Direct Inhibition of d Protein Kinase C Enzyme to Limit Total Infarct Size in Acute Myocardial Infarction (DELTA MI): Intracoronary KAI-9803 for Injection as an Adjunct to Primary Percutaneous Coronary Intervention for Acute ST Elevation Myocardial Infarction - DELTA MI

• Conditions: Acute myocardial infarction with ST elevation; MedDRA version: 7.1Level: PTClassification code 10000891

• Registration Number: EUCTR2004-005252-14-DE
• Lead Sponsor: KAI Pharmaceuticals Incorporated

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Patients must:-
- have experienced symptoms of cardiac ischemia at rest or with increasing frequency (angina or anginal equivalent) , with episodes lasting for at least 30 minutes within 6 hours of presentation
- have persistent segment elevation of more than 0.2mV in at least 2 contiguous precordial leads indicative of anterior MI location (Leads V1-V4)
- be not less than 18 years old
- have complete occlusion of the left anterior descending artery (TIMI 0-1 flow) demonstrated on the initial angiogram
- other criteria in the protocol
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients must be excluded for:-
- any left bundle branch block (new or old), intraventricular conduction defect, or paced rhythm that would obscure the diagnosis of acute anterior STEMI
- any prior documented MI including old Q waves documented on prior ECGs or a clinical history of definite MI
- any prior coronary artery bypass grafting
- cardiogenic shock at initial presentation, consisting of persistent hypotension (systolic blood pressure < 90 mm Hg for > 20 minutes) and signs of end-organ dysfunction (oliguria, alterred mental status, poor peripheral perfusion or lactic acidosis).
- known baseline serum creatinine > 2.5 mg/dL without renal dialysis or renal replacement therapy within 30 days before presentation
- other criteria in the protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified