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Effects of Intracoronary Progenitor Cell Therapy on Coronary Flow Reserve After Acute MI (REPAIR-ACS)

11. januar 2017 opdateret af: A. M. Zeiher, Johann Wolfgang Goethe University Hospital

Reinfusion of Enriched Progenitor Cells And Infarct Remodeling in Acute Coronary Syndrome: REPAIR - ACS

Coronary flow reserve is an important measure of the integrity of the coronary microcirculation. Moreover, impaired coronary flow reserve is a predictor of future cardiovascular events and poor prognosis in patients after acute myocardial infarction.

After acute myocardial infarction, coronary flow reserve remains significantly reduced. A previous randomized, double-blind Placebo-controlled trial (REPAIR-AMI) demonstrated complete normalization of coronary flow reserve after intracoronary application of autologous bone marrow-derived progenitor cells (but no effect in the placebo group) in patients with ST segment elevation myocardial infarction. The current study is planned to extend these findings to patients with Non-ST segment elevation myocardial infarction, since these patients have an equally reduced outcome.

Studieoversigt

Detaljeret beskrivelse

Improvement of neovascularization is a key mechanism of functional improvement of intracoronary application of progenitor cells after acute myocardial infarction. Since capillary density cannot be assessed histological in patients, measurement of coronary flow reserve is an exact means for estimating capillary density and assessing coronary microvascular function. With the help of an intracoronary Doppler Wire, coronary hemodynamics can be assessed at baseline and, for example, adenosin-induced maximal vasodilation. Calculation of the minimal vascular resistance indices allows to estimate the cross-sectional area, reflecting capillary density, and, in comparison with the time of the acute myocardial infarction, estimation of improved neovascularization at a later timepoint.

In order to improve neovascularization, which may then be associated with improved left ventricular contractility, we initiated the current trial.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

31

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

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

Studiesteder

      • Frankfurt, Tyskland, 60590
        • Med. Klinik III; Kardiologie
      • Leipzig, Tyskland, 04289
        • Universität Leipzig / Herzzentrum

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 til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

Patients with acute coronary syndrome (ST-depression in at least 2 leads > 0,1 mV), or T-wave inversion, with or without elevated myocardial biomarkers (Troponin T oder I), together with typical clinical presentation), treated as follows:

  • Acute percutaneous revascularization with stent implantation within 48 hours after symptom onset.
  • Successful acute PCI (residual stenosis < 30%, TIMI flow > 2).
  • Hemodynamic stability
  • Age 18 - 80 years
  • Written informed consent
  • Active contraception in women of childbearing age

Exclusion Criteria:

  • Patients with STEMI (ST elevation in 2 leads above 0,2 mV in lead V1, V2 oder V3 or above 0,1 mV in the other leads)
  • Necessity of additional PCI in non-infarct vessel at the time of study therapy (multi-vessel PCI in the acute event is possible)
  • Heart failure (LVEF ≤ 30 %).
  • Arteriovenous malformation or aneurysms
  • Active infection (C-reactive protein > 10 mg/dl), or fever, or diarrhoea within the last 4 weeks
  • Chronic inflammatory disease
  • HIV infection or active hepatitis
  • Neoplastic disease without documented complete remission within the last 5 years
  • Recent stroke within the last 3 months
  • Impaired kidney function (creatinin > 2,5 mg/dl) at the time of treatment
  • Significant liver disease (GOT > 2x upper normal value or spontaneous INR > 1,5.
  • Hematopoetic disease (anaemia with Hb< 8.5 mg/dl; thrombocytopenia < 100.000/µl; splenomegaly
  • Known allergies to Clopidogrel, Heparin or Abciximab
  • History of bleeding disorder
  • GI bleeding within the last 3 months
  • Major surgery or trauma within the last 2 months
  • Uncontrolled hypertension
  • Pregnancy
  • Mental disability
  • Previous progenitor cell therapy
  • Participation in a different clinical trial within the last 30 days

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 1
Intracoronary infusion of autologous bone marrow-derived progenitor cells after NSTEMI
intracoronary infusion of autologous bone marrow-derived progenitor cells isolated from 50 ml bone marrow aspirate
Placebo komparator: 2
Intracoronary infusion of Placebo after NSTEMI
intracoronary infusion of placebo medium

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Improvement of coronary flow reserve in the infarct vessel
Tidsramme: 4 months
4 months

Sekundære resultatmål

Resultatmål
Tidsramme
Improvement of relative coronary flow reserve
Tidsramme: 4 months
4 months
Improvement of global and regional left ventricular ejection fraction
Tidsramme: 4 months
4 months
Major adverse cardiac events (death, MI, rehospitalization for heart failure, revascularization)
Tidsramme: 4 months
4 months
Major adverse cardiac events (death, MI, rehospitalization for heart failure, revascularization)
Tidsramme: 12 months
12 months

Samarbejdspartnere og efterforskere

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

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Andreas M Zeiher, MD, Goethe University

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 2008

Primær færdiggørelse (Faktiske)

1. december 2014

Studieafslutning (Faktiske)

1. december 2015

Datoer for studieregistrering

Først indsendt

8. juli 2008

Først indsendt, der opfyldte QC-kriterier

8. juli 2008

Først opslået (Skøn)

9. juli 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

12. januar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. januar 2017

Sidst verificeret

1. januar 2017

Mere information

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 Koronararteriesygdom

3
Abonner