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

September 12, 2005
May 2, 2013
November 2003
December 2012   (final data collection date for primary outcome measure)
Mortality and re-infarction rate at six months after trial entry [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Mortality and re-infarction rate at six months after trial entry - Group A (pre-hospital thrombolytic therapy followed by admission to the CCU) vs. Group B (pre-hospital thrombolytic therapy followed by emergent culprit artery stenting (Group B).
Complete list of historical versions of study NCT00178620 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 1. Mortality Group A vs. Group B.
  • 2. Mortality Group B (High Risk) (HR LV Assist vs. HR Usual Care)
  • 3. Mortality and re-infarction rate Group A vs. Group D.
  • 4. Mortality and re-infarction rate Group B vs. Group D.
  • 5. Bleeding complications (including ICB, need for transfusion, or need for surgery) Group A vs. Group B.
  • 6. Bleeding complications Group A vs. Group D.
  • 7. Bleeding complications Group B vs. Group D.
  • 8. Combined Endpoint in matched patients (thrombolytic ineligible) Group C vs. Group D.
  • 9. Economic analysis Group A vs. Group B. Economic analysis Group B vs. Group D. Subgroup analysis of Combined Endpoint in A) Rural (Spoke) hospital cohort: Group A vs. Group B and B) Urban (Hub) hospital cohort: Group A vs. Group B.
Not Provided
Not Provided
 
Pre-hospital Administration of Thrombolytic Therapy With Urgent Culprit Artery Revascularization
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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Heart Disease
  • Myocardial Infarction
  • Acute Myocardial Infarction
  • 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.
  • Active Comparator: I
    Retavase 10 U IV Bolus
    Interventions:
    • Drug: Retavase 10 U IV Bolus
    • Procedure: Angioplasty/Heart Catheterization
    • Device: Drug eluting stent placed in heart attack related artery
  • II
    Interventions:
    • Procedure: Angioplasty/Heart Catheterization
    • Device: Drug eluting stent placed in heart attack related artery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
254
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00178620
PATCAR Pilot Trial HSC 03-021
Yes
Richard Smalling, The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
Not Provided
Principal Investigator: Richard W. Smalling, MD, PhD The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP