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Diagnostics for the Reperfusion Injury Following MI

19. marts 2009 opdateret af: RWTH Aachen University

New Imaging and Diagnostic Techniques for the Assessment of Reperfusion Injury in Myocardial Infarction.

The primary purpose of this study is to correlate new cardiac imaging modalities (2D, 3D echocardiography, contrast echocardiography, strain analysis and cardiac MRI) to biochemical parameters as the L-arginine-nitric oxide pathway and inflammatory cascades to characterize the reperfusion injury following myocardial infarction and thus providing a basis for further diagnostic and therapeutic approaches.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

By reperfusion of ischemic myocardium further tissue damage occurs (ischemia / reperfusion injury). Various contributing mechanisms have been discussed in experimental studies, e.g. disturbances in coronary microcirculation and consecutive induction of inflammatory cascades involving formation of reactive oxygen species. The ischemia / reperfusion injury causes diastolic and regional as well as global systolic dysfunction. The time course of the reperfusion injury within the first hours after reperfusion and its effects on the global geometry of the left ventricle have not been investigated so far. In the present study a comprehensive morphological and functional characterisation of the ischemia / reperfusion injury in the acute phase is performed. New cardiac imaging modalities (2D, 3D echocardiography, contrast echocardiography, strain analysis and cardiac MRI)and biochemical parameters including the L-arginine-nitric oxide pathway and inflammatory cascades are applied. Hereby morphological and biochemical markers for the functional recovery of myocardial function should be identified.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

200

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyskland
    • NRW
      • Aachen, NRW, Tyskland, 52074
        • Department of Medicine, Division of Cardiology, Pulmonary Diseases and Vascular Medicine at the University Hospital, RWTH Aachen

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

  • patients with acute ST elevation myocardial infarction and consecutive percutaneous coronary intervention of the infarct-related artery (first myocardial infarction and recurrent myocardial infarction, as long as infarct-related artery is occluded for the first time)
  • written informed consent

or 30 patients with stable CAD (control group 1) or 30 healthy volunteers regarding cardiovascular diseases (control group 2)

Beskrivelse

Inclusion Criteria:

  • patients with acute ST elevation myocardial infarction and consecutive percutaneous coronary intervention of the infarct-related artery (first myocardial infarction and recurrent myocardial infarction, as long as infarct-related artery is occluded for the first time)
  • written informed consent

or 30 patients with stable CAD (control group 1) or 30 healthy volunteers regarding cardiovascular diseases (control group 2)

Exclusion Criteria:

  • minors
  • incompetent persons
  • pregnant and lactating
  • moderate to severe renal insufficiency defined by an GFR < 60 ml/kg/m2
  • missing written consent
  • other reasons complicating a clinical reevaluation and/or coronary angiography

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
1
- patients with acute ST elevation myocardial infarction and consecutive percutaneous coronary intervention of the infarct-related artery
Medicin: contrast echocardiography
directly after PCI, at 24 h after PCI, before discharge and at 6 months
Andre navne:
  • with luminity or sonovue
Procedure: 2D and 3D echocardiography
directly after PCI, at 24 h after PCI, before discharge and at 6 months
Procedure: cardiac MRI
before discharge and after 6 months
Procedure: blood sampling

routine lab work plus infarction and inflammation biomarkers

1: before PCI, after PCI, at 34 hours, at discharge, at 6 months 2 and 3: one blood sample in total before PCI in 2 and at any time in 3
2
- 30 patients with stable CAD (control group 1)
Procedure: blood sampling

routine lab work plus infarction and inflammation biomarkers

1: before PCI, after PCI, at 34 hours, at discharge, at 6 months 2 and 3: one blood sample in total before PCI in 2 and at any time in 3
3
- 30 healthy volunteers regarding cardiovascular diseases (control group 2)
Procedure: blood sampling

routine lab work plus infarction and inflammation biomarkers

1: before PCI, after PCI, at 34 hours, at discharge, at 6 months 2 and 3: one blood sample in total before PCI in 2 and at any time in 3

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

RWTH Aachen University

Efterforskere

  • Ledende efterforsker: Wolfgang Lepper, Department of Medicine, Division of Cardiology, Pulmonary Diseases and Vascular Medicine at the University Hospital, RWTH Aachen

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2007

Primær færdiggørelse (Faktiske)

1. marts 2009

Studieafslutning (Faktiske)

1. marts 2009

Datoer for studieregistrering

Først indsendt

12. september 2007

Først indsendt, der opfyldte QC-kriterier

12. september 2007

Først opslået (Skøn)

14. september 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. marts 2009

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. marts 2009

Sidst verificeret

1. marts 2009

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IZKF BIOMAT Aachen TVB 119

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 Reperfusionsskade

Kliniske forsøg med contrast echocardiography

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Betingelser

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Kosttilskud

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Placeringer

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