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
Conditions
Interventions
Trade Name: Teslascan
Product Name: Mangafodipir
Pharmaceutical Form: Infusion
INN or Proposed INN: MANGAFODIPIR TRISODIUM
CAS Number: 140678-14-4
Concentration unit: mmol/ml millimole(s)/millilitre
C
Sponsors
PledPharma AB
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary end-points will be accumulated plasma CK-MB and cTnT over 48 hours after PCI 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 | — |
Countries
Sweden
Outcome results
None listed