Efficacy and Safety Study of Genetically Targeted Enzyme Replacement Therapy for Advanced Heart Failure (CUPID)
19. srpna 2014 aktualizováno: Celladon Corporation
A Phase 1/2 Trial of Intracoronary Administration of MYDICAR® (AAV1/SERCA2a) in Subjects With Heart Failure in Two Stages (Open-Label, Sequential Dose-Escalation Cohorts and Randomized, Double-Blind, Placebo-Controlled, Parallel Cohorts)
The study is divided into 2 parts.
In the first part, the safety of the gene transfer agent MYDICAR® will be evaluated.
In the second part, the ability of MYDICAR® to improve heart function will be studied.
Přehled studie
Postavení
Dokončeno
Detailní popis
The American Heart Association (AHA) 2006 update on heart disease reported that 5 million Americans are believed to have symptomatic heart failure (HF), and 550,000 patients are newly diagnosed each year. The estimated direct and indirect cost of HF in the United States (U.S.) for 2006 will be ~$29.6 billion. Heart failure is a disabling chronic disease and the most frequent discharge diagnosis for hospitalization among older adults. Despite the significant resources expended on the treatment of this disease, outcomes remain poor. The five-year survival for individuals diagnosed with heart failure is less than 50%, and in end-stage heart failure, the one-year survival may be as low as 25% regardless of medical therapy.
Recent studies suggest that the failing heart is not refractory to treatment, as was previously believed. For example, the observation that a small percentage of subjects with left ventricular assist devices (LVADs) can be permanently weaned from their device strongly suggests that damaged hearts are capable of recovering lost function.
Clinical studies of MYDICAR® have not yet been conducted in humans. Celladon Corporation (Celladon) proposes to investigate gene transfer as a method to restore SERCA2a function in heart failure (HF) patients using a recombinant adeno-associated viral vector (AAV), which consists of an AAV serotype 1 capsid and contains the human SERCA2a complementary DNA (cDNA) flanked by Inverted Terminal Repeats (ITR) derived from AAV serotype 2 (AAV1/SERCA2a). MYDICAR® refers to AAV1/SERCA2a drug product intended for administration by percutaneous delivery.
Typ studie
Intervenční
Zápis (Aktuální)
51
Fáze
- Fáze 2
- Fáze 1
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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California
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San Diego, California, Spojené státy, 92123
- San Diego Cardiac Center
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San Diego, California, Spojené státy, 92103
- University of California at San Diego Medical Center
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Florida
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Gainesville, Florida, Spojené státy, 32608
- Shands Hospital at University of Florida
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Illinois
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Chicago, Illinois, Spojené státy, 60611
- Northwestern University
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Chicago, Illinois, Spojené státy, 60637
- University Of Chicago Medical Center
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Missouri
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Kansas City, Missouri, Spojené státy, 64111
- Mid America Heart Institute, Saint Luke's Hospital
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St. Louis, Missouri, Spojené státy, 63110
- St. Louis University Hospital
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New Jersey
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Newark, New Jersey, Spojené státy, 07101
- University of Medicine and Dentistry of New Jersey
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New York
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New York, New York, Spojené státy, 10029
- Mount Sinai Medical Center
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New York, New York, Spojené státy, 10032
- Columbia University Hospital
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North Carolina
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Winston-Salem, North Carolina, Spojené státy, 27157
- Wake Forest University
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Ohio
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Cincinnati, Ohio, Spojené státy, 45267
- University of Cincinnati
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Cleveland, Ohio, Spojené státy, 44109
- MetroHealth Medical Center
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Cleveland, Ohio, Spojené státy, 44195
- Cleveland Clinic Foundation
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Oregon
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Portland, Oregon, Spojené státy, 97239
- Oregon Health and Science University
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Pennsylvania
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Philadelphia, Pennsylvania, Spojené státy, 19104
- Hospital of the University of Pennsylvania
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Pittsburgh, Pennsylvania, Spojené státy, 15213
- University of Pittsburgh Medical Center, Presbyterian-Shadyside Hospital
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Tennessee
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Tullahoma, Tennessee, Spojené státy, 37388
- Tennessee Center for Clinical Trials & Harton Regional Medical Center
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Texas
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Dallas, Texas, Spojené státy, 75230
- Cardiopulmonary Research Science and Technology Institute, Medical City Dallas Hospital
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Houston, Texas, Spojené státy, 77030
- Methodist Hospital
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Utah
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Murray, Utah, Spojené státy, 84157
- Intermountain Medical Center
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Wisconsin
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Madison, Wisconsin, Spojené státy, 53792
- University of Wisconsin
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 75 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Chronic ischemic or non-ischemic cardiomyopathy. Subjects with ischemic cardiomyopathy must have at least one major coronary vessel with Thrombolysis in Myocardial Infarction (TIMI) grade 3 flow.
- Left ventricular ejection fraction (LVEF) ≤35%
- Diagnosis of New York Heart Association (NYHA) Class III/IV heart failure for a minimum of 3 months prior to screening
- Maximal oxygen consumption (VO2 max) ≤20 mL/kg/min within 90 days prior to enrollment
- An implantable cardioverter defibrillator (ICD) implanted a minimum of 30 days prior to enrollment
- Treatment with appropriate heart failure therapy as tolerated
- All women of childbearing potential must have a negative urine pregnancy test prior to administration of investigational product and agree to use adequate contraception. Men capable of fathering a child must agree to use barrier contraception or limit activity to post-menopausal, surgically sterilized, or a contraception-practicing partner, for 3 months after administration of investigational product.
- Ability to sign Informed Consent Form (ICF) and Release of Medical Information Form
Exclusion Criteria:
- Any intravenous therapy with positive inotropes, vasodilators, or diuretics within 30 days prior to enrollment
- Restrictive cardiomyopathy, obstructive cardiomyopathy, pericardial disease, amyloidosis, infiltrative cardiomyopathy, uncorrected thyroid disease, or dyskinetic LV aneurysm
- Cardiac surgery, percutaneous coronary intervention, or valvuloplasty within 30 days prior to enrollment
- Clinically significant myocardial infarction (e.g., ST elevation MI [STEMI] or large non-STEMI) within 6 months prior to enrollment
- Prior heart transplantation, left ventricular reduction surgery (LVRS), cardiomyoplasty, passive restraint device (e.g., CorCap™ Cardiac Support Device), surgically implanted LVAD or cardiac shunt
- Likely to receive cardiac resynchronization therapy, cardiomyoplasty, LVRS, heart transplant, conventional revascularization procedure, or valvular repair within 6 months following enrollment
- Patients with prior coronary artery bypass graft(s) (CABG) will reviewed on a case-by-case basis
- No evidence of functional or viable myocardium
- Exercise capacity primarily limited by obesity, peripheral vascular disease, intrinsic pulmonary disease or orthopedic problems and not by underlying heart failure
- Known hypersensitivity to octafluoropropane (component of the intravenous echocardiography contrast agent, DEFINITY®) or other contrast dyes used for angiography; history of, or likely need for, high dose steroid pretreatment prior to contrast angiography
- A left ventricle that is difficult to image or high quality echocardiography is not obtainable at screening
- Significant left main or ostial right coronary lumenal stenosis in the opinion of the investigator
- Expected survival <1 year in the investigator's medical opinion
- Suspected or active viral, bacterial, fungal, or parasitic infection within 48 hours prior to enrollment
- Liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase) >2x Upper Limit of Normal (ULN) within 30 days prior to enrollment or known intrinsic liver disease (e.g., cirrhosis, chronic hepatitis B or hepatitis C virus infection)
- Current or likely need for hemodialysis within 12 months following enrollment
- Bleeding diathesis or thrombocytopenia defined as platelet count <50,000 platelets/μL
- Anemia defined as hemoglobin <10 g/dL
- Known AIDS or HIV-positive status, or a previous diagnosis of immunodeficiency with an absolute neutrophil count <1000 cells/mm3
- Previous participation in a study of gene transfer
- Presence of neutralizing anti-AAV1 antibodies at titer ≥1:2 within 3 months of screening
- Receiving investigational intervention or participating in another clinical study within 30 days or within 5 half-lives of the investigational drug administration prior to enrollment
- Pregnancy or lactation
- Recent history of psychiatric disease (including drug or alcohol abuse) that is likely to impair subject's ability to comply with protocol-mandated procedures, in the opinion of the investigator
- Other concurrent medical condition(s) that, while not explicitly excluded by the protocol, could jeopardize the safety of the patient or objectives of the study
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: MYDICAR Very Low Dose
Single dose of MYDICAR, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1.4x10e11 DNAase resistant particles administered by antegrade epicardial coronary artery infusion.
