Pre-hospital Administration of Thrombolytic Therapy With Urgent Culprit Artery

Revascularization (PATCAR)
This study is currently recruiting participants.
Verified by The University of Texas Health Science Center, Houston, August 2010
First Received: September 12, 2005   Last Updated: August 3, 2010   History of Changes

The University of Texas

Sponsor: Health Science Center,
Houston

The University of Texas

Information
Health Science Center,
provided by:
Houston

ClinicalTrials.
NCT00178620
gov Identifier:

  Purpose

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.

Condition Intervention Phase

Heart Disease Drug: Retavase 10 U IV Bolus Phase
Myocardial Procedure: Angioplasty/Heart IV
Infarction Catheterization
Acute Myocardial Device: Drug eluting stent placed in heart
Infarction attack related artery

Study Type: Interventional

Study Allocation: Non-Randomized
Design: Control: Uncontrolled
 Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Official Title: PATCAR Pilot Trial: A Phase 4 Study, Pre-hospital Administration of

Thrombolytic Therapy With Urgent Culprit Artery Revascularization

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty Heart Attack Heart Diseases

Drug Information available for: Reteplase
U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:

 Mortality and re-infarction rate at six months after trial entry [ Time Frame: 1 year ]
[ Designated as safety issue: No ]

Secondary Outcome Measures:

 Safety and bleeding complications (including intracranial bleeding (ICB), need for
transfusion, or need for surgery) [ Time Frame: 1 year ]
[ Designated as safety issue: Yes ]
 Infarction size as measured by cardiac magnetic resonance imaging (MRI)
[ Time Frame: 1 year ] [ Designated as safety issue: No ]
 Reduction in time from onset of pain to reperfusion [ Time Frame: 1 year ]
[ Designated as safety issue: No ]
 Angiographic documentation of reperfusion [ Time Frame: 1 year ]
[ Designated as safety issue: No ]
 Electrocardiogram (ECG) ST segment elevation recovery [ Time Frame: 1 year ]
[ Designated as safety issue: No ]

Estimated Enrollment: 500

Study Start Date: November 2003

Estimated Study Completion Date: December 2010

Estimated Primary Completion Date: December 2010 (Final data collection date for primary
outcome measure)

Arms Assigned Interventions

I: Active Drug: Retavase 10 U IV Bolus
Comparator Retavase IV Bolus, 10 U, one dose at time of myocardial infarction
Retavase 10 Procedure: Angioplasty/Heart Catheterization
U IV Bolus
Candidates will receive all the approved standard therapy for heart attacks
patients and will go directly for emergent heart catheterization.

Following local anesthesia, a small flexible tube (catheter) will be inserted in

an artery of your leg and advanced to the arteries of your heart. By injecting x-
ray contrast through the catheter, any blockage in the artery can be seen. If your
heart attack artery is still blocked by blood clot or cholesterol deposits, it will
be opened up by angioplasty ("balloon surgery" procedure to open the blocked
artery) and stenting (placement of a slotted metal tube in the artery to prevent it
from closing on itself).
Device: Drug eluting stent placed in heart attack related artery
Stents will be placed (if needed) during the end of the angioplasty/heart
catheterization.

II Procedure: Angioplasty/Heart Catheterization

Candidates will receive all the approved standard therapy for heart attacks
patients and will go directly for emergent heart catheterization.

Following local anesthesia, a small flexible tube (catheter) will be inserted in

an artery of your leg and advanced to the arteries of your heart. By injecting x-
ray contrast through the catheter, any blockage in the artery can be seen. If your
heart attack artery is still blocked by blood clot or cholesterol deposits, it will
be opened up by angioplasty ("balloon surgery" procedure to open the blocked
artery) and stenting (placement of a slotted metal tube in the artery to prevent it
from closing on itself).
Device: Drug eluting stent placed in heart attack related artery
Stents will be placed (if needed) during the end of the angioplasty/heart
catheterization.

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years and older

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00178620

Contacts
Contact: Amol B Rajmane,
713-500-6563 Amol.Rajmane@uth.tmc.edu
MBBS,MS

Locations

United States, Texas

Memorial Hermann Hospital / The University of Texas HSC Recruiting
Houston, Texas, United States, 77030
Contact: Amol B Rajmane, MBBS,MS     713-500-6563    
Amol.Rajmane@uth.tmc.edu    
Principal Investigator: Richard W. Smalling, MD, PhD            
Sub-Investigator: James J. McCarthy, MD            
Sub-Investigator: H. Vernon Anderson, MD            
Sub-Investigator: Ali E. Denktas, MD            
Sub-Investigator: Stefano Sdringola, MD            
Sub-Investigator: David E. Persse, MD            
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Richard W. Smalling, The University of Texas Health Science
Investigator: MD, PhD Center, Houston
  More Information

Additional Information:
The University of Texas Health Science Center Web Site 

No publications provided

Responsible Party: University of Texas Medical School at Houston ( Richard

Smalling, MD, PhD )
ClinicalTrials.gov NCT00178620     History of Changes
Identifier:
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:
PATCAR Pilot Trial HSC 03-021
September 12, 2005
August 3, 2010
United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center, Houston:

Heart Disease
Heart Attack
Myocardial Infarction
Thrombolytic Therapy
Emergency Medicine

Additional relevant MeSH terms:

Heart Diseases Fibrinolytic Agents
Myocardial Infarction Reteplase
Infarction Fibrin Modulating Agents
Cardiovascular Diseases Molecular Mechanisms of Pharmacological
Ischemia Action
Pathologic Processes Pharmacologic Actions
Necrosis Cardiovascular Agents
Myocardial Ischemia Therapeutic Uses
Vascular Diseases Hematologic Agents

ClinicalTrials.gov processed this record on September 15, 2010