Intramyocardial TransPlantation Of BonE MaRrow Stem Cells For ImprovEment Of Post-Infarct MyoCardial RegeneraTion In Addition To CABG Surgery: a controlled prospective, randomized, double blinded multicenter trial. (PERFECT)
- Conditions
- Patients with coronary artery disease scheduled for CABG surgery
- Registration Number
- DRKS00000213
- Lead Sponsor
- Miltenyi Biotec GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 82
Coronary artery disease after myocardial infarction with indication for CABG surgery.
Currently reduced global left ventricular ejection fraction (LVEF) assessed at site by cardiac magnetic resonance imaging (MRI) at rest (25% <= LVEF <= 50%).
Presence of a localized akinetic/hypokinetic/hypoperfused area of LV myocardium for defining the target area.
Informed consent of the patient.
18 years <= Age < 80 years.
Are not pregnant and do not plan to become pregnant during the study. Females with childbearing potential must provide a negative pregnancy test within 1-7 days before OP and must be using oral or injectable contraception (non childbearing potential is defined as post-menopausal for at least 1 year or surgical sterilization or hysterectomy at least 3 months before study start).
Emergency operation.
Presence of any moderate-severe valvular heart disease requiring concomitant valve replacement or reconstruction.
Medical History of recent resuscitation in combination with ventricular arrhythmia classified by LOWN >= class II.
Acute myocardial infarction within last 2 weeks.
Debilitating other disease: Degenerative neurologic disorders, psychiatric disease, terminal renal failure requiring dialysis, previous organ transplantation, active malignant neoplasia, or any other serious medical condition that, in the opinion of the Investigator is likely to alter the patient's course of recovery or the evaluation of the study medication's safety.
Impaired ability to comprehend the study information.
Absence of written informed consent.
Treatment with any investigational drug within the previous 30 days.
Apparent infection (c-reactive protein [CRP] >= 20 mg/L, fever >= 38.5°C).
Contraindication for MRI scan.
Immune compromise including active infection with Hepatitis B, C, HIV virus or seropositivity for Treponema pallidum.
Pregnant or breast feeding.
Childbearing potential with unreliable birth control methods
Have previously been enrolled in this study, respectively phase I and phase II.
Known hypersensitivity or sensitization against murine products and human-anti-mouse-antibody-titer >= 1:1000.
Contraindication to bone marrow aspiration.
Known hypersensitivity against iron dextran.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eft ventricular ejection fraction (LVEF) at 6 months postoperatively, measured by MRI at rest
- Secondary Outcome Measures
Name Time Method Change in LVEF at 6 months post-OP compared with preoperatively (screening) and early postoperatively (discharge) as assessed by MRI and echocardiography || Change in LV dimensions (left ventricular end systolic dimension [LVESD], left ventricular end diastolic dimension [LVEDD]) at 6 month post-OP compared with preoperatively (screening) and early postoperatively (discharge) as assessed by echocardiography. || Change in physical exercise capacity determined by 6 minute walk test at 6 months post-OP compared with preoperatively (screening) and early postoperatively (discharge). || Change in NYHA and CCS class at 6 months post-OP compared with preoperatively (screening) and early postoperatively (discharge). || MACE (cardiac death, myocardial infarction, secondary intervention/reoperation, ventricular arrhythmia). || QoL-score at 6 months post-OP compared with preoperatively (screening) and 3 months (telephone).