Used in MYDICAR Phase 1 (Open-label, Serial Dose-Escalation Study) only.
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MYDICAR administered by antegrade epicardial coronary artery infusion
Ostatní jména:
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Experimentální: MYDICAR Low Dose
Single dose of MYDICAR, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6x10e11 DNAase resistant particles administered by antegrade epicardial coronary artery infusion.
Used in MYDICAR Phase 1 (Open-label, Serial Dose-Escalation Study) and MYDICAR Phase 2 (Placebo-controlled, Randomized Study)
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MYDICAR administered by antegrade epicardial coronary artery infusion
Ostatní jména:
MYDICAR administered by antegrade epicardial coronary artery infusion
Ostatní jména:
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Experimentální: MYDICAR Mid Dose
Single dose of MYDICAR, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3x10e12 DNAase resistant particles administered by antegrade epicardial coronary artery infusion.
Used in MYDICAR Phase 1 (Open-label, Serial Dose-Escalation Study) and MYDICAR Phase 2 (Placebo-controlled, Randomized Study).
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MYDICAR administered by antegrade epicardial coronary artery infusion
Ostatní jména:
MYDICAR administered by antegrade epicardial coronary artery infusion
Ostatní jména:
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Experimentální: MYDICAR High Dose
Single dose of MYDICAR, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1x10e13 DNAase resistant particles administered by antegrade epicardial coronary artery infusion.
Used in MYDICAR Phase 1 (Open-label, Serial Dose-Escalation Study) and MYDICAR Phase 2 (Placebo-controlled, Randomized Study).
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MYDICAR administered by antegrade epicardial coronary artery infusion
Ostatní jména:
MYDICAR administered by antegrade epicardial coronary artery infusion
Ostatní jména:
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Komparátor placeba: Placebo infusion
A single dose of placebo (Sodium Chloride Injection, USP) administered by antegrade epicardial coronary artery infusion.
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Saline; epicardial coronary artery infusion
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Phase 2: Incidence of Treatment-emergent Adverse Events (TEAE) at 12 Months
Časové okno: 12 months
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Includes all adverse events that occurred from the time of first infusion of the investigational product or placebo to the 12-month visit.
The category of "TEAEs related to the investigational product (IP)" includes TEAEs considered by the investigator to be possibly, probably, or definitely related to the IP.
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12 months
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Phase 2: Length of Cardiovascular-related Hospitalizations at 6 Months
Časové okno: 6 months
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Mean number of days in the hospital for cardiovascular-related complications.
All hospitalizations were evaluated and classified by the blinded Clinical Endpoints Committee.
