CHA-CHA: Cardiovascular Disease Risk Factors in Chinese American Immigrants

• Sponsor: Albert Einstein College of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT00362128
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 2,072
• Location: 1
• Duration (Months): 33
• Patients Per Site Per Month: 62.8

Study Details

Study Description

Brief Summary

The Chinese population is currently the fastest growing ethnic group in New York City (NYC). Research has shown that Chinese immigrants living in NYC have higher rates of cardiovascular disease (CVD) than individuals in China. This study will evaluate the effect that acculturation has on health habits and CVD risk factors in Chinese immigrants living in NYC.

Condition or Disease	Intervention/Treatment	Phase
Hypertension; Cardiovascular Diseases; Diabetes Mellitus; Metabolic Syndrome X

Detailed Description

CVD includes diseases that affect the heart and blood vessels. The underlying cause of CVD is atherosclerosis, in which fatty plaques develop on the inner walls of arteries. There are many risk factors for CVD, including inflammation, high blood pressure, high cholesterol, and obesity. Research has shown that CVD mortality rates differ greatly between Chinese immigrants living in NYC and individuals living in China. Because of this difference, it is important to understand the impact of immigration and acculturation on health habits and psychosocial factors, which may influence the development of CVD. This study will gather information from Chinese immigrants in NYC to identify the impact of immigration and acculturation on behavior and CVD risk factors. In addition, results from this study may provide insight into the CVD risk patterns in other immigrant groups.

This study will enroll Chinese immigrants living in NYC. Participants will attend one study visit and will complete questionnaires to assess their health habits (diet, physical activity, and smoking), stress levels, and socioeconomic status. Participants will also undergo a physical examination and blood collection.

Study Design

• Study Type: Observational
• Actual Enrollment: 2072 participants
• Observational Model: Ecologic or Community
• Time Perspective: Cross-Sectional
• Official Title: Chinese American Cardiovascular Health Assessment CHA-CHA
• Study Start Date: Jan 1, 2007
• Actual Primary Completion Date: Jul 1, 2009
• Actual Study Completion Date: Oct 1, 2009

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Hypertension [4 years]

   Systolic BP above 129 or Diastolic BP above 79.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Chinese immigrant

• Currently residing in NYC

Exclusion Criteria:

• Under 18 years of age

• Not of Chinese dissent

• Born outside mainland China

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York Downtown Hospital	New York	New York	United States	10038

Sponsors and Collaborators

• Albert Einstein College of Medicine
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Judith Wylie-Rosett, EdD, Albert Einstein College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Judith Wylie-Rosett, Principal Investigator, Albert Einstein College of Medicine
• ClinicalTrials.gov Identifier: NCT00362128
• Other Study ID Numbers: 2005-400; R01HL077809
• First Posted: Aug 9, 2006
• Last Update Posted: Jan 21, 2020
• Last Verified: Jan 1, 2020

• Keywords provided by Judith Wylie-Rosett, Principal Investigator, Albert Einstein College of Medicine: Blood Pressure, High; Obesity; Tobacco Use Disorder
• Additional relevant MeSH terms: Cardiovascular Diseases; Metabolic Syndrome

Study Results

Participant Flow

Arm/Group Title	Observational
Arm/Group Description	The study design was a cross-sectional observational cohort design.
Period Title: Overall Study
STARTED	2072
COMPLETED	2072
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Observational
Arm/Group Description	The study design was a cross-sectional observational cohort design.
Overall Participants	2072
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	1682 81.2%
>=65 years	390 18.8%
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	53
Sex: Female, Male (Count of Participants)
Female	1093 52.8%
Male	979 47.2%
Region of Enrollment (participants) [Number]
United States	2072 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Hypertension
Description	Systolic BP above 129 or Diastolic BP above 79.
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Observational
Arm/Group Description	The study design was a cross-sectional observational cohort design.
Measure Participants	2072
Number [participants]	532 25.7%

Adverse Events

Arm/Group Title	Observational
Arm/Group Description	The study design was a cross-sectional observational cohort design.
All Cause Mortality
	Observational
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Observational
	Affected / at Risk (%)	# Events
Total	0/2072 (0%)
Other (Not Including Serious) Adverse Events
	Observational
	Affected / at Risk (%)	# Events
Total	0/2072 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.