Cardiovascular DiseasesNCT00099411
Heart Muscle Viability and Remodeling in Individuals Post-Heart Attack
An observational study of Cardiovascular Diseases and Coronary Disease, run by Tufts Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to assess the effect of heart muscle viability on left ventricular (LV) remodeling after a heart attack; to explore the relationships between retained viability of the area of tissue death (infarct zone), LV remodeling, response to the Occluded Artery Trial (OAT) intervention, and response… Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Myocardial Infarction
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to 30 Jun 2007
- 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 Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: People who have experienced a heart attack 3 to 28 days prior to study entry.
Who may be able to join
- Has experienced a heart attack 3 to 28 days prior to study entry
- Has an occluded IRA at catheterization
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Myocardial Viability and Remodeling in the Occluded Artery Trial (OAT)-Ancillary to OAT
The purpose of this study is to assess the effect of heart muscle viability on left ventricular (LV) remodeling after a heart attack; to explore the relationships between retained viability of the area of tissue death (infarct zone), LV remodeling, response to the Occluded Artery Trial (OAT) intervention, and response to late percutaneous coronary intervention of the infarct related artery (IRA).
Read the detailed description
BACKGROUND:
Coronary heart disease is a major health problem in the United States. It is estimated that in 2003, more than 600,000 Americans had a new heart attack, and more than 400,000 experienced a recurrent heart attack. Up to 40% of individuals with a new or recurrent heart attack will show a complete occlusion, or blocking, of the IRA on follow-up angiography. Many people with an occluded IRA post-heart attack are at risk for progressive LV remodeling in the heart, which can lead to congestive heart failure.
The NHLBI-funded OAT study is testing the hypothesis that opening an occluded IRA 3 to 28 days following a heart attack will reduce the composite endpoint of mortality, recurrent heart attack, and New York Heart Association class IV heart failure over a three-year follow-up period. OAT has enrolled approximately 1,100 participants at 240 centers in 24 countries. Among the mechanisms proposed to explain the benefit of late revascularization, recovery of LV function and attenuation of LV remodeling due to restoration of blood flow to viable myocardium, or heart muscle, is the most plausible.
DESIGN NARRATIVE:
An estimated 200 individuals who have had a heart attack will be enrolled in this study. The primary aims of this study are the following: 1) to test the hypothesis that participants who demonstrate preservation of viability within the infarct zone will have less progressive remodeling compared to participants exhibiting predominant infarct, and 2) to test the hypothesis that preservation of viability will modify the treatment effect of randomization to late revascularization in participants with an occluded IRA 3 to 28 days after the heart attack. All participants will have resting gated Tc-99m sestamibi SPECT imaging at baseline, and again 1 year later. Parameters of baseline viability within the infarct zone, and serial measures of LV volume change and function will be centrally assessed by the Cardiac Imaging Core Laboratory at Tufts Medical Center. The major study endpoint to address the hypotheses will be serial change in LV end-diastolic volume, based on the degree of preservation of viability within the defined infarct zone. Sample size calculations will be based on data evaluated by the same group from a similar number of participants studied at a similar number of clinical sites.
- Conditions
- Cardiovascular Diseases, Coronary Disease, Myocardial Infarction, Heart Diseases, Heart Failure, Congestive
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Myocardial Infarction, Heart Diseases, Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end point of LV remodeling was assessed by change in LV EDV from baseline to 1 year.
The primary end point of LV remodeling was assessed by change in LV EDV from baseline to 1 year.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2004 (estimated)
- Study startJan 2004
- Primary completion30 Jun 2007
- Study completion30 Jun 2007
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.
- 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
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- James E. Udelson, Study chair, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00099411
- Sponsor's protocol ID
- 1279
- Other IDs
- R01HL075456
- Status last verified
- Apr 2017
- First submitted
- 13 Dec 2004
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Viability and Remodeling in the Occluded Artery Trial (OAT)-Ancillary to OAT
- ClinicalTrials.gov ID
- NCT00099411
- Acronym / sponsor ID
- 1279
- Conditions
- Cardiovascular Diseases, Coronary Disease, Myocardial Infarction, Heart Diseases, Heart Failure, Congestive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2004 (actual)
- Primary completion
- 30 Jun 2007 (actual)
- Study completion
- 30 Jun 2007 (actual)
- First posted
- 14 Dec 2004 (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 purpose of this study is to assess the effect of heart muscle viability on left ventricular (LV) remodeling after a heart attack; to explore the relationships between retained viability of the area of tissue death (infarct zone), LV remodeling, response to the Occluded Artery Trial (OAT) intervention, and response to late percutaneous coronary intervention of the infarct related artery (IRA).
Detailed description
BACKGROUND:
Coronary heart disease is a major health problem in the United States. It is estimated that in 2003, more than 600,000 Americans had a new heart attack, and more than 400,000 experienced a recurrent heart attack. Up to 40% of individuals with a new or recurrent heart attack will show a complete occlusion, or blocking, of the IRA on follow-up angiography. Many people with an occluded IRA post-heart attack are at risk for progressive LV remodeling in the heart, which can lead to congestive heart failure.
The NHLBI-funded OAT study is testing the hypothesis that opening an occluded IRA 3 to 28 days following a heart attack will reduce the composite endpoint of mortality, recurrent heart attack, and New York Heart Association class IV heart failure over a three-year follow-up period. OAT has enrolled approximately 1,100 participants at 240 centers in 24 countries. Among the mechanisms proposed to explain the benefit of late revascularization, recovery of LV function and attenuation of LV remodeling due to restoration of blood flow to viable myocardium, or heart muscle, is the most plausible.
DESIGN NARRATIVE:
An estimated 200 individuals who have had a heart attack will be enrolled in this study. The primary aims of this study are the following: 1) to test the hypothesis that participants who demonstrate preservation of viability within the infarct zone will have less progressive remodeling compared to participants exhibiting predominant infarct, and 2) to test the hypothesis that preservation of viability will modify the treatment effect of randomization to late revascularization in participants with an occluded IRA 3 to 28 days after the heart attack. All participants will have resting gated Tc-99m sestamibi SPECT imaging at baseline, and again 1 year later. Parameters of baseline viability within the infarct zone, and serial measures of LV volume change and function will be centrally assessed by the Cardiac Imaging Core Laboratory at Tufts Medical Center. The major study endpoint to address the hypotheses will be serial change in LV end-diastolic volume, based on the degree of preservation of viability within the defined infarct zone. Sample size calculations will be based on data evaluated by the same group from a similar number of participants studied at a similar number of clinical sites.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People who have experienced a heart attack 3 to 28 days prior to study entry.
Key inclusion criteria (2 listed)
- Has experienced a heart attack 3 to 28 days prior to study entry
- Has an occluded IRA at catheterization
Key exclusion criteria (0 listed)
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
The primary end point of LV remodeling was assessed by change in LV EDV from baseline to 1 year.
Time frame: 1 year
The primary end point of LV remodeling was assessed by change in LV EDV from baseline to 1 year.
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 27 Apr 2017.
- Individual participant dataSharing planned: No
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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.
James E. Udelson study chair
Tufts Medical Center
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 Tufts Medical Center 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 2 inclusion and 0 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 27 Apr 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.
What does the primary outcome measure?
The primary end point of LV remodeling was assessed by change in LV EDV from baseline to 1 year. (time frame: 1 year). It is what the study was designed to measure, not a finding.
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 27 Apr 2017.