Cardiovascular DiseaseNCT00320905
Smart Heart Study: Cognitive Benefits of Cardiac Rehabilitation
An observational study of Cardiovascular Disease, run by Summa Health System at 1 site in United States.
Trial summary
The proposed study will be the first to examine whether changes in blood flow patterns within the brain account for the possible cognitive benefits of CR. A clearer understanding of this possibility may provide key insight into the way CVD affects the brain, help identify effective treatments, help a greater number of… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Observational
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Mar 2008
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Those with cardiovascular disease
Who may be able to join
- 50 to 85 years of age, able to communicate in English, history of heart disease
Who cannot join
- history of significant neurological disorders, such as stroke, Alzheimer's disease, or severe head injury significant psychological problems such as schizophrenia or bipolar disorder
Trial locations and contacts
1 site in 1 country.
About this study
The proposed study will be the first to examine whether changes in blood flow patterns within the brain account for the possible cognitive benefits of CR. A clearer understanding of this possibility may provide key insight into the way CVD affects the brain, help identify effective treatments, help a greater number of patients return to work, and improve quality of life.
Read the detailed description
Based on recent patient referrals, we expect that 30 participants will subsequently enroll in CR and 30 will not. CR patients will complete standardized neuropsychological tests (45-60 minutes) and Transcranial Doppler (30-40 minutes) during their first and last week in the CR program. Patients who do not enroll in CR will undergo testing at similar intervals to serve as a matched control group. Standard medical records will be collected for participants in both groups to obtain demographic and medical information. CR-specific medical records will also be collected to obtain information about possible mechanisms for cognitive benefits (e.g. improved stress test performance, reduced blood pressure, etc.). All participants will be compensated for their time.
- Conditions
- Cardiovascular Disease
- Being tested
- Observational
- Keywords
- Cardiac Rehabilitation, Cognitive functioning, Cardiovascular disease
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalBehavioural
No intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2006 (estimated)
- Study startMar 2006
- Primary completionFeb 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Summa Health System
- Sponsor type
- University, hospital or other
- Investigators
- Richard A Josephson, MD, Study director, Summa Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00320905
- Sponsor's protocol ID
- RP#05094
- Status last verified
- Jul 2010
- First submitted
- 1 May 2006
- Last updated
- 20 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Heart Study: Cognitive Benefits of Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT00320905
- Acronym / sponsor ID
- RP#05094
- Conditions
- Cardiovascular Disease
- Keywords
- Cardiac Rehabilitation, Cognitive functioning, Cardiovascular disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Summa Health SystemUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 3 May 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.
The proposed study will be the first to examine whether changes in blood flow patterns within the brain account for the possible cognitive benefits of CR. A clearer understanding of this possibility may provide key insight into the way CVD affects the brain, help identify effective treatments, help a greater number of patients return to work, and improve quality of life.
Detailed description
Based on recent patient referrals, we expect that 30 participants will subsequently enroll in CR and 30 will not. CR patients will complete standardized neuropsychological tests (45-60 minutes) and Transcranial Doppler (30-40 minutes) during their first and last week in the CR program. Patients who do not enroll in CR will undergo testing at similar intervals to serve as a matched control group. Standard medical records will be collected for participants in both groups to obtain demographic and medical information. CR-specific medical records will also be collected to obtain information about possible mechanisms for cognitive benefits (e.g. improved stress test performance, reduced blood pressure, etc.). All participants will be compensated for their time.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Those with cardiovascular disease
Key inclusion criteria (1 listed)
- 50 to 85 years of age, able to communicate in English, history of heart disease
Key exclusion criteria (1 listed)
- history of significant neurological disorders, such as stroke, Alzheimer's disease, or severe head injury significant psychological problems such as schizophrenia or bipolar disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalNo intervention | Behavioural | – |
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 Jul 2010.
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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.
Richard A Josephson, MD study director
Summa Health System
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 Disease, run by Summa Health System 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 20 Jul 2010. 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 Jul 2010.