Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00099411
Status:
COMPLETED
Last Update Posted:
2017-04-27
First Post:
2004-12-13
Brief Title:
Heart Muscle Viability and Remodeling in Individuals Post-Heart Attack
Sponsor:
Tufts Medical Center
Organization:
Tufts Medical Center
Study Overview
Official Title:
Myocardial Viability and Remodeling in the Occluded Artery Trial OAT-Ancillary to OAT
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 600000 Americans had a new heart attack and more than 400000 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 1100 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
Coronary heart disease is a major health problem in the United States It is estimated that in 2003 more than 600000 Americans had a new heart attack and more than 400000 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 1100 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL075456 | NIH | None | httpsreporternihgovquickSearchR01HL075456 |