Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00178620
Status:
COMPLETED
Last Update Posted:
2023-09-06
First Post:
2005-09-12
Brief Title:
Pre-hospital Administration of Thrombolytic Therapy With Urgent Culprit Artery Revascularization
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
PATCAR Pilot Trial A Phase 4 Study Pre-hospital Administration of Thrombolytic Therapy With Urgent Culprit Artery Revascularization
Status:
COMPLETED
Status Verified Date:
2023-08
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:
PATCAR
Brief Summary:
The PATCAR study has been designed to test the hypothesis that the strategy of pre-hospital use of a clot busting thrombolytic drug followed with emergent heart catheterization including stenting of the problematic coronary artery will result in a lower mortality and reduced repeat heart attack rates
Early identifying and treating heart attacks patients prior to the arriving at the hospital in those patients who qualify for the clot busting drugs will lower the size of the heart attack damage This smaller heart attack will lead to fewer problems with less repeat heart attacks and death in the future
Early identifying and treating heart attacks patients prior to the arriving at the hospital in those patients who qualify for the clot busting drugs will lower the size of the heart attack damage This smaller heart attack will lead to fewer problems with less repeat heart attacks and death in the future
Detailed Description:
To demonstrate feasibility of the project in a pilot trial we plan to enroll up to 500 patients to pre-hospital thrombolysisclot busting followed by emergent catheterization and stenting of the problematic or culprit artery
This will comprise an EMS system capable of performing pre-hospital ECGs followed by emergent transportation to a Level I Cardiovascular Center where the patients will be taken to urgent cardiac catheterization and emergent stenting of the culprit artery
Patients identified as having typical symptoms of acute MI and an ECG consistent with acute ST elevation MI will be screened in the field by paramedics or in the spoke hospitals by the ED attending physicians using the screening form Verbal Consent will be obtained for receiving acute therapy for their MI as outlined in the protocol After therapy is initiated in the field or at the spoke hospital the patients will be transported as quickly as possible to the receiving Level I Cardiovascular Center Hub Hospital The ED personnel in the Level I Cardiovascular Center will have activated the Interventional Cardiovascular Team and the Cath Lab personnel after having received the initial qualifying transmitted ECG
Once the patient arrives informed consent will be obtained by the ED investigator andor in-house Cardiology fellow for enrollment in the PATCAR Trial Thrombolytic ineligible patients will also be collect for this study and also go directly to the Cath Lab for PCI Study coordinators will enter the data into the Case Report Forms and forward the completed forms to Westat-ALA for data capture in the database In addition to the qualifying ECG ECGs will be obtained at hospital dischargetransfer All patients will follow the current standard of care for STEMIheart attacks patients Patients will have a Cardiac MRI done on day 3 or 5 of their hospital stay to measure the size and amount of damage the heart suffered as a result of their Heart attack
This will comprise an EMS system capable of performing pre-hospital ECGs followed by emergent transportation to a Level I Cardiovascular Center where the patients will be taken to urgent cardiac catheterization and emergent stenting of the culprit artery
Patients identified as having typical symptoms of acute MI and an ECG consistent with acute ST elevation MI will be screened in the field by paramedics or in the spoke hospitals by the ED attending physicians using the screening form Verbal Consent will be obtained for receiving acute therapy for their MI as outlined in the protocol After therapy is initiated in the field or at the spoke hospital the patients will be transported as quickly as possible to the receiving Level I Cardiovascular Center Hub Hospital The ED personnel in the Level I Cardiovascular Center will have activated the Interventional Cardiovascular Team and the Cath Lab personnel after having received the initial qualifying transmitted ECG
Once the patient arrives informed consent will be obtained by the ED investigator andor in-house Cardiology fellow for enrollment in the PATCAR Trial Thrombolytic ineligible patients will also be collect for this study and also go directly to the Cath Lab for PCI Study coordinators will enter the data into the Case Report Forms and forward the completed forms to Westat-ALA for data capture in the database In addition to the qualifying ECG ECGs will be obtained at hospital dischargetransfer All patients will follow the current standard of care for STEMIheart attacks patients Patients will have a Cardiac MRI done on day 3 or 5 of their hospital stay to measure the size and amount of damage the heart suffered as a result of their Heart attack
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