Pre-hospital Administration of Thrombolytic Therapy With Urgent Culprit Artery Revascularization
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/14/2017 |
| Start Date: | November 2003 |
| End Date: | March 2014 |
PATCAR Pilot Trial: A Phase 4 Study, Pre-hospital Administration of Thrombolytic Therapy With Urgent Culprit Artery Revascularization
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.
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.
To demonstrate feasibility of the project in a pilot trial we plan to enroll up to 500
patients to pre-hospital thrombolysis/clot 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 and/or
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,
ECG's will be obtained at hospital discharge/transfer. All patients will follow the current
standard of care for STEMI/heart 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.
patients to pre-hospital thrombolysis/clot 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 and/or
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,
ECG's will be obtained at hospital discharge/transfer. All patients will follow the current
standard of care for STEMI/heart 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.
Inclusion Criteria:
1. Ischemic discomfort (squeezing, crushing, or pressure, sub-sternal, unrelated to
breathing or movement), epigastric discomfort or pre-syncopal symptoms with
diaphoresis, lasting > 30 minutes.
2. ST elevation > 0.1 mV in 2 or more contiguous limb leads or > 0.2 mV in 2 or more
contiguous pre-cordial leads.
3. Less than 6 hours after onset of sustained chest pain.
4. Age 18 years or older.
Exclusion Criteria:
1. Chest pain described as ripping or tearing, radiating to the back and/or down the leg,
and/or systolic blood pressure > 15 mmHg difference in each arm.
2. Suspected cocaine or amphetamine use within previous 3 days.
3. Known or suspected pregnancy.
4. Cardiac arrest requiring intubation.
5. Cardiac arrest requiring greater than 20 minutes CPR.
6. Coronary intervention (PTCA/stent/CABG) within previous 4 weeks.
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