Rationale and design of the 'F.I.R.E.' study: A multicenter, double-blind, randomized, placebo-controlled study to measure the effect of FX06 (a fibrin-derived peptide Bβ15-42) on ischemia-reperfusion injury in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention

Cardiology

Volumn 108, Issue 2, 2007, Pages 117-123

  Atar, Dan ^a   Huber, Kurt ^b   Rupprecht, Hans Jürgen ^c   Kopecky, Stephen L ^d   Schwitter, Jürg ^e   Theek, Carmen ^f   Brandl, Katherine ^g   Henning, Rainer ^g   Geudelin, Bernard ^g  

^a AKER UNIVERSITY HOSPITAL   (Norway)

^b Wilhelminen Spital ^*  (Austria)

^c Gesundheits und Pflegezentrum Russelsheim   (Germany)

^d MAYO CLINIC   (United States)

^e UNIVERSITY HOSPITAL ZURICH   (Switzerland)

^f IFE Europe GmbH   (Germany)

^g Fibrex Medical Research and Development GmbH   (Austria)

Author keywords

Acute myocardial infarction; FX06; Percutaneous coronary intervention; Reperfusion injury; ST elevation

Indexed keywords

FX06 PROTEIN; PROTEIN; UNCLASSIFIED DRUG;

ACUTE HEART INFARCTION; ADULT; ANALYTIC METHOD; ARTICLE; BRAIN INFARCTION SIZE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG TOLERABILITY; HEART DEATH; HEART FAILURE; HEART INFARCTION; HEART MUSCLE PERFUSION; HEART VENTRICLE ARRHYTHMIA; HOSPITALIZATION; HUMAN; ISCHEMIA; MAJOR CLINICAL STUDY; MULTICENTER STUDY; NUCLEAR MAGNETIC RESONANCE IMAGING; OUTCOME ASSESSMENT; PERCUTANEOUS CORONARY INTERVENTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REPERFUSION INJURY; REVASCULARIZATION; SCINTIGRAPHY; ST SEGMENT ELEVATION;

ANGIOPLASTY, TRANSLUMINAL, PERCUTANEOUS CORONARY; CLINICAL TRIALS DATA MONITORING COMMITTEES; CONFLICT OF INTEREST; DOUBLE-BLIND METHOD; FIBRIN FIBRINOGEN DEGRADATION PRODUCTS; HUMANS; MAGNETIC RESONANCE IMAGING; MYOCARDIAL INFARCTION; MYOCARDIAL REPERFUSION INJURY; PEPTIDE FRAGMENTS; RESEARCH DESIGN; STATISTICS; TOMOGRAPHY, EMISSION-COMPUTED, SINGLE-PHOTON;

EID: 34548085159     PISSN: 00086312     EISSN: None     Source Type: Journal    
DOI: 10.1159/000095982     Document Type: Article

References (34)

1. Silber S, Albertsson P, Aviles F, Camici PG, Colombo A, Hamm CW, Jorgensen E, Marco J, Nordrehaug J-E, Ruzyllo W, Urban P, Stone GW, Wijns W: Guidelines for percutaneous coronary interventions. The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Eur Heart J 2005;26:804-847.
2. Klein LW, Anderson HV, Brindis R, Shaw RE;on behalf of the ACC-NCDR: Predictors of outcome of primary PCI in ST elevation myocardial infarction in 6,521 consecutive cases during 2001: a report from the American College of Cardiology - National Cardiovascular Data Registry (abstract 1806). Circulation 2002;104:II-363.
3. Shernan SK: Perioperative myocardial ischemia reperfusion injury. Anesthesiol Clin North Am 2003;21:465-485.
4. Ferrans VJ: Morphological methods for evaluation of myocardial protection. Ann Thorac Surg 1975;20:11-20.
5. Das UN: Free radicals, cytokines and nitric oxide in cardiac failure and myocardial infarction. Mol Cell Biochem 2000;215:145-152.
6. Frangogiannis NG, Smith CW, Entman ML: The inflammatory response in myocardial infarction. Cardiovasc Res 2002;53:31-47.
7. Kakkar AK, Lefer DJ: Leukocyte and endothelial adhesion molecule studies in knockout mice. Curr Opin Pharmacol 2004;4:154-158.
8. Oyama J, Blais C Jr, Liu X, Pu M, Kobzik L, Kelly RA, Bourcier T: Reduced myocardial ischemia-reperfusion injury in toll-like receptor 4-deficient mice. Circulation 2004;109:784-789.
9. Dhalla NS, Elmoselhi AB, Hata T, Makino N: Status of myocardial antioxidants in ischemia-reperfusion injury. Cardiovasc Res 2000;47:446-456.
10. Goudev A, Georgiev D, Atar D, Kehayov I, Kyurkchie S: Cell adhesion molecules in cardiovascular pathology - a glance into the future? Heart Drug 2001;1:225-235.
11. Rupprecht HJ, vom Dahl J, Terres W, Seyfarth KM, Richardt G, Schultheibeta HP, Buerke M, Sheehan FH, Drexler H: Cardioprotective effects of the Na(+)/H(+) exchange inhibitor cariporide in patients with acute anterior myocardial infarction undergoing direct PTCA. Circulation 2000;101:2902-2908.
12. Zeymer U, Suryapranata H, Monassier JP, Opolski G, Davies J, Rasmanis G, Linssen G, Tebbe U, Schroder R, Tiemann R, Machnig T, Neuhaus KL; ESCAMI Investigators: The Na(+)/H(+) exchange inhibitor eniporide as an adjunct to early reperfusion therapy for acute myocardial infarction. Results of the evaluation of the safety and cardioprotective effects of eniporide in acute myocardial infarction (ESCAMI) trial. J Am Coll Cardiol 2001;38:1644-1650.
13. Kopecky SL, Aviles RJ, Bell MR, Lobl JK, Tipping D, Frommell G, Ramsey K, Holland AE, Midei M, Jain A, Kellett M, Gibbons RJ: A randomized, double-blinded, placebo-controlled, dose-ranging study measuring the effect of an adenosine agonist on infarct size reduction in patients undergoing primary percutaneous transluminal coronary angioplasty: the ADMIRE (AmP579 Delivery for Myocardial Infarction REduction) study. Am Heart J 2003;146:146-152.
14. Mahaffey KW, Puma JA, Barbagelata NA, DiCarli MF, Leesar MA, Browne KF, Eisenberg PR, Bolli R, Casas AC, Molina-Viamonte V, Orlandi C, Blevins R, Gibbons RJ, Califf RM, Granger CB: Adenosine as an adjunct to thrombolytic therapy for acute myocardial infarction: results of a multicenter, randomized, placebo-controlled trial: the Acute Myocardial Infarction STudy of ADenosine (AMISTAD) trial. J Am Coll Cardiol 1999;34:1711-1720.
15. Ross AM, Gibbons RJ, Stone GW, Kloner RA, Alexander RW;AMISTAD-II Investigators: A randomized, double-blinded, placebo-controlled multicenter trial of adenosine as an adjunct to reperfusion in the treatment of acute myocardial infarction (AMISTAD-II). J Am Coll Cardiol 2005;45:1775-1780.
16. Jespersen CM, Hansen JF: Effect of verapamil on reinfarction and cardiovascular events in patients with arterial hypertension included in the Danish Verapamil Infarction Trial II. The Danish Study Group on Verapamil in Myocardial Infarction. J Hum Hypertens 1994;8:85-88.
17. Moiseyev VS, Poder P, Andrejevs N, Ruda MY, Golikov AP, Lazebnik LB, Kobalava ZD, Lehtonen LA, Laine T, Nieminen MS, Lie KI; RUSSLAN Study Investigators: Safety and efficacy of a novel calcium sensitizer, levosimendan, in patients with left ventricular failure due to an acute myocardial infarction. A randomized, placebo-controlled, double-blind study (RUSSLAN). Eur Heart J 2002;23:1405-1406.
18. Petzelbauer P, Zacharowski PA, Miyazaki Y, Peter Wickenhauser FG, Castellino FJ, Gröger M, Wolff K, Zacharowski K: The fibrin-derived peptide Bβ15-42 protects the myocardium against ischemia-reperfusion injury. Nat Med 2005;11:298-304.
