Clinical trial NCT00691834: Safety and Efficacy on Cell-based Therapy in Patients With Recent Large Acute Myocardial Infarction
Official title: ReNEW: A Phase 2, Randomized, Placebo-Controlled, Double-Blinded Study of the Efficacy and Safety of Autologous Bone Marrow Mononuclear Cell Transfer for Myocardial Salvage in Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Acute Myocardial Infarction
Heart Failure
Keywords: Magnetic resonance Imaging
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Duke Clinical Research Institute
First posted: 2008-06-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test bone marrow mononuclear cells for patients with recent heart attack who are at high risk of experiencing heart failure. This study drug is made of you own cells. Studies similar to this one have suggested that the use of cell-based transfer after heart attack can improve the recuperation of the heart. The purpose of this study is to assess whether cell transfer can improve the healing of the heart after a heart attack.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age and no more than 80 years of age.
* Acute ST-segment elevation MI
* Symptoms suggestive of acute MI
* ≥ 2mm ST-segment elevation in 2 or more precordial leads or ≥ 1mm in or more limb leads or new left bundle branch block
* Time from symptom onset to enrollment \< 120 hours
* Left ventricular dysfunction by contrast ventriculography or echocardiography
* EF above 25 % and lower than 40%
* Focal wall motion akinesis or dyskinesis
* Clearly identifiable infarct artery
* Patent infarct artery (TIMI flow grade 2 or 3) of ≥ 2 mm in diameter following successful stent placement

Exclusion Criteria:

* Planned treatment with bypass surgery or prior CABG
* Multi-vessel PCI
* Prior myocardial infarction by history or presence of pathologic Q-waves
* Active cardiogenic shock: mechanical ventilation, IABP, or vasopressors/inotropes
* Successful reperfusion \< 3 hrs from symptom onset
* Prior MI or significant chronic heart failure
* Pacemaker/defibrillator
* Contraindication to MRI (metallic foreign body, claustrophobia, inability to lie flat)
* Significant hepatic dysfunction or renal insufficiency (estimated creatinine clearance\<25 and/or serum Cr \>2.5 mg/dl)
* Baseline hematocrit \< 30
* Pregnancy, or lactation/parturition within the past 30 days
* Active or planned treatment with chemotherapy
* Anticipated difficulty with 90-day follow-up
* Evidence of a serious, active infection in the opinion of the investigator including, but not limited to subjects who are HIV, hepatitis B or C positive
* Any known severe hematological disease, malignancy, systemic or life threatening disorder that would be incompatible with the trial
* Previous enrollment in this trial
* Participation in an investigational drug or device study within the past 30 days

Primary outcomes:
measure: Difference in the change of left ventricular ejection fraction between placebo-treated and cell-treated patients
timeFrame: baseline and 90 days
measure: Occurence of arrhythmia, heart failure and death
timeFrame: 1 year
Secondary outcomes:
measure: Improvement in regional left ventricular function
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
affiliation: Duke Clinical Research Institute
name: Christopher B Granger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke Clinical Research Institute
name: Marc E Jolicoeur, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: