A local feasibility study of mangafodipir as an adjunct to percutaneous coronary intervention in patients with acute myocardial infarction - MANAMI PP01-99

Conditions: Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Patients with acute myocardial infarction decided for treatment by percutaneous coronary intervention (PCI) are included. The test drug mangafodipir is administered intravenously just prior to PCI. The objective is to prevent reperfusion injury on return of blood flow to the ischemic myocardium. If mangafodipir proves successful, the infarct size will be smaller, and the condition of the patient improved during the acute phase and thereafter

Registration Number: EUCTR2009-011485-28-SE

Lead Sponsor: PledPharma AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

a. Males 40-80 years and females 50-80 years with AMI ( acute myocardial infarction)
b. Chest pain up to 6 hours.
c. ST segment elevation in two neighbouring leads in the anterior wall (= 0.2 mV) or in the inferior wall (= 0.1 mV) of the left ventricle.
d. Decided for treatment by primary PCI.
e. TIMI grade 0 flow in the occluded LAD/RCA artery
f. Written informed consent.

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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

a. Previous coronary artery bypass operation.
b. Previous AMI.
c. Chest pain more than 6 hours.
d. Angina within 48 hours before admission.
e. Cardiac arrest and cardiogenic shock.
f. Occlusion of other coronary arteries than LAD.
g. Known hypersensitivity to mangafodipir (as contrast agent for MRI).
h. Received mangafodipir = 5 weeks before admission
i. History of prior serious allergic or pseudo-allergic reaction
j. Severely reduced liver or renal function
k. Any other serious illness or medical condition
l. Fertile females
m. Phaeochromocytoma
n. Thrombolytic treatment applied before primary PCI

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of the present trial is to find out whether mangafodipir, being a potent cardioprotective drug in animal studies, prevents reperfusion injury and reduces infarct size in patients during acute myocardial infarction. ;Secondary Objective: To find out whether mangafodipir given as a therapeutic adjunct to primary coronary intervention (primary PCI) reduces postischemic release to plasma of biomarkers of myocardial injury and reduces myocardial infarct size assessed by cardiac MRI at about 2 months following the acute heart attack.;Primary end point(s): The primary end-point will be release of biomarkers (CK-MB and Troponin T) to plasma at 6 hours after PCI. ;Timepoint(s) of evaluation of this end point: 6 hours after PCI

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary end-points will be accumulated plasma CK-MB and cTnT over 48 hours after PCI<br>Regression of ST segment elevation at end of ichemia measured at 6 and 48 hours after reperfusion and expressed in mV and assessment of infarct size and cardiac function by MRI at 6-10 weeks after AMI;Timepoint(s) of evaluation of this end point: over 48 hours after PCI, after 6 and 48 hours after reprefussion and at 6-10 weeks after AMI