ICA-CHAMP: Indo-Central Asian Cardiovascular Health Assessment and Management Program - Full Text View

Sponsors and Collaborators:	University of Calgary Pfizer
Information provided by:	University of Calgary
ClinicalTrials.gov Identifier:	NCT00627159

Purpose

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:

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

Condition	Intervention
Cardiovascular Diseases Hypertension Hyperlipidemia	Other: High risk assessment Other: Low to moderate risk

MedlinePlus related topics: Cholesterol Heart Diseases High Blood Pressure

Drug Information available for: Cholest-5-en-3-ol (3beta)-

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Screening, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	ICA-CHAMP: Indo-Central Asian Cardiovascular Health Assessment and Management Program

Further study details as provided by University of Calgary:

Primary Outcome Measures:

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) [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: one year ] [ Designated as safety issue: No ]
Baseline profiles of attendees versus no-shows at both High Risk Assessment clinics and Calgary Health Region Multicultural education programs [ Time Frame: one year ] [ Designated as safety issue: No ]
"No-show" rates at High Risk Assessment clinics and Calgary Health Region Multicultural education program vs. historical rates. [ Time Frame: one year ] [ Designated as safety issue: No ]
Proportion of High Risk Assessment Clinic attendees identified as having occult Coronary Artery Disease and requiring angioplasty and/or Coronary Artery Bypass Graft. [ Time Frame: one year ] [ Designated as safety issue: No ]
Post Hoc variation of the Joint British Societies Cardiovascular Disease Risk Prediction Chart versus ETHRISK [ Time Frame: one year ] [ Designated as safety issue: No ]
Participant and community leader/volunteer satisfaction with the program [ Time Frame: one year ] [ Designated as safety issue: No ]
Participant opinion regarding usefulness of the culturally-sensitive educational information provided at the screening session. [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment:	375
Study Start Date:	May 2007
Estimated Study Completion Date:	June 2008
Estimated Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 high risk	Other: High risk assessment 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.
2 low to moderate risk	Other: Low to moderate risk 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.

Arms

Assigned Interventions

1

high risk

Other: High risk assessment

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.

2

low to moderate risk

Other: Low to moderate risk

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.

Show Detailed Description

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Pregnancy
Current cardiology specialist

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00627159

Locations

Canada, Alberta
Hindu Society of Calgary
Calgary, Alberta, Canada, T2E 8M2
Dashmesh Cultural Centre
Calgary, Alberta, Canada, T3J 3G5

Sponsors and Collaborators

University of Calgary

Pfizer

Investigators

Principal Investigator:

Charlotte - Jones, PhD, MD

University of Calgary

More Information

Related Info This link exits the ClinicalTrials.gov site

Publications:

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. Review.

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.

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.

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.

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. Epub 2006 Jun 8.

British Cardiac Society, British Hypertension Society, Diabetes UK, HEART UK, Primary Care Cardiovascular Society, The Stroke Association. JBS 2: Joint Britich Societies' guidelines on prevention of cardiovascular disease in clinical practice. Heart 91(5): 2005

Responsible Party:	University of Calgary ( Dr. Charlotte Jones )
Study ID Numbers:	NRA3840015
Study First Received:	January 14, 2008
Last Updated:	February 20, 2008
ClinicalTrials.gov Identifier:	NCT00627159
Health Authority:	Canada: Health Canada

Keywords provided by University of Calgary:

community-based
culturally-sensitive
high risk assessment

education classes
cardiovascular risk profile
Indo-Asian population

Study placed in the following topic categories:

Metabolic Diseases
Hyperlipidemias
Vascular Diseases
Metabolic disorder

Dyslipidemias
Lipid Metabolism Disorders
Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009