Acute Myocardial Infarction with ST elevation. ST elevation (STEMI) myocardial infarction of unspecified site
Conditions
Interventions
Intervention 1: Intervention group 1: This group will receive thrombolytic therapy using Altelyse ( Alteplase made by Arena Hayat Danesh Co). People weighing more than 67kg will receive 15 mg bolus, 5
Sponsors
Arena Life Science Company
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Chest pain compatible with ischemic heart disease for more than 20 minutes Start of symptoms of Acute Myocardial Infarction (Peak of chest pain) 12 hours (Maximum) before thrombolytic treatment Signs of Acute Myocardial Infarction in Electrocardiogram: ST elevation of 0.1 mili-volt or more in two adjacent leads other than v2 and v3; ST elevation of 0.25 mili-volt or more in v2 and v3 leads in men younger than 40 years; ST elevation of 0.2 mili-volt or more in v2 and v3 leads in men older than 40 years; ST elevation of 0.15 mili-volt or more in v2 and v3 leads in women irrespective of their age. Lack of access to cath lab to do PPI, Primary Per-cutaneous Coronary Intervention or expecting a delay more than 2 hours between between first medical contact and performance of first balloon dilatation excluding the time takes from first medical contact till the start of thrombolytic therapy. Signed informed consent Age of 18 years or more
Exclusion criteria
Exclusion criteria: Presence of left bundle block in electrocardiogram Presence of accompanying severe diseases such as renal failure (GFR180 mm Hg or diastolic BP > 110 mm Hg Transient ischemic attack in the preceding 6 months Dementia Pregnancy or within 1 week postpartum Internal bleeding within the last 2-4 weeks Active peptic ulcer Infectious endocarditis Cardiopulmonary resuscitation that has caused injury to the chest or lasted more than 10 minutes Patients who receive anticoagulant therapy such as warfarin Advanced liver disease Known intracranial lesions other than those listed as absolute contraindications for thrombolytic therapy Diabetic Hemorrhagic Retinopathy or other hemorrhagic ophthalmic conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of ST resolution (STR) at 90 minutes. Timepoint: 90 minutes after start of thrombolytic therapy. Method of measurement: To estimate percentage of ST resolution at 90 minutes, we will measure the height of ST elevation at 20 milisecond after J point in those leads that have shown elevation of ST in a 12 lead standard ECG at time points 0 and 90. Sum of ST elevations in all 12 leads at 90 minutes will be deducted from the sum of ST elevations at time 0 to work out the total ST resolution (STR) at 90 minutes. We will then calculate the percentage of ST resolution by dividing total STR at 90 minutes to the sum of ST elevations at time 0. In a second measurement approach, percentage of patients who have had more than 50% resolution in their ECG lead with highest ST elevation will be calculated. | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete or partial resolution of ST segment (STR) in 90 minutes. Timepoint: 90 Minutes after thrombolytic therapy. Method of measurement: Complete resolution is defined as 70% resolution in sum of ST elevations and partial resolution is defined as 30 to 70% resolution in sum of ST elevations. Method of calculation of STR is the same as the primary outcome.;Percentage of ST resolution (STR) at 180 minutes. Timepoint: 180 Minutes after thrombolytic therapy. Method of measurement: To estimate percentage of ST resolution at 180 minutes, we will measure the height of ST elevation at 20 milisecond after J point in those leads that have shown elevation of ST in a 12 lead standard ECG at time points 0 and 180. Sum of ST elevations in all 12 leads at 180 minutes will be deducted from the sum of ST elevations at time 0 to work out the total ST resolution (STR) at 180 minutes. We will then calculate the percentage of ST resolution by dividing total STR at 180 minutes to the sum of ST elevations at time 0.;All cause mortality in 30 days. Timepoint: 30 days after intervention. Method of measurement: All deaths irrespective of the cause of death in the first 30 days following thrombolytic therapy starting from the First Medical Contact (FMC) will be counted.;Cardiovascular mortality in 30 days. Timepoint: 30 days after intervention. Method of measurement: All cardiovascular deaths in the first 30 days following thrombolytic therapy starting from the First Medical Contact (FMC) will be counted.;In-hospital mortality due to any cause. Timepoint: Up until discharge from hospital. Method of measurement: All deaths irrespective of their cause up until discharge from hospital will be counted.;Ventricular Ejection Fraction. Timepoint: 2 to 5 days following thrombolytic therapy. Method of measurement: Echocardiography.;Bleeding. Timepoint: After thrombolytic therapy. Method of measurement: All episodes of major and minor bleeding following thrombolytic therapy will be recorded and categ | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHoda Flah Shojaee
Arena Life Science Co.
Outcome results
None listed