a Myocardial InfarctionPhase 4NCT00243581
The Effects of an Intensive Lifestyle Modification Program on Carotid Artery Intima-Media Thickness
A Phase 4 study testing Dean Ornish Heart Disease Reversing Program in people with a Myocardial Infarction and Coronary Artery Bypass Graft Surgery Percutaneous Transluminal Coronary Angioplasty Stent Placement, run by SwedishAmerican Health System.
Trial summary
The objective of this study is to evaluate the effect of the Ornish Program on cardiovascular disease as measured by the IMT of the common carotid artery, and to compare this effect to outcomes from patients participating in traditional cardiac rehabilitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- a Myocardial Infarction, Coronary Artery Bypass Graft Surgery Percutaneous Transluminal Coronary Angioplasty Stent Placement
- What is being tested?
- Dean Ornish Heart Disease Reversing Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Aug 2000to May 2005
- Phase
- Phase 4
- 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
- Adult, Older adult
Who may be able to join
- Patients will be accepted into the study if they demonstrate one or more of the following within the previous 12 months: a myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty, stent placement, or rotoblator procedures. Patients will also accepted if they have stable angina as determined by the Rose Questionnaire or pacemaker associated with one or more of the previously mentioned diagnoses. For the purposes of this study, myocardial infarction is defined as the presence of at least two of the following three criteria: continuous chest pain lasting at least 30 minutes; electrocardiogram changes expressing an evolving myocardial infarction (ST segment elevation or depression, evolving Q waves, or symmetric inversion of T waves); or elevated cardiac enzyme levels (at least twice the I levels).
Who cannot join
- -
About this study
The objective of this study is to evaluate the effect of the Ornish Program on cardiovascular disease as measured by the IMT of the common carotid artery, and to compare this effect to outcomes from patients participating in traditional cardiac rehabilitation.
- Conditions
- a Myocardial Infarction, Coronary Artery Bypass Graft Surgery Percutaneous Transluminal Coronary Angioplasty Stent Placement
- Being tested
- Dean Ornish Heart Disease Reversing Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dean Ornish Heart Disease Reversing ProgramBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2005 (estimated)
- Study startAug 2000
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for a Myocardial InfarctionStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- SwedishAmerican Health System
- Sponsor type
- University, hospital or other
- Investigators
- Steven G. Aldana, Ph.D., Principal investigator, SwedishAmerican Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00243581
- Sponsor's protocol ID
- SACCM Ornish Clinical Trial
- Status last verified
- May 2005
- First submitted
- 21 Oct 2005
- Last updated
- 31 Oct 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of an Intensive Lifestyle Modification Program on Carotid Artery Intima-Media Thickness
- ClinicalTrials.gov ID
- NCT00243581
- Acronym / sponsor ID
- SACCM Ornish Clinical Trial
- Conditions
- a Myocardial Infarction, Coronary Artery Bypass Graft Surgery Percutaneous Transluminal Coronary Angioplasty Stent Placement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- SwedishAmerican Health SystemUniversity, hospital or other
- Study start
- Aug 2000
- Study completion
- May 2005
- First posted
- 24 Oct 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.
The objective of this study is to evaluate the effect of the Ornish Program on cardiovascular disease as measured by the IMT of the common carotid artery, and to compare this effect to outcomes from patients participating in traditional cardiac rehabilitation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients will be accepted into the study if they demonstrate one or more of the following within the previous 12 months: a myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty, stent placement, or rotoblator procedures. Patients will also accepted if they have stable angina as determined by the Rose Questionnaire or pacemaker associated with one or more of the previously mentioned diagnoses. For the purposes of this study, myocardial infarction is defined as the presence of at least two of the following three criteria: continuous chest pain lasting at least 30 minutes; electrocardiogram changes expressing an evolving myocardial infarction (ST segment elevation or depression, evolving Q waves, or symmetric inversion of T waves); or elevated cardiac enzyme levels (at least twice the I levels).
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Dean Ornish Heart Disease Reversing Program | 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 31 Oct 2005.
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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.
Steven G. Aldana, Ph.D. principal investigator
SwedishAmerican Health System
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dean Ornish Heart Disease Reversing Program in people with a Myocardial Infarction and Coronary Artery Bypass Graft Surgery Percutaneous Transluminal Coronary Angioplasty Stent Placement, run by SwedishAmerican Health System.
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 31 Oct 2005. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 31 Oct 2005.