Coronary Artery DiseaseNCT00248859
Determinants of Cardiac Risk Factor Modification in Latinos With Coronary Artery Disease
An observational study of Coronary Artery Disease, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This is an observational study among Latino patients who have coronary artery disease. The goal of the study is to determine the association between having depressive symptoms and the ability to modify one's health behavior. Specifically, participate in physical activity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 198 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Jun 2010
- 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
Study population: Cardiovascular DiSease
Who may be able to join
- Patients must identify their ethnicity as Latino or Hispanic
- Patients must be able to complete a questionnaire in either English or Spanish.
- Patients must have angiographic evidence of coronary artery disease requiring angioplasty
- Patients must also be clinically stable for an interview
- Patient must be able to provide informed consent.
Who cannot join
- Patients who are not clinically stable such as those who had cardiac arrest, who are intubated, who have active psychosis, or who are cognitively impaired.
- Patients who are unable to provide consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Joan and Sanford I. Weill Medical College
New York, New York, 10021
About this study
Official title: Determinants of Cardiac Risk Factors Modification
This is an observational study among Latino patients who have coronary artery disease. The goal of the study is to determine the association between having depressive symptoms and the ability to modify one's health behavior. Specifically, participate in physical activity.
Read the detailed description
Specific aims: Among 213 Latino adult patients who have had coronary artery angioplasty within the past month, the specific aims of the proposed study are:
- To determine whether patients who have more depressive symptoms at the time of angioplasty are less likely to be active in physical activity at two years. Physical activity will be measured by a survey that asks patients to describe their activities including leisure activities or housework.
- To determine whether lower perceived social support, lower self-efficacy for engaging in physical activity, and greater perceived stress mediate the effects of depressive symptoms on participation in physical activity.
Long-term objectives: The long-term objective of this study is to use these data to develop a culturally tailored intervention to increase participation in physical activity and ultimately improve the overall health and well being of Latino adults with coronary artery disease.
Outcome: The outcome is being in the action or maintenance stage of physical activity two years after angioplasty The stage of physical activity participation will be based on the Stages of Change model. This model describes behavior change as a continuum from pre-contemplation to contemplation.
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, Depressive symptoms, Latino American
- Medical subject headings
- Coronary Artery Disease, Depression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2005 (estimated)
- Study startAug 2004
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Carla Boutin-Foster, MD, Weill Medical College of Cornell University
- Investigators
- Carla Boutin-Foster, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00248859
- Sponsor's protocol ID
- HL076567-01
- Other IDs
- 5K01HL076567
- Status last verified
- Feb 2017
- First submitted
- 3 Nov 2005
- Last updated
- 20 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Cardiac Risk Factors Modification
- ClinicalTrials.gov ID
- NCT00248859
- Acronym / sponsor ID
- HL076567-01
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, Depressive symptoms, Latino American
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2004
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 4 Nov 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.
This is an observational study among Latino patients who have coronary artery disease. The goal of the study is to determine the association between having depressive symptoms and the ability to modify one's health behavior. Specifically, participate in physical activity.
Detailed description
Specific aims: Among 213 Latino adult patients who have had coronary artery angioplasty within the past month, the specific aims of the proposed study are:
- To determine whether patients who have more depressive symptoms at the time of angioplasty are less likely to be active in physical activity at two years. Physical activity will be measured by a survey that asks patients to describe their activities including leisure activities or housework.
- To determine whether lower perceived social support, lower self-efficacy for engaging in physical activity, and greater perceived stress mediate the effects of depressive symptoms on participation in physical activity.
Long-term objectives: The long-term objective of this study is to use these data to develop a culturally tailored intervention to increase participation in physical activity and ultimately improve the overall health and well being of Latino adults with coronary artery disease.
Outcome: The outcome is being in the action or maintenance stage of physical activity two years after angioplasty The stage of physical activity participation will be based on the Stages of Change model. This model describes behavior change as a continuum from pre-contemplation to contemplation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiovascular DiSease
Key inclusion criteria (5 listed)
- Patients must identify their ethnicity as Latino or Hispanic
- Patients must be able to complete a questionnaire in either English or Spanish.
- Patients must have angiographic evidence of coronary artery disease requiring angioplasty
- Patients must also be clinically stable for an interview
- Patient must be able to provide informed consent.
Key exclusion criteria (2 listed)
- Patients who are not clinically stable such as those who had cardiac arrest, who are intubated, who have active psychosis, or who are cognitively impaired.
- Patients who are unable to provide consent.
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 20 Feb 2017.
- Individual participant dataSharing planned: No. No plan to share IPD
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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.
Carla Boutin-Foster, MD principal investigator
Weill Medical College of Cornell 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 Coronary Artery Disease, run by Weill Medical College of Cornell University 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 5 inclusion and 2 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 20 Feb 2017. 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 20 Feb 2017.