratio (High and low to moderate risk program participants)

    one year

Secondary Outcomes (7)

  • Cardiovascular risk profile and risk scores (Joint British Societies Cardiovascular Disease Risk Prediction Chart) of all participants at baseline and upon completion of the High Risk Assessment and Calgary Health Region Multicultural education programs.

    one year

  • Baseline profiles of attendees versus no-shows at both High Risk Assessment clinics and Calgary Health Region Multicultural education programs

    one year

  • "No-show" rates at High Risk Assessment clinics and Calgary Health Region Multicultural education program vs. historical rates.

    one year

  • Proportion of High Risk Assessment Clinic attendees identified as having occult Coronary Artery Disease and requiring angioplasty and/or Coronary Artery Bypass Graft.

    one year

  • Post Hoc variation of the Joint British Societies Cardiovascular Disease Risk Prediction Chart versus ETHRISK

    one year

  • +2 more secondary outcomes

Study Arms (2)

1

OTHER

high risk

Other: High risk assessment

2

OTHER

low to moderate risk

Other: Low to moderate risk

Interventions

High risk assessmentOTHER

For all participants screened in the program, a cardiovascular risk profile is determined using information from the cardiovascular health history, blood pressure and cholesterol measurements, and The British Joint Societies Risk Prediction chart. All participants predicted to be at high risk are referred for assessment to a High Risk clinic in the community via the family doctor.

1
Low to moderate riskOTHER

For all participants screened in the program, a cardiovascular risk profile is determined using information from the cardiovascular health history, blood pressure and cholesterol measurements, and The British Joint Societies Risk Prediction chart. All low to -moderate risk participants are directed to self-refer to the Calgary Health Region Multicultural education classes.

2

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Indo-Cental Asian decent
  • Minimum 45 years of age
  • Signed informed consent

You may not qualify if:

  • Pregnancy
  • Current cardiology specialist

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hindu Society of Calgary

Calgary, Alberta, T2E 8M2, Canada

Location

Dashmesh Cultural Centre

Calgary, Alberta, T3J 3G5, Canada

Location

Related Publications (6)

  • Bedi US, Singh S, Syed A, Aryafar H, Arora R. Coronary artery disease in South Asians: an emerging risk group. Cardiol Rev. 2006 Mar-Apr;14(2):74-80. doi: 10.1097/01.crd.0000182411.88146.72.

    PMID: 16493244BACKGROUND

  • Aarabi M, Jackson PR. Predicting coronary risk in UK South Asians: an adjustment method for Framingham-based tools. Eur J Cardiovasc Prev Rehabil. 2005 Feb;12(1):46-51.

    PMID: 15703505BACKGROUND

  • Anand SS, Yusuf S, Vuksan V, Devanesen S, Teo KK, Montague PA, Kelemen L, Yi C, Lonn E, Gerstein H, Hegele RA, McQueen M. Differences in risk factors, atherosclerosis, and cardiovascular disease between ethnic groups in Canada: the Study of Health Assessment and Risk in Ethnic groups (SHARE). Lancet. 2000 Jul 22;356(9226):279-84. doi: 10.1016/s0140-6736(00)02502-2.

    PMID: 11071182BACKGROUND

  • Davachi S, Flynn M, Edwards A. A health region/community partnership for Type 2 diabetes risk factor screening in Indo-Asian communities. Canadian Journal of Diabetes 29(2):87-94, 2005.

    BACKGROUND

  • Brindle P, May M, Gill P, Cappuccio F, D'Agostino R Sr, Fischbacher C, Ebrahim S. Primary prevention of cardiovascular disease: a web-based risk score for seven British black and minority ethnic groups. Heart. 2006 Nov;92(11):1595-602. doi: 10.1136/hrt.2006.092346. Epub 2006 Jun 8.

    PMID: 16762981BACKGROUND

  • British Cardiac Society; British Hypertension Society; Diabetes UK; HEART UK; Primary Care Cardiovascular Society; Stroke Association. JBS 2: Joint British Societies' guidelines on prevention of cardiovascular disease in clinical practice. Heart. 2005 Dec;91 Suppl 5(Suppl 5):v1-52. doi: 10.1136/hrt.2005.079988. No abstract available.

    PMID: 16365341BACKGROUND

Related Links

MeSH Terms

Conditions

Cardiovascular DiseasesHypertensionHyperlipidemias

Condition Hierarchy (Ancestors)

Vascular DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Charlotte - Jones, PhD, MD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 14, 2008

First Posted

February 29, 2008

Study Start

May 1, 2007

Primary Completion

April 1, 2008

Study Completion

June 1, 2008

Last Updated

February 29, 2008

Record last verified: 2008-02

Locations

CA(2)