Cardiovascular DiseasesNCT00106951
Effects of Neighborhood SES on Coronary Heart Disease Burden in Communities - Ancillary to ARIC
An observational study of Cardiovascular Diseases and Coronary Disease, run by University of North Carolina, Chapel Hill.
Trial summary
To investigate the role of racial and socioeconomic disparities in coronary heart disease (CHD) mortality in the United States. Read more about this study
- Who is it for?
- Ages 35 to 74 years
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
- How many people
- 12,000 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to Mar 2009
- 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 35 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community surveillance of adults in four communities in the US
hospitalized and fatal coronary heart disease cases eligibility: within 4 defined geographic areas and ages 35 to 74 years of age
About this study
To investigate the role of racial and socioeconomic disparities in coronary heart disease (CHD) mortality in the United States.
Read the detailed description
BACKGROUND:
Despite strong decreases in coronary heart disease (CHD) mortality over past decades, there is evidence that racial and socioeconomic disparities in CHD mortality are increasing. CHD surveillance efforts that examine trends within these population subgroups are an important first step in quantifying and reducing disparities. The Atherosclerosis Risk in Communities (ARIC) Study has monitored rates and trends in validated hospitalized myocardial infarction and fatal CHD among black and white adults aged 35 to 74 years in four U.S. communities since 1989.
DESIGN NARRATIVE:
The study will expand the scope of ARIC surveillance by examining variations in the rates and temporal trends in CHD by socioeconomic status (SES), measured at the level of census tract. For CHD events already included in ARIC surveillance (1992-2002), addresses will be obtained from medical records and death certificates and geocoded so that they can be matched with identifiers for census based geographical areas. The ARIC study will contribute yearly updates of abstracted CHD events and addresses for subsequent years (2003-2005). Each event will be linked with census tract level SES indicators available from the 1990 and 2000 censuses. This novel effort will permit an examination of disparities by SES in rates and trends in fatal CHD, hospitalized myocardial infarction, case fatality, use of invasive cardiac procedures and prescription of efficacious medication at time of hospital discharge. In addition, the extent to which racial disparities in CHD and associated treatments are explained by SES will also be explored.
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
- Keywords
- Surveillance, coronary heart disease, neighborhood SES
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2005 (estimated)
- Study startApr 2005
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- 12,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Kathryn Rose, University of North Carolina, Chapel Hill
- Investigators
- Kathryn M Rose, PhD, Principal investigator, UNC (Adjunct)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00106951
- Sponsor's protocol ID
- 1292
- Other IDs
- R01HL080287
- Status last verified
- Jan 2012
- First submitted
- 1 Apr 2005
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Foraker RE, Rose KM, Kucharska-Newton AM, Ni H, Suchindran CM, Whitsel EA. Variation in rates of fatal coronary heart disease by neighborhood socioeconomic status: the atherosclerosis risk in communities surveillance (1992-2002). Ann Epidemiol. 2011 Aug;21(8):580-8. doi: 10.1016/j.annepidem.2011.03.004. Epub 2011 Apr 23.
PubMed 21524592Foraker RE, Rose KM, Whitsel EA, Suchindran CM, Wood JL, Rosamond WD. Neighborhood socioeconomic status, Medicaid coverage and medical management of myocardial infarction: atherosclerosis risk in communities (ARIC) community surveillance. BMC Public Health. 2010 Oct 21;10:632. doi: 10.1186/1471-2458-10-632.
PubMed 20964853Rose KM, Suchindran CM, Foraker RE, Whitsel EA, Rosamond WD, Heiss G, Wood JL. Neighborhood disparities in incident hospitalized myocardial infarction in four U.S. communities: the ARIC surveillance study. Ann Epidemiol. 2009 Dec;19(12):867-74. doi: 10.1016/j.annepidem.2009.07.092. Epub 2009 Oct 7.
PubMed 19815428Foraker RE, Rose KM, McGinn AP, Suchindran CM, Goff DC Jr, Whitsel EA, Wood JL, Rosamond WD. Neighborhood income, health insurance, and prehospital delay for myocardial infarction: the atherosclerosis risk in communities study. Arch Intern Med. 2008 Sep 22;168(17):1874-9. doi: 10.1001/archinte.168.17.1874.
