Effect of the Use and Timing of Bone Marrow Mononuclear Cell Delivery on Left Ventricular Function After Acute Myocardial Infarction The TIME Randomized Trial

Title

Effect of the Use and Timing of Bone Marrow Mononuclear Cell Delivery on Left Ventricular Function After Acute Myocardial Infarction The TIME Randomized Trial

Creator

Traverse J H; Henry T D; Pepine C J; Willerson J T; Zhao D X M; Ellis S G; Forder J R; Anderson R D; Hatzopoulos A K; Penn M S; Perin E C; Chambers J; Baran K W; Raveendran G; Lambert C; Lerman A; Simon D I; Vaughan D E; Lai D J; Gee A P; Taylor D A; Cogle C R; Thomas J D; Olson R E; Bowman S; Francescon J; Geither C; Handberg E; Kappenman C; Westbrook L; Piller L B; Simpson L M; Baraniuk S; Loghin C; Aguilar D; Richman S; Zierold C; Spoon D B; Bettencourt J; Sayre S L; Vojvodic R W; Skarlatos S I; Gordon D J; Ebert R F; Kwak M; Moye L A; Simari R D; Cctrn

Publisher

Jama-Journal of the American Medical Association

Date

2012
2012-12

Description

Context While the delivery of cell therapy after ST-segment elevation myocardial infarction (STEMI) has been evaluated in previous clinical trials, the influence of the timing of cell delivery on the effect on left ventricular function has not been analyzed. Objectives To determine the effect of intracoronary autologous bone marrow mononuclear cell (BMC) delivery after STEMI on recovery of global and regional left ventricular function and whether timing of BMC delivery (3 days vs 7 days after reperfusion) influences this effect. Design, Setting, and Patients A randomized, 2 x 2 factorial, double-blind, placebo-controlled trial, Timing In Myocardial infarction Evaluation (TIME) enrolled 120 patients with left ventricular dysfunction (left ventricular ejection fraction [LVEF] <= 45%) after successful primary percutaneous coronary intervention (PCI) of anterior STEMI between July 17, 2008, and November 15, 2011, as part of the Cardiovascular Cell Therapy Research Network sponsored by the National Heart, Lung, and Blood Institute. Interventions Intracoronary infusion of 150 x 10(6) BMCs or placebo (randomized 2: 1) within 12 hours of aspiration and cell processing administered at day 3 or day 7 (randomized 1: 1) after treatment with PCI. Main Outcome Measures The primary end points were change in global (LVEF) and regional (wall motion) left ventricular function in infarct and border zones at 6 months measured by cardiac magnetic resonance imaging and change in left ventricular function as affected by timing of treatment on day 3 vs day 7. The secondary end points included major adverse cardiovascular events as well as changes in left ventricular volumes and infarct size. Results The mean (SD) patient age was 56.9 (10.9) years and 87.5% of participants were male. At 6 months, there was no significant increase in LVEF for the BMC group (45.2% [95% CI, 42.8% to 47.6%] to 48.3% [95% CI, 45.3% to 51.3%) vs the placebo group (44.5% [95% CI, 41.0% to 48.0%] to 47.8% [95% CI, 43.4% to 52.2%]) (P=.96). There was no significant treatment effect on regional left ventricular function observed in either infarct or border zones. There were no significant differences in change in global left ventricular function for patients treated at day 3 (-0.9% [95% CI, -6.6% to 4.9%], P=.76) or day 7 (1.1% [95% CI, -4.7% to 6.9%], P=.70). The timing of treatment had no significant effect on regional left ventricular function recovery. Major adverse events were rare among all treatment groups. Conclusion Among patients with STEMI treated with primary PCI, the administration of intracoronary BMCs at either 3 days or 7 days after the event had no significant effect on recovery of global or regional left ventricular function compared with placebo.

Subject

cardiosphere-derived cells; double-blind; General & Internal Medicine; intracoronary infusion; ischemic-heart-disease; progenitor cells; reduced neovascularization capacity; regeneration; repair; research network; stem-cells; therapy

Format

Journal Article

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Rights

Article information provided for research and reference use only. All rights are retained by the journal listed under publisher and/or the creator(s).

Pages

2380-2389

Issue

22

Volume

308

Citation

Traverse J H; Henry T D; Pepine C J; Willerson J T; Zhao D X M; Ellis S G; Forder J R; Anderson R D; Hatzopoulos A K; Penn M S; Perin E C; Chambers J; Baran K W; Raveendran G; Lambert C; Lerman A; Simon D I; Vaughan D E; Lai D J; Gee A P; Taylor D A; Cogle C R; Thomas J D; Olson R E; Bowman S; Francescon J; Geither C; Handberg E; Kappenman C; Westbrook L; Piller L B; Simpson L M; Baraniuk S; Loghin C; Aguilar D; Richman S; Zierold C; Spoon D B; Bettencourt J; Sayre S L; Vojvodic R W; Skarlatos S I; Gordon D J; Ebert R F; Kwak M; Moye L A; Simari R D; Cctrn, “Effect of the Use and Timing of Bone Marrow Mononuclear Cell Delivery on Left Ventricular Function After Acute Myocardial Infarction The TIME Randomized Trial,” NEOMED Bibliography Database, accessed January 18, 2022, https://neomed.omeka.net/items/show/7363.

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