19. Gibbons RJ, Miller TD, Christian TF: Infarct size measured by single photon emission computed tomographic imaging with (99m)Tc-sestamibi: a measure of the efficacy of therapy in acute myocardial infarction. Circulation 2000;101:101-108.
20. Burns RJ, Gibbons RJ, Yi Q, Roberts RS, Miller TD, Schaer GL, Anderson JL, Yusuf S; CORE Study Investigators: The relationships of left ventricular ejection fraction, end-systolic volume index and infarct size to six-month mortality after hospital discharge following myocardial infarction treated by thrombolysis. J Am Coll Cardiol 2002;39:30-36.
21. Schömig A, Kastrati A, Dirschinger J, Mehilli J, Schriche U, Pache J, Martinoff S, Neumann F-J, Schwaiger M: Coronary stenting plus platelet glycoprotein IIb/IIIa blockade compared with tissue plasminogen activator in acute myocardial infarction. Stent versus Thrombolysis for Occluded Coronary Arteries in Patients with Acute Myocardial Infarction Study Investigators. N Engl J Med 2000;343:385-391.
22. Kastrati A, Mehilli J, Dirschinger J, Schricke U, Neverve J, Pache J, Martinoff S, Neumann FJ, Nekolla S, Blasini R, Seyfarth M, Schwaiger M, Schomig A; Stent versus Thrombolysis for Occluded Coronary Arteries in Patients with Acute Myocardial Infarction (STOPAMI-2) Study: Myocardial salvage after coronary stenting plus abciximab versus fibrinolysis plus abciximab in patients with acute myocardial infarction: a randomised trial. Lancet 2002;359:920-925.
23. Miller TD, Christian TF, Hopfenspirger MR, Hodge DO, Gersh BJ, Gibbons RJ: Infarct size after acute myocardial infarction measured by quantitative tomographic 99mTc sestamibi imaging predicts subsequent mortality. Circulation 1995;92:334-341.
24. Bauer P, Köhne K: Evaluation of experiments with adaptive interim analyses. Biometrics 1994;50:1029-1041.
25. Gibbons RJ, Christian TF, Hopfenspirger M, Hodge DO, Bailey KR: Myocardium at risk and infarct size after thrombolytic therapy for acute myocardial infarction: implications for the design of randomized trials of acute intervention. J Am Coll Cardiol 1994;24:616.
26. Sinusas AJ, Trautman KA, Bergin JD, Watson DD, Ruiz M, Smith WH, Beller GA: Quantification of area at risk during coronary occlusion and degree of myocardial salvage after reperfusion with technetium-99m methoxyisobutyl isonitrile. Circulation 1990;82:1424-1437.
27. Klein C, Nekolla SG, Bengel FM, Momose M, Sammer A, Haas F, Schnackenburg B, Delius W, Mudra H, Wolfram D, Schwaiger M: Assessment of myocardial viability with contrast-enhanced magnetic resonance imaging: comparison with positron emission tomography. Circulation 2002;105:162-167.
28. De Winter RJ, Fischer JC, de Jongh T, van Straalen JP, Bholasingh R, Sanders GT: Different time frames for the occurrence of elevated levels of cardiac troponin T and C-reactive protein in patients with acute myocardial infarction. Clin Chem Lab Med 2000;38:1151-1153.
29. Schoenhagen P: The emerging role of delayed contrast-enhanced magnetic resonance imaging in the peri-operative evaluation of patients undergoing coronary revascularisation. Eur Heart J 2004;25:1279-1280.
30. Abdel-Aty H, Friedrich MG, Schulz-Menger J: Myocardial infarction after coronary revascularization: role of cardiovascular magnetic resonance oedema imaging. Eur Heart J 2004;25:2172.
31. Ibrahim T, Nekolla SG, Hörnke M, Bülow HB, Dirschinger J, Schömig A, Schwaiger M: Quantitative measurement of infarct size by contrast-enhanced magnetic resonance imaging early after acute myocardial infarction comparison with single-photon emission tomography using Tc99m-sestamibi. J Am Coll Cardiol 2005;45:544-552.
32. Knuesel PR, Nanz D, Wyss C, Buechi M, Kaufmann PA, von Schulthess GK, Lüscher TF, Schwitter J: Characterization of dysfunctional myocardium by positron emission tomography and magnetic resonance. Relation to functional outcome after revascularization. Circulation 2003;108:1095-1100.
33. Wu E, Judd RM, Vargas JD, Klocke FJ, Bonow RO, Kim RJ: Visualisation of presence, location, and transmural extent of healed Q-wave and non-Q-wave myocardial infarction. Lancet 2001;357:21-28.
34. Kim RJ, Wu E, Rafael A, Chen EL, Parker MA, Simonetti O, Klocke FJ, Bonow RO, Judd RM: The use of contrast-enhanced magnetic resonance imaging to identify reversible myocardial dysfunction. N Engl J Med 2001;343:1445-1453.