Pre-hospital Administration of Thrombolytic Therapy With Urgent Culprit Artery Revascularization (PATCAR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Richard Smalling, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00178620
First received: September 12, 2005
Last updated: May 2, 2013
Last verified: May 2013
  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
Myocardial Infarction
Acute Myocardial Infarction
Drug: Retavase 10 U IV Bolus
Procedure: Angioplasty/Heart Catheterization
Device: Drug eluting stent placed in heart attack related artery
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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:


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 ]

Enrollment: 254
Study Start Date: November 2003
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: I
Retavase 10 U IV Bolus
Drug: Retavase 10 U IV Bolus
Retavase IV Bolus, 10 U, one dose at time of myocardial infarction
Other Name: Thrombolytic-clot busting drug
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.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Texas
Memorial Hermann Hospital / The University of Texas HSC
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Richard W. Smalling, MD, PhD The University of Texas Health Science Center, Houston
  More Information

Additional Information:
No publications provided

Responsible Party: Richard Smalling, Professor - Internal Medicine, Cardiology, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00178620     History of Changes
Other Study ID Numbers: PATCAR Pilot Trial HSC 03-021
Study First Received: September 12, 2005
Last Updated: May 2, 2013
Health Authority: 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:
Infarction
Heart Diseases
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Cardiovascular Diseases
Myocardial Ischemia
Vascular Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on September 18, 2014