- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00507156
Postconditioning in the Treatment of Acute ST-segment Elevation Myocardial Infarction (POSTCON)
Postconditioning Used to Limit Final Infarct Size in Patients With Acute ST-segment Elevation Myocardial Infarction
Standard treatment of patients with acute ST-segment elevation myocardial infarction consist of acute re-opening of the occluded coronary artery (primary PCI). Despite successful treatment of the epicardial vessel reperfusion is sometimes inadequate leading to large final infarct sizes. This phenomenon is known as the reperfusion injury. Several animal studies have indicated that graded re-opening of the artery may limit tissue damage. Generally this is referred to as mechanical postconditioning.
The study investigates the effect on final infarct size evaluated by magnetic resonance scan of postconditioning of ST-segment elevation myocardial infarctions. Mechanical postconditioning is performed by means of several balloon inflations in the injured vessel following its acute re-opening.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
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-
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Copenhagen, Danmark, 2100
- Cardiac Catherization Lab., Heart Center, Rigshospitalet, University of Copenhagen
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients more than 18 years
- STEMI < 12 hours
- TIMI 0-1 in infarct related artery
Exclusion Criteria:
- Multivessel disease (stenoses in non-infarct related arteries >70%)
- Cardiogenic shock
- Left main occlusions
- Lesions that cannot be treated with stents
- Previous CABG
- Pregnancy
- Severe renal insufficiency
- Previous extensive Q-wave infarction
- LBBB
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Mek postcon
Re-opening of the infarcted coronary artery by several balloon inflations separated by reperfusion of the vessel.
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Mechanical postconditioning with 4 cycles 30/30 sek balloon inflations
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Aktiv komparator: Standard treatment
Standard treatment (primary PCI)
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Acute re-opening of the occluded coronary artery
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Final infarct size evaluated by MR
Tidsramme: 3 month
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3 month
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
MACE (death, re-infarction, TLR)
Tidsramme: 1, 15 month
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1, 15 month
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Stent thrombosis
Tidsramme: 15 month
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15 month
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Thomas Engstrom, D.Sci., PhD, Cheif Consultant
Publikationer og nyttige links
Generelle publikationer
- Lonborg J, Holmvang L, Kelbaek H, Vejlstrup N, Jorgensen E, Helqvist S, Saunamaki K, Clemmensen P, Treiman M, Jensen JS, Engstrom T. ST-Segment resolution and clinical outcome with ischemic postconditioning and comparison to magnetic resonance. Am Heart J. 2010 Dec;160(6):1085-91. doi: 10.1016/j.ahj.2010.09.026.
- Lonborg J, Kelbaek H, Vejlstrup N, Jorgensen E, Helqvist S, Saunamaki K, Clemmensen P, Holmvang L, Treiman M, Jensen JS, Engstrom T. Cardioprotective effects of ischemic postconditioning in patients treated with primary percutaneous coronary intervention, evaluated by magnetic resonance. Circ Cardiovasc Interv. 2010 Feb 1;3(1):34-41. doi: 10.1161/CIRCINTERVENTIONS.109.905521. Epub 2010 Jan 26.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- KF 01 326257
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med ST-segment Myocardial Infarction
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Inha University HospitalAfsluttetST Segment Elevation Myokardieinfarkt | Ikke-ST-segment elevation myokardieinfarktKorea, Republikken
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RenJi HospitalAfsluttetST Segment Elevation Myokardieinfarkt
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Dong-A UniversityAfsluttetST-segment elevation myokardieinfarktKorea, Republikken
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Azienda Ospedaliera San Camillo ForlaniniUkendtST Segment Elevation MyokardieinfarktItalien
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Jinan Central HospitalUkendtST-segment elevation myokardieinfarktKina
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Rigshospitalet, DenmarkRekrutteringST Segment Elevation MyokardieinfarktDanmark
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RenJi HospitalUkendt
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RenJi HospitalUkendtST Segment Elevation MyokardieinfarktKina
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UOSD Emodinamica Diagnostica e InterventisticaUkendtST Segment Elevation MyokardieinfarktItalien
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Peking University First HospitalPhilips Electronics Nederland B.V. acting through Philips CTO organizationAfsluttetUstabil angina | ST Segment Elevation Myokardieinfarkt | Ikke-ST-segment elevation myokardieinfarktKina
Kliniske forsøg med Mechanical postconditioning
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Hepatopancreatobiliary Surgery Institute of Gansu...Afsluttet
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National Heart, Lung, and Blood Institute (NHLBI)AfsluttetHjertesygdomme | Hjerte-kar-sygdomme | Hjertesvigt, kongestivForenede Stater
-
Abbott Medical DevicesAktiv, ikke rekrutterende
-
Microvention-Terumo, Inc.RekrutteringSlag | Akut iskæmisk slagtilfælde | Iskæmisk | KarokklusionForenede Stater
-
Angiodynamics, Inc.AfsluttetLungeemboli | Akut lungeemboliForenede Stater
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University of Southern DenmarkOdense University Hospital; University of Salford; Sygehus Lillebaelt; Region... og andre samarbejdspartnereAfsluttetCerebral PareseDanmark
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Jason WilkenJohns Hopkins University; Mayo Clinic; Minneapolis Veterans Affairs Medical... og andre samarbejdspartnereIkke rekrutterer endnu