PubMed 18809814
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neighborhood SES on Coronary Heart Disease Burden in Communities - Ancillary to ARIC
- ClinicalTrials.gov ID
- NCT00106951
- Acronym / sponsor ID
- 1292
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
- Keywords
- Surveillance, coronary heart disease, neighborhood SES
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,000 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 2005
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 4 Apr 2005 (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.
To investigate the role of racial and socioeconomic disparities in coronary heart disease (CHD) mortality in the United States.
Detailed description
BACKGROUND:
Despite strong decreases in coronary heart disease (CHD) mortality over past decades, there is evidence that racial and socioeconomic disparities in CHD mortality are increasing. CHD surveillance efforts that examine trends within these population subgroups are an important first step in quantifying and reducing disparities. The Atherosclerosis Risk in Communities (ARIC) Study has monitored rates and trends in validated hospitalized myocardial infarction and fatal CHD among black and white adults aged 35 to 74 years in four U.S. communities since 1989.
DESIGN NARRATIVE:
The study will expand the scope of ARIC surveillance by examining variations in the rates and temporal trends in CHD by socioeconomic status (SES), measured at the level of census tract. For CHD events already included in ARIC surveillance (1992-2002), addresses will be obtained from medical records and death certificates and geocoded so that they can be matched with identifiers for census based geographical areas. The ARIC study will contribute yearly updates of abstracted CHD events and addresses for subsequent years (2003-2005). Each event will be linked with census tract level SES indicators available from the 1990 and 2000 censuses. This novel effort will permit an examination of disparities by SES in rates and trends in fatal CHD, hospitalized myocardial infarction, case fatality, use of invasive cardiac procedures and prescription of efficacious medication at time of hospital discharge. In addition, the extent to which racial disparities in CHD and associated treatments are explained by SES will also be explored.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 35 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community surveillance of adults in four communities in the US
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 31 Jan 2012.
- Results publication: PubMed 21524592Foraker RE, Rose KM, Kucharska-Newton AM, Ni H, Suchindran CM, Whitsel EA. Variation in rates of fatal coronary heart disease by neighborhood socioeconomic status: the atherosclerosis risk in communities surveillance (1992-2002). Ann Epidemiol. 2011 Aug;21(8):580-8. doi: 10.1016/j.annepidem.2011.03.004. Epub 2011 Apr 23.
- Results publication: PubMed 20964853Foraker RE, Rose KM, Whitsel EA, Suchindran CM, Wood JL, Rosamond WD. Neighborhood socioeconomic status, Medicaid coverage and medical management of myocardial infarction: atherosclerosis risk in communities (ARIC) community surveillance. BMC Public Health. 2010 Oct 21;10:632. doi: 10.1186/1471-2458-10-632.
- Results publication: PubMed 19815428Rose KM, Suchindran CM, Foraker RE, Whitsel EA, Rosamond WD, Heiss G, Wood JL. Neighborhood disparities in incident hospitalized myocardial infarction in four U.S. communities: the ARIC surveillance study. Ann Epidemiol. 2009 Dec;19(12):867-74. doi: 10.1016/j.annepidem.2009.07.092. Epub 2009 Oct 7.
- Results publication: PubMed 18809814Foraker RE, Rose KM, McGinn AP, Suchindran CM, Goff DC Jr, Whitsel EA, Wood JL, Rosamond WD. Neighborhood income, health insurance, and prehospital delay for myocardial infarction: the atherosclerosis risk in communities study. Arch Intern Med. 2008 Sep 22;168(17):1874-9. doi: 10.1001/archinte.168.17.1874.
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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.
Kathryn M Rose, PhD principal investigator
UNC (Adjunct)
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Coronary Disease, run by University of North Carolina, Chapel Hill.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 31 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
On the ClinicalTrials.gov record for NCT00106951, which also lists 4 linked publications.
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 31 Jan 2012.