A prospective, observational, multicenter study comparing Tenecteplase facilitated PCI versus primary PCI in Indian patients with STEMI

This is a study comparing 2 treatment options that are available and practiced for the treatment for STEMI.  There will be no treatment assigned for the study and no intervention done for the study . Data will be collected on an observational basis from patients who undergo primary PCI and from patients who receive facilitated PCI for the same condition**.**xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

Primary objective:

The primary objective of this study is to assess theefficacy of prompt fibrinolysis coupled with contemporary antiplatelet and antithrombotic therapy at first medical contact followed by timely catheterization or rescue coronary intervention in STEMI patients within 12 hours of symptom onset versus a strategy of Standard Primary Percutaneous Coronary I

Study hypothesis:

Primary Percutaneous Coronary Intervention in Acute Myocardial Infarction is a preferred mode of revascularization as compared to thrombolytic therapy.  There is no primary data on Primary Percutaneous Coronary Intervention Vs TNK facilitated Percutaneous Coronary Intervention. In Indian context TNK facilitated PCI (Pharmacoinvasive therapy) is a more practical solution.  This study aims to confirm the efficacy and safety of Primary PCI Vs Pharmacoinvasive therapy in 200 patients across 8 centers.

Serious Adverse Events:

Centre Name: Kovai medical Centre,Coimbatore

Principal Investigator: Dr.Thomas Alexender

SAE reported : Cardiogenic shock

SAE reported on : 02 -Oct-2011

SAE out come : Death

Causal relation with treatment : not applicable

SAE narrative:

60 years old patient was admitted with compliance of chest pain ,breathlessness on 29-O9-2011, ECG was performed and the result  showed ST elevation .

Patient was considered for the study and hence screened. Preangioplasty angiogram revealed total occlution of the LAD proxiamlly which was Stented with drug eluting stent .During the procedure patient had bradycardia and bundle branch block for which the patient was put on temporary pacing and Ionotropic support.Patient was intubated and ventilatedfor persistent and worsening hypoxemia.patient was having persistant hypotension and requring multiple inotropic support. on 02-10-2011 at 9:15 am patient had asystolic cardiac arrest .CPR started as per the ACLS protocol .Inspite of all resuscitative efforts patient could not be revieved and declared death at 09:27 am on 02-10-2011