Mangafodipir as an Adjunct to Percutaneous Coronary Intervention

NCT00966563 | Completed Phase 2

• 1 other identifier: MANAMI PP01-09
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The present feasibility study is designed to find out whether pre-treatment with the compound mangafodipir (PP-099) provides an additional reduction in myocardial infarct size in patients treated with primary percutaneous coronary intervention (PCI) during acute myocardial infarction (AMI).

Conditions

Myocardial Infarction

Keywords

Mangafodipir; Primary Percutaneous Coronary Intervention; Myocardial infarction; Troponin; CK-MB; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Reduction of myocardial infarct size assessed by biomarker release to plasma

  Before and at 2 days after PCI

Secondary Outcomes (1)

• Reduction of myocardial infarct size assessed by biomarker release to plasma and by magnetic resonance imaging (MRI) of the heart.

  Accumulated biomarker release over 48 hours after PCI; MRI at 6-10 weeks after PCI.

Study Arms (2)

Mangafodipir treatment

ACTIVE COMPARATOR

Treatment will be undertaken with a ready-to use investigative drug formulation identical to what is in diagnostic use as a contrast medium for MRI. Formulation content: MnDPDP 10 mmol/ml.

Drug: Mangafodipir

NaCl 0.9%

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Mangafodipir DRUG

Administered dose: 2 µmol/kg b.w. Administration form: Ready-to-use formulation (solution). Mangafodipir or placebo (0.2 ml/kg b.w.) will be administered as an intravenous (iv.) infusion over 2-5 min prior to reopening of occluded coronary artery during PCI

Also known as: Teslascan

Mangafodipir treatment

Placebo DRUG

NaCl 0.9%

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males 40-80 and females 50-80 years with first severe coronary attack
• Chest pain up to 6 hours.
• T segment elevation (≥ 0.2 mV in two neighbouring anterior and inferior wall leads.
• Decided for treatment by primary PCI.
• TIMI grade 0 flow in the occluded LAD or RCA artery
• Written informed consent.

You may not qualify if:

• Previous coronary artery bypass operation.
• Previous AMI.
• Chest pain more than 6 hours.
• Angina within 48 hours before admission.
• Cardiac arrest and cardiogenic shock.
• Occlusion of the left main stem, circumflex and right coronary arteries at angiography.
• Known hypersensitivity to mangafodipir (as contrast agent for MRI).
• Received mangafodipir ≤ 5 weeks before admission
• History of prior serious allergic or pseudo-allergic reaction
• Severely reduced liver or renal function
• Any other serious illness or medical condition
• Fertile females
• Phaeochromocytoma

Sponsors & Collaborators

• Egetis Therapeutics: lead

Study Sites (1)

Department of Internal Medicine, County Hospital Ryhov

Jönköping, 551 85, Sweden

Location

Related Publications (1)

• 1. Piot C, Croisille P, Staat P, Thibault H, Rioufol G et al. Effect of cyclosporine on reperfusion injury in acute myocardial infarction. New Engl J Med 2008; 359: 473-481. 2. Yellon DM, Hausenloy DJ. Mechanisms of disease: Myocardial reperfusion injury. New Engl J Med 2007; 357: 1121-1135. 3. Karlsson JOG, Brurok H, Eriksen M, Towart R, Toft KG, Moen O, Engebretsen B, Jynge P and Refsum H. Cardioprotective effects of the MR contrast agent MnDPDP and its metabolite MnPLED upon reperfusion of the ischemic porcine myocardium. Acta Radiologica 2001;42:540-547. 4. Brurok H, Ardenkjær-Larsen JH, Hansson G, Skarra S, Berg K, Karlsson JOG, Jynge P. Manganese dipyridoxyl diphosphate: MRI contrast agent with antioxidative and cardioprotective properties. Biochem Biophys Res Commun 1999;254:768-772. 5. Karlsson JOG, Brurok H, Towart R, Jynge P. Letter to the Editor. The magnetic resonance imaging contrast agent mangafodipir exerts antitumor activity via a previously described superoxide mimetic activity. Cancer Res 2006;66:598. 6. MANFOL. Mangafodipir as an adjunct to FOLFOX6 chemotherapy in colon cancer stage Duke's C. Study NCT00671996. 2008. 7. Skjold A, Amundsen BH, Wiseth R, Støylen A, Haraldseth O, Larsson HB, Jynge P. Manganese dipyridoxyl-diphosphate (MnDPDP) as a viability marker in patients with myocardial infarction. J Magn Reson Imaging 2007; 26: 720-727. 8. Jynge P, Brurok H, Asplund A, Towart R, Refsum H, Karlsson JOG. Cardiovascular safety of MnDPDP and MnCl2. Acta Radiol 1997;38:740-749. 9. Karlsson JOG, Mortensen E, Pedersen HK, Sager G, Refsum H. Cardiovasular effects of MnDPDP and MnCl2 in dogs with acute ischemic heart failure. Acta Radiol 1997;38:750-758.

  BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction

Interventions

N,N'-bis(pyridoxal-5-phosphate)ethylenediamine-N,N'-diacetic acid

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Jan-Erik Karlsson, MD, PhD

  Department of Internal Medicine, County Hospital Ryhov, SE-551 85 Jönköping, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2009
• First Posted: August 27, 2009
• Study Start: December 1, 2009
• Primary Completion: May 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 16, 2013

Record last verified: 2013-07

Locations

SE (1)