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6 months
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Phase 2: Change in Symptomatic Efficacy Domains From Baseline to Month 6: New York Heart Association (NYHA) Class and Minnesota Living With Heart Failure Questionnaire (MLWHFQ) Score
Časové okno: Baseline to 6 months
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NYHA classification is a symptomatic assessment in which the investigator evaluates subjects on a scale ranging from Class I (subjects with no limitation of activities, no symptoms from ordinary activities) to Class IV (subjects who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest). The MLWHFQ is a patient-reported quality of life (QoL) measure in which patients assess the impact of their heart condition on activities in the past month using a Likert scale ranging from 0 (no effect) to 5 (very much effect). Higher scores thus indicate a lower QoL. The maximum (worst) score is 105 and the minimum (best) score is 0. For both measures, changes from baseline with positive values indicate a worsening in symptoms and changes from baseline with negative values indicate an improvement in symptoms. |
Baseline to 6 months
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Phase 2: Change in 6-minute Walk Test (6MWT) From Baseline to Month 6
Časové okno: Baseline to 6 months
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The 6MWT measures the distance walked in meters during a 6-minute test.
Higher values indicate a better functional status.
Changes from baseline with negative values indicate a worsening in function and changes from baseline with positive values indicate an improvement in function.
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Baseline to 6 months
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Phase 2: Change in Peak Maximum Oxygen Consumption (VO2) From Baseline to Month 6
Časové okno: Baseline to 6 months
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Peak VO2 is a measure of maximal oxygen consumption during cardiopulmonary exercise testing; this study used the modified Naughton treadmill protocol.
Higher values indicate a better functional status.
Changes from baseline with negative values indicate a worsening in function and changes from baseline with positive values indicate an improvement in function.
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Baseline to 6 months
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Phase 2: Change in Absolute Levels of N-terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) From Baseline to Month 6
Časové okno: Baseline to 6 months
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NT-proBNP is a biomarker for heart failure.
Increased levels of this biomarker are associated with increased mortality and cardiovascular hospitalization in patients with heart failure.
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Baseline to 6 months
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Phase 2: Change in Percentage of Blood Ejected From the Left Ventricle (LV) (i.e., Left Ventricular Ejection Fraction [LVEF]) From Baseline to Month 6
Časové okno: Baseline to 6 months
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Contrast echocardiography was used to determine LVEF.
Increases in LVEF are associated with reduced mortality.
Changes from baseline with positive values indicate an improvement in heart function and changes from baseline with negative values indicate a worsening of heart function.
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Baseline to 6 months
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Phase 2: Change in Absolute Left Ventricular End Systolic Volume (LVESV) Frm Baseline to Month 6
Časové okno: Baseline to 6 months
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Contrast echocardiography was used to determine LVESV.
Decreases in LVESV are associated with reduced mortality.
Changes from baseline with positive values indicate a worsening in heart function and changes from baseline with negative values indicate an improvement in symptoms.
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Baseline to 6 months
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Phase 2: Length of Cardiovascular-related Hospitalizations at 12 Months
Časové okno: 12 months
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Mean number of days in the hospital for cardiovascular-related complications.
All hospitalizations were evaluated and classified by the blinded Clinical Endpoints Committee.
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12 months
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Phase 2: Change in Symptomatic Efficacy Domains From Baseline to Month 12: New York Heart Association (NYHA) Class and Minnesota Living With Heart Failure Questionnaire (MLWHFQ) Score
Časové okno: Baseline to 12 months
|
NYHA classification is a symptomatic assessment in which the investigator evaluates subjects on a scale ranging from Class I (subjects with no limitation of activities, no symptoms from ordinary activities) to Class IV (subjects who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest). The MLWHFQ is a patient-reported quality of life (QoL) measure in which patients assess the impact of their heart condition on activities in the past month using a Likert scale ranging from 0 (no effect) to 5 (very much effect). Higher scores thus indicate a lower QoL. The maximum (worst) score is 105 and the minimum (best) score is 0. For both measures, changes from baseline with positive values indicate a worsening in symptoms and changes from baseline with negative values indicate an improvement in symptoms. |
Baseline to 12 months
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Phase 2: Change in 6-minute Walk Test (6MWT) From Baseline to Month 12
Časové okno: Baseline to 12 months
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The 6MWT measures the distance walked in meters during a 6-minute test.
Higher values indicate a better functional status.
Changes from baseline with negative values indicate a worsening in function and changes from baseline with positive values indicate an improvement in function.
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Baseline to 12 months
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Phase 2: Change in Peak Maximum Oxygen Consumption (VO2) From Baseline to Month 12
Časové okno: Baseline to 12 months
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Peak VO2 is a measure of maximal oxygen consumption during cardiopulmonary exercise testing; this study used the modified Naughton treadmill protocol.
Higher values indicate a better functional status.
Changes from baseline with negative values indicate a worsening in function and changes from baseline with positive values indicate an improvement in function.
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Baseline to 12 months
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Phase 2: Change in Absolute Levels of N-terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) From Baseline to Month 12
Časové okno: Baseline to 12 months
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NT-proBNP is a biomarker for heart failure.
Increased levels of this biomarker are associated with increased mortality and cardiovascular hospitalization in patients with heart failure.
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Baseline to 12 months
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Phase 2: Change in Percentage of Blood Ejected From the Left Ventricle (LV) (i.e., Left Ventricular Ejection Fraction [LVEF]) From Baseline to Month 12
Časové okno: Baseline to 12 months
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Contrast echocardiography was used to determine LVEF.
Increases in LVEF are associated with reduced mortality.
Changes from baseline with positive values indicate an improvement in heart function and changes from baseline with negative values indicate a worsening of heart function.
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Baseline to 12 months
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Phase 2: Change in Absolute Left Ventricular End Systolic Volume (LVESV) From Baseline to Month 12
Časové okno: Baseline to 12 months
|
Contrast echocardiography was used to determine LVESV.
Decreases in LVESV are associated with reduced mortality.
Changes from baseline with positive values indicate a worsening in heart function and changes from baseline with negative values indicate an improvement in symptoms.
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Baseline to 12 months
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Phase 1 and Phase 2: All Subject Deaths Through 36 Months
Časové okno: 36 months
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All subject deaths that occurred during the 12-month study or the 24-month follow-up in subjects enrolled in either the Phase 1 or Phase 2 trial.
Events occurring after early termination from the trial are listed as occurring during long-term follow-up, but may have been within 12 months.
Specifically, two cardiovascular (CV) deaths in placebo subjects occurred following early study termination, but within 12 months of study initiation.
These deaths are therefore included under "Deaths within 12 months" but also listed as "Cardiovascular deaths in long-term follow-up."
Accordingly, the number of "Cardiovascular deaths in long-term follow-up" for the placebo group is greater than the number of "Deaths after 12 months," as 2 of the deaths occurred within 12 months but after early termination.
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36 months
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Randall Starling, MD, The Cleveland Clinic
- Vrchní vyšetřovatel: Thomas Cappola, MD, ScM, University of Pennsylvania
- Vrchní vyšetřovatel: Brian Jaski, MD, San Diego Cardiac Center
- Vrchní vyšetřovatel: Stephen Archer, MD, University of Chicago
- Vrchní vyšetřovatel: Donna Mancini, MD, Columbia University Hospital
- Studijní židle: Mariell Jessup, MD, University of Pennsylvania
- Vrchní vyšetřovatel: Daniel Pauly, MD, Shands Hospital, University of Florida at Gainesville
- Vrchní vyšetřovatel: Barry London, MD, University of Pittsburgh Medical Center
- Vrchní vyšetřovatel: Barry Greenberg, MD, University of California at San Diego Medical Center
- Vrchní vyšetřovatel: A. G. Kfoury, MD, Intermountain Medical Center
- Vrchní vyšetřovatel: Andrew Kao, MD, Mid America Heart Institute, Saint Luke's Hospital
- Vrchní vyšetřovatel: Paul J. Hauptman, MD, St. Louis University Hospital
- Vrchní vyšetřovatel: Jill Kalman, MD, Icahn School of Medicine at Mount Sinai
- Vrchní vyšetřovatel: Douglas W. Losordo, MD, Northwestern University
- Vrchní vyšetřovatel: Eric J. Eichhorn, MD, FACC, Cardiopulmonary Research Science and Technology Institutte, Medical City Dallas Hospital
- Vrchní vyšetřovatel: Stephanie H. Dunlap, DO, University of Cincinnati
- Vrchní vyšetřovatel: Vinay Thohan, MD, Wake Forest University
- Vrchní vyšetřovatel: Maryl R. Johnson, MD, University of Wisconsin, Madison
- Vrchní vyšetřovatel: Mark Dunlap, MD, MetroHealth Medical Center
- Vrchní vyšetřovatel: Joaquin E. Cigarroa, MD, Oregon Health and Science University
- Vrchní vyšetřovatel: Dinesh K. Gupta, MD, Tennessee Center for Clinical Trials, Harton Regional Medical Center
- Vrchní vyšetřovatel: Marc Klapholz, MD, University of Medicine and Dentistry of New Jersey
- Vrchní vyšetřovatel: Guillermo Torre, MD, The Methodist Hospital Research Institute
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- Horowitz JD, Rosenson RS, McMurray JJ, Marx N, Remme WJ. Clinical Trials Update AHA Congress 2010. Cardiovasc Drugs Ther. 2011 Feb;25(1):69-76. doi: 10.1007/s10557-011-6285-9.
