- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00765453
Bone Marrow Derived Adult Stem Cells for Acute Anterior Myocardial Infarction (REGEN-AMI)
27. februar 2020 opdateret af: Anthony Mathur, Barts & The London NHS Trust
Randomised Controlled Clinical Trial of the Use of Autologous Bone Marrow Derived Progenitor Cells to Salvage Myocardium in Patients With Acute Anterior Myocardial Infarction
Study hypothesis :
The purpose of this study is to determine whether Intracoronary infusion of autologous bone marrow derived progenitor cells to patients undergoing primary angioplasty for acute anterior myocardial infarction will lead to an improvement in cardiac function greater than that seen by placebo alone.
Aims
- To demonstrate that it is safe and feasible to deliver autologous bone marrow derived stem cells within hours of the primary angioplasty procedure
- To demonstrate the effects of autologous bone marrow derived stem cells on cardiac function using cardiac MRI (or cardiac CT), echocardiography and left ventriculography.
- To demonstrate the effect of autologous bone marrow derived stem cells in addition to standard care leads to improvement in cardiac function compared to patients saline(placebo) and standard care.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
100
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Copenhagen, Danmark
- Rigshopitalet, Unversity of Copenhagen
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London, Det Forenede Kongerige
- The Heart Hosptial, UCLH Foundation Trust
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London, Det Forenede Kongerige
- The Royal Free Hospital, Royal Free London Foundation Trust
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London
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Bethnal Green, London, Det Forenede Kongerige, E2 9JX
- London Chest Hospital, Barts and The London NHS Trust
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Lausanne, Schweiz
- Centre Hospitalier Universitaire Vaudois
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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 presenting to the Heart Attack Centre with acute anterior myocardial infarction (ST elevation in at least 2 contiguous anterior leads ≥ 0.2 mV) and treated with acute PCI with stent implantation within 24 hours after symptom onset
- Acute PCI / stent implantation has been successful (residual stenosis visually < 30% and TIMI flow ≥ 2).
- At the time of inclusion patient no longer requires i.v. catecholamines or mechanical hemodynamic support (aortic balloon pump)
- Significant regional wall motion abnormality in LV angiogram at the time of acute PCI in the LAD territory
- Age 18 - 80 Years (primary angioplasty confers an adverse prognosis in those over the age of 80 years)
- Written informed consent in the recruiting centres native language
Exclusion Criteria:
- Regional wall motion abnormality outside the area involved in the index acute myocardial infarction
- Need to revascularise additional vessels, outside the infarct artery as a planned procedure (these vessels can be treated at baseline)
- Arteriovenous malformations or aneurysms
- Active infection, or fever or diarrhoea within last 4 weeks
- Chronic inflammatory disease
- Known HIV infection or active hepatitis
- Neoplastic disease without documented remission within the past 5 years
- Cerebrovascular insult within 3 months
- Impaired renal function (creatinine > 200mmol) at the time of cell therapy
- Significant liver disease (GOT > 2x upper limit) or spontaneous INR > 1,5)
- Anemia (hemoglobin < 8.5 mg/dl)
- Platelet count < 100.000/µl
- Hypersplenism
- Known allergy or intolerance to clopidogrel, heparin or abciximab
- History of bleeding disorder
- Gastrointestinal bleeding within 3 months
- Major surgical procedure or trauma within 2 months
- Uncontrolled hypertension
- Pregnancy
- Mental retardation leading to inability to obtain informed consent
- Previously performed stem / progenitor cell therapy
- Participation in another 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: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Placebo komparator: Placebo
Placebo infusion
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Placebo infusion
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Eksperimentel: Intracoronary
Patients will be randomised in a 1:1 ratio to receive intracoronary injections of bone marrow derived stem/progenitor cells or placebo infusion through a percutaneous route
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Over-the-wire balloon catheter delivers infusion into coronary vessel using a stop-flow technique
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Longitudinal change in left ventricular function (ejection fraction)
Tidsramme: 1 year
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1 year
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Longitudinal change in left ventricular function (ejection fraction), change in left ventricular end systolic volume, and change in infarct size
Tidsramme: 3 months
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3 months
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Longitudinal change in left ventricular function as measured by LV angiography
Tidsramme: 6 months
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6 months
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Longitudinal change in left ventricular function assessed by echocardiography.
Tidsramme: 6 months
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6 months
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Change in left ventricular end systolic volume and change in infarct size.
Tidsramme: 12 months
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12 months
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Longitudinal change in left ventricular function assessed by echocardiography.
Tidsramme: 12 months
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12 months
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MACE
Tidsramme: 12 months
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12 months
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Change in Quality of life
Tidsramme: 6 and 12 months
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6 and 12 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Anthony Mathur, FRCP FESC Ph, Barts and the London NHS Trust
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
- Choudry F, Hamshere S, Saunders N, Veerapen J, Bavnbek K, Knight C, Pellerin D, Locca D, Westwood M, Rakhit R, Crake T, Kastrup J, Parmar M, Agrawal S, Jones D, Martin J, Mathur A. A randomized double-blind control study of early intra-coronary autologous bone marrow cell infusion in acute myocardial infarction: the REGENERATE-AMI clinical trialdagger. Eur Heart J. 2016 Jan 14;37(3):256-63. doi: 10.1093/eurheartj/ehv493. Epub 2015 Sep 23.
- Hamshere S, Choudhury T, Jones DA, Locca D, Mills P, Rothman M, Knight C, Parmar M, Agrawal S, Martin J, Mathur A. A randomised double-blind control study of early intracoronary autologous bone marrow cell infusion in acute myocardial infarction (REGENERATE-AMI). BMJ Open. 2014 Feb 18;4(2):e004258. doi: 10.1136/bmjopen-2013-004258.
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. marts 2008
Primær færdiggørelse (Faktiske)
1. marts 2014
Studieafslutning (Faktiske)
1. marts 2018
Datoer for studieregistrering
Først indsendt
2. oktober 2008
Først indsendt, der opfyldte QC-kriterier
2. oktober 2008
Først opslået (Skøn)
3. oktober 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. marts 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. februar 2020
Sidst verificeret
1. februar 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 07/Q0603/76
- 2007-002-144
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 .
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