Cardiovascular Health Study (CHS) Events Follow-up Study

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT00149435
First received: September 6, 2005
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

To support follow-up for the Cardiovascular Health Study (CHS) of coronary heart disease and stroke risk factors in adults 65 years or older.


Condition
Cardiovascular Diseases
Coronary Disease
Cerebrovascular Accident
Diabetes Mellitus
Heart Diseases
Hypertension
Heart Failure, Congestive

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Cardiac health [ Time Frame: Annual ] [ Designated as safety issue: No ]
    Incidence of cardiac related death


Enrollment: 5888
Study Start Date: September 2005
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Detailed Description:

BACKGROUND:

The Cardiovascular Health Study (CHS) is an NHLBI-funded cohort study of risk factors for coronary heart disease (CHD) and stroke in adults 65 years or older. In the early 1990s, 5888 participants underwent examinations that included traditional risk factors and measures of sub-clinical disease. During follow-up, many exam components were repeated, and CVD events were ascertained. The National Heart, Lung, and Blood Institute has extended CHS contract funding (1) to implement a model for a transition from contract-funding to investigator-initiated research and (2) to enhance access to CHS data for future papers and ancillary studies by CHS and non-CHS colleagues. The Events Follow-up Study will provide a foundation for the transition. Current and future papers and ancillary studies using CHS data or stored specimens will have additional power and can be conducted more efficiently if a service events-core continues to collect and adjudicate CVD events and deaths in a standardized fashion.

DESIGN NARRATIVE:

Structurally, the primary aims are: (1) to evaluate the incidence rates of and risk factors for CVD in older adults, including comparisons between blacks and whites, men and women, young old and old; (2) the evaluation of prognosis in inception cohorts of older adults with new-onset conditions such as heart failure (HF) and atrial fibrillation; and (3) the evaluation of associations between risk-factor change and the incidence of subsequent events. Questions of interest include: What are the determinants of the low CHD incidence in women 80 yrs and older? Do older black women also have a low CHD incidence? What are the determinants of CHD, HF, and stroke in adults 80 and older? Are risk factors different between men and women, whites and blacks? Do traditional risk factors and measures of sub-clinical disease continue to be powerful predictors of CHD, HF and stroke in those 80 and older? In this study, the investigators expect to make over 20,000 phone calls to identify 6000 hospitalizations, 1000 deaths, 3000 events for detailed review, and 1500 new events, including 370 CHD, 300 stroke, and 450 HF. These new events represent an increase in the number of CVD events of 29% to 35% in whites and an increase of 40% to 49% in blacks. The data and specimens collected in CHS represent a major national resource for the study of health, aging, and cardiovascular disease in older adults. Additional events follow-up will not only provide the opportunity to address the aims of this study, but also enhance the power of current and future CHS papers and ancillary studies by CHS and non-CHS colleagues.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

General population

Criteria

No eligibility criteria

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00149435

Sponsors and Collaborators
University of Washington
Investigators
Study Director: Bruce Psaty University of Washington
  More Information

No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT00149435     History of Changes
Other Study ID Numbers: 1295, 5R01HL080295-07
Study First Received: September 6, 2005
Last Updated: December 18, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Cerebral Infarction
Coronary Artery Disease
Coronary Disease
Diabetes Mellitus
Heart Diseases
Heart Failure
Hypertension
Stroke
Arterial Occlusive Diseases
Arteriosclerosis
Brain Diseases
Brain Infarction
Brain Ischemia
Central Nervous System Diseases
Cerebrovascular Disorders
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Myocardial Ischemia
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 30, 2014