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- Klinische proef NCT00463853
Stem Cell Therapy as Adjunct to Revascularization (STAR)
Stem Cell Therapy as Adjunct to Revascularization: STAR
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Utah
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Salt Lake City, Utah, Verenigde Staten, 84148
- VA Salt Lake City Health Care System, Salt Lake City
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Veteran
- Age 18 or older
- Ability to give informed consent
- Have documented CAD and depressed LV function (EF <40%) that is felt to be appropriately treated with surgical revascularization by the VA Salt Lake City Health Care System Cardiothoracic Surgery team and in accordance with the published 2004 ACC/AHA Guideline Update for Coronary Artery Bypass Graft Surgery; specifically, in accordance with the described indication for CABG in patients with Poor LV Function (see below).
Class I
- CABG should be performed in patients with poor LV function who have significant left main coronary artery stenosis. (Level of Evidence: B)
CABG should be performed in patients with poor LV function who have left main equivalent:
significant (greater than or equal to 70%) stenosis of the proximal LAD and proximal left circumflex artery. (Level of Evidence: B)
- CABG should be performed in patients with poor LV function who have proximal LAD stenosis with 2- or 3-vessel disease. (Level of Evidence: B)
Class IIa
CABG may be performed in patients with poor LV function with significant viable noncontracting, revascularizable myocardium and without any of the above anatomic patterns. (Level of Evidence: B)
- NHYA/CCA Class I or higher
- Abnormal cardiac wall segment on preoperative data
- Acutely stable myocardium without evidence of cardiogenic shock or evolving myocardial infarction
Exclusion Criteria:
- EF 40%
- CAD not amenable to CABG
- ACC/AHA Poor LV Function Class III - CABG should not be performed in patients with poor LV function without evidence of intermittent ischemia and without evidence of significant revascularizable viable myocardium. (Level of Evidence: B) Evidence of intermittent ischemia is defined clinically by Cardiovascular Disease Classification (see chart above). Objectively, this can be demonstrated by various modalities that can demonstrate ischemic myocardium. Such modalities include SCA, Echo, CMRI, and radionucleotide imaging.
- Patients undergoing cardiac re-operation
- Patients with operable valvular disease
- Patients with preexisting malignant arrhythmia
- Patients with preexisting systemic malignancy
- Patients with a contraindication to MRI
- Presence of ongoing local or systemic infection
- Participation in another clinical trial
- Emergency operation
- Preoperative cardiogenic shock or evolving myocardial infarction
- ASA Class V or contraindication to general anesthesia
- Pregnancy
- Prisoner
- Active history of alcohol or substance abuse
- Active psychiatric history leading to potential for poor study participation and follow-up
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Arm 1
direct intramyocardial injection of cells as adjunct to CABG
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
The primary outcome measure will be safety as measured by the incidence of postoperative serious adverse events (SAE) and adverse events (AE).
Tijdsspanne: 1 year
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1 year
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Ejection fraction measured by CMRI
Tijdsspanne: at baseline, 3 & 6 months
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at baseline, 3 & 6 months
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Echo
Tijdsspanne: at baseline, intervention, 2 weeks, 1 month, 3 months, 6 months and 1 year
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at baseline, intervention, 2 weeks, 1 month, 3 months, 6 months and 1 year
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Myocardial perfusion measured by gadolinium CMRI
Tijdsspanne: at baseline, 3 & 6 months
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at baseline, 3 & 6 months
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Exercise tolerance testing
Tijdsspanne: at baseline, 1 month, 3 months, 6 months, and 1 year
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at baseline, 1 month, 3 months, 6 months, and 1 year
|
Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Studie stoel: G. Russell Reiss, MD, VA Salt Lake City Health Care System, Salt Lake City
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CLNB-017-04S
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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-
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-
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