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ICA-CHAMP: Indo-Central Asian Cardiovascular Health Assessment and Management Program (ICA-CHAMP)

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ClinicalTrials.gov Identifier: NCT00627159
Recruitment Status : Unknown
Verified February 2008 by University of Calgary.
Recruitment status was:  Active, not recruiting
First Posted : February 29, 2008
Last Update Posted : February 29, 2008
Sponsor:
Collaborator:
Pfizer
Information provided by:
University of Calgary

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

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Hypertension Hyperlipidemia Other: High risk assessment Other: Low to moderate risk Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 375 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: ICA-CHAMP: Indo-Central Asian Cardiovascular Health Assessment and Management Program
Study Start Date : May 2007
Estimated Primary Completion Date : April 2008
Estimated Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  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) [ Time Frame: one year ]

Secondary Outcome Measures :
  1. 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 ]
  2. Baseline profiles of attendees versus no-shows at both High Risk Assessment clinics and Calgary Health Region Multicultural education programs [ Time Frame: one year ]
  3. "No-show" rates at High Risk Assessment clinics and Calgary Health Region Multicultural education program vs. historical rates. [ Time Frame: one year ]
  4. 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 ]
  5. Post Hoc variation of the Joint British Societies Cardiovascular Disease Risk Prediction Chart versus ETHRISK [ Time Frame: one year ]
  6. Participant and community leader/volunteer satisfaction with the program [ Time Frame: one year ]
  7. Participant opinion regarding usefulness of the culturally-sensitive educational information provided at the screening session. [ Time Frame: one year ]


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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications:
Responsible Party: Dr. Charlotte Jones, University of Calgary
ClinicalTrials.gov Identifier: NCT00627159     History of Changes
Other Study ID Numbers: NRA3840015
First Posted: February 29, 2008    Key Record Dates
Last Update Posted: February 29, 2008
Last Verified: February 2008

Keywords provided by University of Calgary:
community-based
culturally-sensitive
high risk assessment
education classes
cardiovascular risk profile
Indo-Asian population

Additional relevant MeSH terms:
Cardiovascular Diseases
Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases