DRKS00000213
Active, not recruiting
Phase 3
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) - PERFECT
Miltenyi Biotec GmbH0 sites82 target enrollmentSeptember 28, 2009
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Patients with coronary artery disease scheduled for CABG surgery
- Sponsor
- Miltenyi Biotec GmbH
- Enrollment
- 82
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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).
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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