Cardiovascular DiseasesNCT00377702
Lifetime Risk for Cardiovascular Disease Among Non-White Ethnic Groups
An observational study of Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
Cardiovascular disease (CVD) is one of the leading causes of death in the United States. Currently, there is little information about the lifetime risk of CVD among non-white ethnic groups. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Heart Failure, Congestive
- How many people
- 500,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Jul 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participating in a specified epidemiologic study
Who cannot join
- Pre-existing CVD prior to study entry
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Department of Preventive Medicine
Chicago, Illinois, 60611
About this study
Official title: Epidemiologic Study of Ethnicity and Lifetime Risks for Cardiovascular Disease
Cardiovascular disease (CVD) is one of the leading causes of death in the United States. Currently, there is little information about the lifetime risk of CVD among non-white ethnic groups. This study will analyze data from participants in several ongoing clinical studies to identify the lifetime risk for CVD among various ethnicities.
Read the detailed description
CVD affects millions of people in the United States. Current treatment guidelines for CVD take into account an individual's risk of developing the disease within 10 years; the intensity of therapy is usually matched to the 10-year risk magnitude. However, many individuals have a low 10-year risk of CVD, but have an elevated lifetime risk of developing the disease. Unfortunately, few studies have examined the lifetime risks for CVD, and these studies have been almost exclusively performed in the Caucasian population. There have been no studies that focus on the lifetime risks for CVD among other ethnic groups. Because the incidence of CVD and other causes of death vary among different ethnic groups, it is important to examine each group separately. Using data from ongoing clinical studies, this study will evaluate the lifetime risks for CVD among different ethnic groups. The results from this study will assist in estimating the future incidence of CVD among ethnic groups, improving risk communication within patient care, and identifying new populations of individuals at risk for CVD.
This study will use previously collected data on 500,000 individuals participating in pre-specified clinical studies. Some of the participating studies include the following: Atherosclerosis Risk in Communities, Framingham Heart, Honolulu Heart, Puerto Rico Heart Health, Coronary Artery Risk Development in Young Adults (CARDIA), Cardiovascular Health, Chicago Heart Association Detection Project in Industry, Women's Health Initiative Observational Studies, and Multiple Risk Factor Intervention Trial (MRFIT). There will be no study visits specifically for this study. Researchers will collect information on CVD risk factors and demographics, including sex, race, and age; they will then compare this information to overall survival, CVD associated survival, and lifetime risk for CVD.
- Keywords
- Coronary Heart Disease, Risk Factors, Heart Failure
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Heart Failure, Atrial Fibrillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2006 (estimated)
- Study startJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 500,000 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Donald M. Lloyd-Jones, MD, ScM, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00377702
- Sponsor's protocol ID
- 1350
- Other IDs
- R21HL085375
- Status last verified
- Dec 2007
- First submitted
- 14 Sep 2006
- Last updated
- 18 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiologic Study of Ethnicity and Lifetime Risks for Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT00377702
- Acronym / sponsor ID
- 1350
- Keywords
- Coronary Heart Disease, Risk Factors, Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500,000 participants
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jul 2006
- Study completion
- Jul 2006 (actual)
- First posted
- 18 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cardiovascular disease (CVD) is one of the leading causes of death in the United States. Currently, there is little information about the lifetime risk of CVD among non-white ethnic groups. This study will analyze data from participants in several ongoing clinical studies to identify the lifetime risk for CVD among various ethnicities.
Detailed description
CVD affects millions of people in the United States. Current treatment guidelines for CVD take into account an individual's risk of developing the disease within 10 years; the intensity of therapy is usually matched to the 10-year risk magnitude. However, many individuals have a low 10-year risk of CVD, but have an elevated lifetime risk of developing the disease. Unfortunately, few studies have examined the lifetime risks for CVD, and these studies have been almost exclusively performed in the Caucasian population. There have been no studies that focus on the lifetime risks for CVD among other ethnic groups. Because the incidence of CVD and other causes of death vary among different ethnic groups, it is important to examine each group separately. Using data from ongoing clinical studies, this study will evaluate the lifetime risks for CVD among different ethnic groups. The results from this study will assist in estimating the future incidence of CVD among ethnic groups, improving risk communication within patient care, and identifying new populations of individuals at risk for CVD.
This study will use previously collected data on 500,000 individuals participating in pre-specified clinical studies. Some of the participating studies include the following: Atherosclerosis Risk in Communities, Framingham Heart, Honolulu Heart, Puerto Rico Heart Health, Coronary Artery Risk Development in Young Adults (CARDIA), Cardiovascular Health, Chicago Heart Association Detection Project in Industry, Women's Health Initiative Observational Studies, and Multiple Risk Factor Intervention Trial (MRFIT). There will be no study visits specifically for this study. Researchers will collect information on CVD risk factors and demographics, including sex, race, and age; they will then compare this information to overall survival, CVD associated survival, and lifetime risk for CVD.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participating in a specified epidemiologic study
Key exclusion criteria (1 listed)
- Pre-existing CVD prior to study entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald M. Lloyd-Jones, MD, ScM principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2016.