Acute Myocardial Infarction, Heart Disease, Myocardial Infarction
Conditions
Keywords
Heart Disease, Heart Attack, Myocardial Infarction, Thrombolytic Therapy, Emergency Medicine
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.
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.
Interventions
Thrombolytic-clot busting drug Retavase IV Bolus, 10 U followed by a second 10U dose
DRUGReteplase 10 U
Thrombolytic-clot busting drug Retavase IV Bolus in one 10U dose
PROCEDUREUrgent Percutaneous Coronary Intervention (PCI)
PROCEDUREPrimary Percutaneous Coronary Intervention (PCI)
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality at 30 Days | 30 day |
Secondary
| Measure | Time frame |
|---|---|
| Infarction Size as Measured by Cardiac Magnetic Resonance Imaging (MRI) | 1 year |
| Reduction in Time From Onset of Pain to Reperfusion | 1 year |
| Angiographic Documentation of Reperfusion | 1 year |
| Electrocardiogram (ECG) ST Segment Elevation Recovery | 1 year |
Countries
United States
Participant flow
Recruitment details
All ACS patients 18 years or older with documented STEMI on EKG, who presented within 6 hours of onset of sustained chest pain, and met all eligibility criteria, were enrolled in PATCAR after an informed consent was obtained.
Participants by arm
| Arm | Count |
|---|---|
| Group A Full dose, pre-hospital fibrinolysis followed by treatment in the coronary care unit. | 37 |
| Group B One-half dose pre-hospital reteplase followed by urgent PCI | 253 |
| Group C Fibrinolytic ineligible patients who were treated with primary PCI at the STEMI center. | 37 |
| Group D Patients not transported by participating EMS units transferred in and treated with primary PCI at the STEMI center. | 63 |
| Total | 390 |
Baseline characteristics
| Characteristic | Group A | Group B | Group C | Group D | Total |
|---|---|---|---|---|---|
| Age, Customized <=18 years | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Age, Customized >=65 years | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Age, Customized Between 18 and 65 years | 37 participants | 253 participants | 37 participants | 63 participants | 390 participants |
| Sex: Female, Male Female | 6 Participants | 69 Participants | 17 Participants | 14 Participants | 106 Participants |
| Sex: Female, Male Male | 31 Participants | 184 Participants | 20 Participants | 49 Participants | 284 Participants |
| Treatment Allocation by Group | 37 participants | 253 participants | 37 participants | 63 participants | 390 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 37 | 0 / 253 | 0 / 37 | 0 / 63 |
| serious Total, serious adverse events | 0 / 37 | 9 / 253 | 4 / 37 | 0 / 63 |
Outcome results
Primary
Mortality at 30 Days
Time frame: 30 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A | Mortality at 30 Days | 1 participants |
| Group B | Mortality at 30 Days | 7 participants |
| Group C | Mortality at 30 Days | 3 participants |
| Group D | Mortality at 30 Days | 2 participants |
Secondary
Angiographic Documentation of Reperfusion
Time frame: 1 year
Population: Data were not collected for this outcome measure.
Secondary
Electrocardiogram (ECG) ST Segment Elevation Recovery
Time frame: 1 year
Population: Data were not collected for this outcome measure.
Secondary
Infarction Size as Measured by Cardiac Magnetic Resonance Imaging (MRI)
Time frame: 1 year
Population: Data were not collected for this outcome measure.
Secondary
Reduction in Time From Onset of Pain to Reperfusion
Time frame: 1 year
Population: Data were not collected for this outcome measure.