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
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
-
-
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
|
directly after PCI, at 24 h after PCI, before discharge and at 6 months
Andre navne:
directly after PCI, at 24 h after PCI, before discharge and at 6 months
before discharge and after 6 months
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)
|
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)
|
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
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.
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
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 .