Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00430612
Status:
COMPLETED
Last Update Posted:
2023-04-24
First Post:
2007-01-31
Brief Title:
The PACE-MI Registry Study - Outcomes of Beta-blocker Therapy After Myocardial Infarction OBTAIN
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
The PACE-MI Registry Study - Outcomes of Beta-blocker Therapy After Myocardial Infarction OBTAIN
Status:
COMPLETED
Status Verified Date:
2023-04
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:
OBTAIN
Brief Summary:
The purpose of the PACE-MI OBTAIN registry is
Analyze beta-blocker dose response effect on outcome over two years
Explore gender and minority differences in beta-blocker utilization and outcomes
In patients with Myocardial Infarction MI discharged from the hospital beta-blocker dose will be predictive of survival
Exploratory analyses Gender and racial effects-gender and race are similarly hypothesized to be predictive of post-MI survival
The existence of interactions between gender and beta-blocker effect as well as race and beta-blocker effect will also be evaluated
Analyze beta-blocker dose response effect on outcome over two years
Explore gender and minority differences in beta-blocker utilization and outcomes
In patients with Myocardial Infarction MI discharged from the hospital beta-blocker dose will be predictive of survival
Exploratory analyses Gender and racial effects-gender and race are similarly hypothesized to be predictive of post-MI survival
The existence of interactions between gender and beta-blocker effect as well as race and beta-blocker effect will also be evaluated
Detailed Description:
Methods
All patients admitted to the coronary care areas with an acute myocardial infarction will be entered into the registry At the time of discharge from the coronary care unit clinical data will be entered The registry will include approximately 6800 patients
As there is no intervention in the registry the data to be collected are standard for quality assurance purposes and cannot practicably be carried out without waivers of consent and HIPAA authorization there will be no consent specifically for registry patients at baseline Systems have been implemented to ensure the registry data will remain confidential Sites have received IRB approval of waiver of consent and HIPAA for the baseline registry data
Data to be collected will include demographic including ethnic and race classifications according to NIH guidelines data and information regarding the index myocardial infarction Use of beta-blockers at discharge from the coronary care unit will be documented In addition beta-blocker use at hospital discharge will be noted Data for the registry will be obtained from ER notes admission notes cardiac catheterization lab reports medication lists lab reports and discharge summaries
Follow-Up
Follow-up for registry patients will be conducted at year 1 and year 2 post-myocardial infarction Data may be obtained via medical chart review phone contact and Social Security Death Index SSDI For follow-up information obtained via chart review or the SSDI a detailed justification for waiver of HIPAA and consent requirements is attached to this protocol If phone contact is required with the patient we are suggesting the following process
A letter should be sent out to the patient approximately one week prior to the contact in which the rationale for the study will be provided as well as a delineation of the patients right to participate or not to participate by either providing or not providing the requested information
At telephone contact with the patient the coordinator will document whether the patient consents to provide the information If the patient consents the coordinator will proceed to obtain the requested information
In the event that the participating institutions IRB requires a written signed consent for this verbal contact a written consent form template is provided
Data collected at follow-up interview will include vital status beta-blocker use other cardiac medications and any cardiovascular hospitalizations
All patients admitted to the coronary care areas with an acute myocardial infarction will be entered into the registry At the time of discharge from the coronary care unit clinical data will be entered The registry will include approximately 6800 patients
As there is no intervention in the registry the data to be collected are standard for quality assurance purposes and cannot practicably be carried out without waivers of consent and HIPAA authorization there will be no consent specifically for registry patients at baseline Systems have been implemented to ensure the registry data will remain confidential Sites have received IRB approval of waiver of consent and HIPAA for the baseline registry data
Data to be collected will include demographic including ethnic and race classifications according to NIH guidelines data and information regarding the index myocardial infarction Use of beta-blockers at discharge from the coronary care unit will be documented In addition beta-blocker use at hospital discharge will be noted Data for the registry will be obtained from ER notes admission notes cardiac catheterization lab reports medication lists lab reports and discharge summaries
Follow-Up
Follow-up for registry patients will be conducted at year 1 and year 2 post-myocardial infarction Data may be obtained via medical chart review phone contact and Social Security Death Index SSDI For follow-up information obtained via chart review or the SSDI a detailed justification for waiver of HIPAA and consent requirements is attached to this protocol If phone contact is required with the patient we are suggesting the following process
A letter should be sent out to the patient approximately one week prior to the contact in which the rationale for the study will be provided as well as a delineation of the patients right to participate or not to participate by either providing or not providing the requested information
At telephone contact with the patient the coordinator will document whether the patient consents to provide the information If the patient consents the coordinator will proceed to obtain the requested information
In the event that the participating institutions IRB requires a written signed consent for this verbal contact a written consent form template is provided
Data collected at follow-up interview will include vital status beta-blocker use other cardiac medications and any cardiovascular hospitalizations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| U01HL080416 | NIH | None | httpsreporternihgovquickSearchU01HL080416 |