- Hajjar RJ, Zsebo K, Deckelbaum L, Thompson C, Rudy J, Yaroshinsky A, Ly H, Kawase Y, Wagner K, Borow K, Jaski B, London B, Greenberg B, Pauly DF, Patten R, Starling R, Mancini D, Jessup M. Design of a phase 1/2 trial of intracoronary administration of AAV1/SERCA2a in patients with heart failure. J Card Fail. 2008 Jun;14(5):355-67. doi: 10.1016/j.cardfail.2008.02.005. Epub 2008 May 27.
- Jaski BE, Jessup ML, Mancini DM, Cappola TP, Pauly DF, Greenberg B, Borow K, Dittrich H, Zsebo KM, Hajjar RJ; Calcium Up-Regulation by Percutaneous Administration of Gene Therapy In Cardiac Disease (CUPID) Trial Investigators. Calcium upregulation by percutaneous administration of gene therapy in cardiac disease (CUPID Trial), a first-in-human phase 1/2 clinical trial. J Card Fail. 2009 Apr;15(3):171-81. doi: 10.1016/j.cardfail.2009.01.013.
- Jessup M, Greenberg B, Mancini D, Cappola T, Pauly DF, Jaski B, Yaroshinsky A, Zsebo KM, Dittrich H, Hajjar RJ; Calcium Upregulation by Percutaneous Administration of Gene Therapy in Cardiac Disease (CUPID) Investigators. Calcium Upregulation by Percutaneous Administration of Gene Therapy in Cardiac Disease (CUPID): a phase 2 trial of intracoronary gene therapy of sarcoplasmic reticulum Ca2+-ATPase in patients with advanced heart failure. Circulation. 2011 Jul 19;124(3):304-13. doi: 10.1161/CIRCULATIONAHA.111.022889. Epub 2011 Jun 27.
- Zsebo K, Yaroshinsky A, Rudy JJ, Wagner K, Greenberg B, Jessup M, Hajjar RJ. Long-term effects of AAV1/SERCA2a gene transfer in patients with severe heart failure: analysis of recurrent cardiovascular events and mortality. Circ Res. 2014 Jan 3;114(1):101-8. doi: 10.1161/CIRCRESAHA.113.302421. Epub 2013 Sep 24.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. března 2007
Primární dokončení (Aktuální)
1. srpna 2010
Dokončení studie (Aktuální)
1. srpna 2012
Termíny zápisu do studia
První předloženo
30. března 2007
První předloženo, které splnilo kritéria kontroly kvality
30. března 2007
První zveřejněno (Odhad)
2. dubna 2007
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
20. srpna 2014
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
19. srpna 2014
Naposledy ověřeno
1. srpna 2014
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CELL-001
- CUPID Trial (Identifikátor registru: NCT00454818)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .