Acute Myocardial Infarction MedDRA version: 20.0 Level: PT Classification code 10000891 Term: Acute myocardial infarction System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: Anxut 5 mg
Product Name: Buspirone Hydrochloride
Pharmaceutical Form: Tablet
INN or Proposed INN: Anxut 5 mg
CAS Number: 333
Sponsors
ZOLL, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All Inclusion Criteria must be answered YES for subject to satisfy Inclusion Criteria: 1. The patient is = 18 years of age 2. The patient must have symptoms consistent with AMI (i.e. chest pain, arm pain, etc.) and unresponsive to nitroglycerin, with symptoms beginning greater than 30 minutes but less than 6 hours prior to presentation at hospital. 3. Qualifying Infarct location: Evidence of Acute Anterior MI only with ST-segment elevation of = 0,2 mV in two or more anterior contiguous precordial leads. 4. The patient is eligible for PCI. 5. The patient is willing to provide written informed consent to participate in this clinical trial. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 368 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: All Exclusion Criteria must be answered NO for subject to satisfy Exclusion Criteria: 1. The patient has had a previous Myocardial Infarction. 2. The patient is experiencing cardiogenic shock (systolic blood pressure [SBP] 37.5 °C) or has experienced an infection with fever in the last 5 days. 7. The patient has a known previous CABG. 8. The patient has a known recent stroke within 90 days of admission. 9. Cardio-pulmonary decompensation that has occurred en route to the hospital or, in the opinion ofthe physician, that is imminent or likely to occur following presentation to the clinical site. 10. Contraindications to hypothermia, such as patients with known hematologic dyscrasias which affect thrombosis (e.g., cryoglobulinemia, sickle cell disease, serum cold agglutinins) or vasospastic disorders (such as Raynaud's or thromboangitis obliterans).The patient has a known hypersensitivity or contraindication to aspirin, heparin, or sensitivity to contrast media, which cannot be adequately pre-medicated. 11. Any contraindication to cardiac MRI, or any implant in the upper body which may cause artifacts on cardiac MRI imaging. 12. The patient has a known hypersensitivity or contraindication to aspirin, heparin, or sensitivity to contrast media, which cannot be adequately pre-medicated. 13. The patient has a known history ofbleeding diathesis, coagulopathy, cryoglobulinemia, sickle cell anemia, or will refuse blood transfusions. 14. The patient has a height of <1.5 meters (4 feet 11 inches). 15. The patient has a known hypersensitivity or contraindication to buspirone hydrochloride or Pethidine (Meperidine) and/or has been treated with a monoamine oxidase inhibitor in the past 14 days. 16. Patient has a known history of severe hepatic or renal impairment, untreated hypothyroidism, Addison's disease, benign prostatic hypertrophy, or urethral stricture that in the opinion ofthe physician would be incompatible with Pethidine administration. 17. The patient has an Inferior Vena Cava filter in place (IVC). 18.The patient has a pre-MI life expectancy of <1 year due to underlying medical conditions or pre-existing co-morbidities. 19. The patient has a known, unresolved history of drug use or alcohol dependency, or lacks the ability to comprehend or follow instructions. 20. The patient is currently enrolled in another investigational drug or device trial. 21. The patient is apprehensive about or unwilling to undergo the required MRI imaging at fol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this trial is to evaluate the safety and effectiveness of therapeutic hypothermia, using the ZOLL Proteus IVTM System, as an adjunctive therapy for patients presenting with acute anterior myocardial infarction (AMI) and undergoing percutaneous coronary intervention (PCI).;Secondary Objective: Not applicable;Primary end point(s): Relative reduction of 20% in mean anterior myocardial infarct size as determined by Cardiac Magnetic Resonance (cMR) imaging at 4-6 days post infarct in the Test Arm (cooling+ PCI) relative to the Control Arm (PCI only).;Timepoint(s) of evaluation of this end point: During and at the end of the observation period (4-6 days post infarct). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Per-patient rate of composite endpoint of Major Adverse Cardiac Events (MACE) in randomized subjects, defined as Cardiac Death, all Myocardial Infarction and Clinically-Indicated Target Lesion Revascularization at 30 day follow-up period.;Timepoint(s) of evaluation of this end point: 30 day follow-up | — |
Countries
Austria, Bosnia and Herzegovina, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Italy, Latvia, Macedonia, the former Yugoslav Republic of, Poland, Portugal, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom
Contacts
Public ContactClinical Affairs
ZOLL Medical
Outcome results
None listed