Clinical trial of Intracoronary Thrombolysis with Tenecteplase in premature age patients (under 40yrs) with Heart attack.
- Conditions
- Health Condition 1: I219- Acute myocardial infarction, unspecified
- Registration Number
- CTRI/2018/10/016213
- Lead Sponsor
- DR C N MANJUNATH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
(a) Men aged 40 years old or younger
(b) Women aged 40 years old or younger
(c) Presentation to hospital < 6 hours after the index pain.
(d) All patients with diagnosis of STEMI, as evidenced by:
• Detection of a rise and/or fall in cardiac biomarker value (Trop-T), with at least one value above the 99th percentile of the upper reference range and with at least one of the following:
-Symptoms of ischemia
-New or presumed new significant ST-segment T wave (ST-T) changes or new LBBB
-Development of pathologic Q waves on the ECG
-Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality
-Identification of an intracoronary thrombus by angiography
(a)Patients with previous history of ischemic heart disease/ PTCA / CABG.
(b)Patients with history of cardiomyopathy
(c)Patients with mechanical complications of STEMI
(d)Resuscitated Cardiac Arrest, severe LV dysfunction, Kilip-III and IV on presentation to hospital.
(e)Patients with unstable haemodynamics
(f)Patients with absolute contraindications for the use of fibrinolytic agents:
-Any previous intracranial haemorrhage
-Known structural cerebral vascular lesion (e.g., arteriovenous malformation)
-Known malignant intracranial neoplasm (primary or metastatic)
-Ischemic stroke within 3 months except acute ischemic stroke within 4.5 hours
-Suspected aortic dissection
-Active bleeding or bleeding diathesis (excluding menses)
-Significant closed-head or facial trauma within 3 months
-Intracranial or intraspinal surgery within 2 months
-Severe uncontrolled hypertension (unresponsive to emergency therapy)
(g)Patients having a history of diabetes mellitus, chronic alcoholism, concomitant liver, kidney disease, cerebrovascular disease and acute / chronic infection
(e) Patients unwilling to give informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method