Cardiovascular Disease Trends 1980-91--A Gender Specific Perspective

February 17, 2016 updated by: National Heart, Lung, and Blood Institute (NHLBI)
To test hypotheses related to gender differences in cardiovascular mortality trends between 1980 and 1991 in two southeastern New England communities which were part of the Pawtucket Heart Health Program.

Study Overview

Status

Completed

Conditions

Detailed Description

BACKGROUND:

The Pawtucket Heart Health Program was a community-based research and demonstration project in cardiovascular disease prevention in the town of Pawtucket, Rhode Island and in the non-intervention comparison town of New Bedford, Massachusetts. The study was initiated by the NHLBI in August, 1980. See also Study 1022.

DESIGN NARRATIVE:

There were four major areas of analysis: 1) gender differences in trends from 1980 to 1991 in total event rates, hospital discharge rates, in-hospital case-fatality and out of hospital deaths for coronary heart disease (CHD) and stroke; 2) gender specific analyses of methodological issues which may affect the interpretation of morbidity and mortality surveillance data; 3) gender differences in the presentation, diagnosis, and treatment of CHD and stroke which may influence morbidity and mortality trends; and 4) gender differences in the association between population trends in risk factors and morbidity and mortality trends.

The study was conducted using morbidity and mortality data collected by the Pawtucket Heart Health Program between 1980 and 1993, and risk factor data obtained through biennial cross-sectional household health surveys conducted in random samples of residents in the two study communities. Morbidity and mortality data were obtained according to standardized epidemiologic surveillance methods. Hospitalized cases of coronary heart disease and stroke were identified through hospital discharge records and were validated using a standardized diagnostic algorithm based on data abstracted from medical records. Out-of-hospital deaths identified through death certificate data were validated using an algorithm based upon medical history data and information concerning the circumstances of death obtained from informant interviews.

Gender specific trends in both age-adjusted and age specific morbidity and mortality were compared. Trends in rates estimated from events classified according to ICD-9 discharge and death certificate codes were contrasted with those estimated from cases validated by standardized diagnostic algorithms. Data regarding circumstances of death and in-hospital treatment were assessed in relation to potential influences on morbidity and mortality trends. Absolute changes over time and average annual percent change over time were evaluated using linear and log-linear regression regression techniques. Other analytic methods included logistic regression and analysis of variance. Expected annual event rates in men and women were estimated from risk factor data using equations based upon accelerated failure time Weibull models, and the impact of risk factors on mortality rates was assessed by comparing predicted with actual rates.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

No eligibility criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1996

Study Completion (Actual)

June 1, 2001

Study Registration Dates

First Submitted

May 25, 2000

First Submitted That Met QC Criteria

May 25, 2000

First Posted (Estimate)

May 26, 2000

Study Record Updates

Last Update Posted (Estimate)

February 18, 2016

Last Update Submitted That Met QC Criteria

February 17, 2016

Last Verified

September 1, 2002

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4956 (Egmont Foundation)
  • R29HL055448 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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