- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00351247
Postconditioning in Primary PCI and Direct Stenting
Clinical and MRI Evaluation of 2 Vs 4 Cycles of Postconditioning During Primary PCI With Direct Stenting
Studieoversikt
Detaljert beskrivelse
Sample size: 45 subjects
Site Locations: Sheba medical center
Patients: Patients presenting with an acute MI with onset of symptoms 6h, and planned to undergo primary PCI will be included. The target lesion should be located in the proximal or middle segment of a main native coronary artery, and should be suitable for percutaneous intervention.
Primary Objective: To determine the safety and efficacy of 2 vs 4 cycles of postconditioning method during primary PCI and direct stenting in acute MI, and to compared to primary PCI and direct stenting without the postconditioning.
Primary Endpoint:
- ST segment resolution.
- Segmental wall motion score, resolution of edema and wall thickness by echocardiography.
- Infarct size estimation by cardiac enzymes and cardiac MRI.
Secondary endpoints:
- Composite endpoint of Major Adverse Cardiac Events (MACE) at 30 and 90 days
Methods:
- ECG at baseline, immediately after procedure, 90 and 180 minutes after the procedure and 6-24 hours after intervention.
- Core laboratory angiography measurements of TIMI flow, corrected TIMI Frame count, myocardial blush score and left ventricular angiography.
- Myocardial enzymes measurements: every 4 hours in the first 24 hours and every 6 hours in the following 48 hours.
- Left ventricular ejection fraction and wall motion score determined by echocardiography.
- Cardiac MRI estimation of infarct size. • Clinical follow-up at 30 and 90 days post procedure.
Follow-up:
- Follow up at 30 days: Clinical.
- Clinical Follow up & Cardiac MRI at 90 days.
Studietype
Registrering
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Tel Hashomer, Israel
- Sheba Medical Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Patient is > 21 years of age and provides informed consent.
- Evidence of AMI as indicated by signs and symptoms. Diagnosis of ST-segment elevation AMI will be based on chest pain for >30 minutes and ST-segment elevation of >1mV in 2 limb lead or >2mV in 2 anterior leads contiguous leads on the 12-lead ECG.
- Eligible to undergo primary PCI.
- Symptom duration is < 6 hours prior to primary PCI.
- Angiographic: The target lesion in the infarct related artery (IRA) should be occluded (TIMI).
- Angiographic: The target lesion in the proximal or middle segment of a native major coronary artery (LAD, RCA or dominant CX).
- Angiographic: The target lesion should be suitable for PTCA or stenting.
- Angiographic: The IRA occlusion will be successfully opened by stenting with TIMI 2-3
Exclusion Criteria:
- Unwillingness to participate.
- Prior Acute MI
- Cardiac arrest or Killip score III-IV
- Women with known pregnancy.
- Active significant bleeding.
- Known allergy for aspirin, ticlopidine and clopidogrel, or heparin.
- Chronic renal failure with creatinine > 2 mg/dl
- Other medical illness associated with limited life expectancy or that may cause the patient to be non-compliant with the protocol.
- Current participation in other trials using investigational drugs or devices.
- Contraindications to MRI including: arrythmias, cardiac pacer, brain aneurysm clips, cochlear implants, nerve stimulator.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Hva måler studien?
Primære resultatmål
Resultatmål |
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ST segment resolution.
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Segmental wall motion score, resolution of edema and wall thickness by echocardiography.
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Infarct size estimation by cardiac enzymes and cardiac MRI.
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Sekundære resultatmål
Resultatmål |
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Composite endpoint of Major Adverse Cardiac Events (MACE) at 30 and 90 days
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Victor Guetta, MD, Sheba Medical Center
- Hovedetterforsker: Jonathan Leor, MD, Neufeld Cardiac Research Center
- Hovedetterforsker: Elad Maor, MD, Neufeld Cardiac Research Center
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Staat P, Rioufol G, Piot C, Cottin Y, Cung TT, L'Huillier I, Aupetit JF, Bonnefoy E, Finet G, Andre-Fouet X, Ovize M. Postconditioning the human heart. Circulation. 2005 Oct 4;112(14):2143-8. doi: 10.1161/CIRCULATIONAHA.105.558122. Epub 2005 Sep 26.
- Zhao ZQ, Corvera JS, Halkos ME, Kerendi F, Wang NP, Guyton RA, Vinten-Johansen J. Inhibition of myocardial injury by ischemic postconditioning during reperfusion: comparison with ischemic preconditioning. Am J Physiol Heart Circ Physiol. 2003 Aug;285(2):H579-88. doi: 10.1152/ajpheart.01064.2002. Erratum In: Am J Physiol Heart Circ Physiol. 2004 Jan;286(1):H477.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Studiet fullført
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SHEBA-06-4066-VG-CTIL
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