Evidence map›Paper›PMID 22084195›Full record

Trial reportJAMA2011

Effect of intracoronary delivery of autologous bone marrow mononuclear cells 2 to 3 weeks following acute myocardial infarction on left ventricular function: the LateTIME randomized trial.

Jay H Traverse, Timothy D Henry, Stephen G Ellis, Carl J Pepine, James T Willerson, David X M Zhao, John R Forder, Barry J Byrne, Antonis K Hatzopoulos, Marc S Penn and 36 more

Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in JAMA, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00684060 (A Phase II, Randomized, Controlled, Double-Blind Pilot Trial Evaluating the Safety and Effect of Administration of Bone Marrow Mononuclear Cells Two to Three Weeks Following Acute Myocardial Infarction), which is not on this map. Cited by 187 papers, 20 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
187citing papers in PubMed, 20 pooled it
25.3field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00684060 phase2completednot on this map

A Phase II, Randomized, Controlled, Double-Blind Pilot Trial Evaluating the Safety and Effect of Administration of Bone Marrow Mononuclear Cells Two to Three Weeks Following Acute Myocardial Infarction

TypeinterventionalSponsorThe University of Texas Health Science Center, HoustonRan2008 to 2012Enrolled87ConditionsLeft Ventricular DysfunctionArmsAdult stem cells, Placebo
3 · Its place in the literature

Who cites it

187 citing papers in PubMed, 20 syntheses or guidelines pooled it, 403 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Pooled it
  11. Pooled it
  12. Pooled it
  13. Pooled it
  14. Stem cell treatment for acute myocardial infarction.The Cochrane database of systematic reviews · 2015
    Pooled it
  15. Pooled it
  16. Pooled it
  17. The effect of bone marrow mononuclear stem cell therapy on left ventricular function and myocardial perfusion.Journal of nuclear cardiology : official publication of the American Society of Nuclear Cardiology · 2014
    Pooled it
  18. Pooled it
  19. Pooled it
  20. Pooled it

127 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

46 authors at 1 institution in 1 country.

Jay H TraverseMinneapolis Heart Institute Foundation at Abbott Northwestern Hospital, Minneapolis, Minnesota, USA.
Timothy D Henry
Stephen G Ellis
Carl J Pepine
James T Willerson
David X M Zhao
John R Forder
Barry J Byrne
Antonis K Hatzopoulos
Marc S Penn
Emerson C Perin
Kenneth W Baran
Jeffrey Chambers
Charles Lambert
Ganesh Raveendran
Daniel I Simon
Douglas E Vaughan
Lara M Simpson
Adrian P Gee
Doris A Taylor
Christopher R Cogle
James D Thomas
Guilherme V Silva
Beth C Jorgenson
Rachel E Olson
Sherry Bowman
Judy Francescon
Carrie Geither
Eileen Handberg
Deirdre X Smith
Sarah Baraniuk
Linda B Piller
Catalin Loghin
David Aguilar
Sara Richman
Claudia Zierold
Judy Bettencourt
Shelly L Sayre
Rachel W Vojvodic
Sonia I Skarlatos
David J Gordon
Ray F Ebert
Minjung Kwak
Lemuel A Moyé
Robert D Simari
Cardiovascular Cell Therapy ResearchNetwork
University of Minnesota · US

Funding

Data Coordinating Center For The Cardiovascular Cell Therapy Research NetworkUM1HL087318 · NHLBI · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI DAVIS, BARRY R · 2012 to 2018
$29.8M
Cardiovascular Cell Therapy Research Network - Data Coordinating CenterU01HL087318 · NHLBI · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI MOYE, LEMUEL A. · 2007 to 2011
$17.6M
UFRCC for Cardiovascular Cell Therapy Research NetworkUM1HL087366 · NHLBI · UNIVERSITY OF FLORIDA · PI PEPINE, CARL J · 2012 to 2018
$4.7M
PROTECTIVE TREATMENT FOR CATHETERSR43HL037164 · NHLBI · DENVER BIOMATERIALS, INC. · PI NEWKIRK, JOHN B · 1987 to 1987
–
NHLBI NIH HHS 5 U01 HL087318-04NHLBI NIH HHS HHSN268201000007CNHLBI NIH HHS HHSN268201000008CNHLBI NIH HHS N01 HB037163NHLBI NIH HHS N01 HB037164NHLBI NIH HHS N01-HB-37163NHLBI NIH HHS N01-HB-37164NHLBI NIH HHS U01 HL087318NHLBI NIH HHS UM1 HL087318NHLBI NIH HHS UM1 HL087366
6 · The paper itself

Abstract

contextClinical trial results suggest that intracoronary delivery of autologous bone marrow mononuclear cells (BMCs) may improve left ventricular (LV) function when administered within the first week following myocardial infarction (MI). However, because a substantial number of patients may not present for early cell delivery, the efficacy of autologous BMC delivery 2 to 3 weeks post-MI warrants investigation.

objectiveTo determine if intracoronary delivery of autologous BMCs improves global and regional LV function when delivered 2 to 3 weeks following first MI. DESIGN, SETTING, AND PATIENTS: A randomized, double-blind, placebo-controlled trial (LateTIME) of the National Heart, Lung, and Blood Institute-sponsored Cardiovascular Cell Therapy Research Network of 87 patients with significant LV dysfunction (LV ejection fraction [LVEF] ≤45%) following successful primary percutaneous coronary intervention (PCI) between July 8, 2008, and February 28, 2011.

interventionsIntracoronary infusion of 150 × 10(6) autologous BMCs (total nucleated cells) or placebo (BMC:placebo, 2:1) was performed within 12 hours of bone marrow aspiration after local automated cell processing.

main outcome measuresChanges in global (LVEF) and regional (wall motion) LV function in the infarct and border zone between baseline and 6 months, measured by cardiac magnetic resonance imaging. Secondary end points included changes in LV volumes and infarct size.

resultsA total of 87 patients were randomized (mean [SD] age, 57 [11] years; 83% men). Harvesting, processing, and intracoronary delivery of BMCs in this setting was feasible. Change between baseline and 6 months in the BMC group vs placebo for mean LVEF (48.7% to 49.2% vs 45.3% to 48.8%; between-group mean difference, -3.00; 95% CI, -7.05 to 0.95), wall motion in the infarct zone (6.2 to 6.5 mm vs 4.9 to 5.9 mm; between-group mean difference, -0.70; 95% CI, -2.78 to 1.34), and wall motion in the border zone (16.0 to 16.6 mm vs 16.1 to 19.3 mm; between-group mean difference, -2.60; 95% CI, -6.03 to 0.77) were not statistically significant. No significant change in LV volumes and infarct volumes was observed; both groups decreased by a similar amount at 6 months vs baseline.

conclusionAmong patients with MI and LV dysfunction following reperfusion with PCI, intracoronary infusion of autologous BMCs vs intracoronary placebo infusion, 2 to 3 weeks after PCI, did not improve global or regional function at 6 months.

trial registrationclinicaltrials.gov Identifier: NCT00684060.

Indexed as

Ventricular Function, LeftAdultAgedAngioplasty, Balloon, CoronaryBone Marrow TransplantationDouble-Blind MethodFemaleHumansMaleMiddle AgedMyocardial InfarctionStroke VolumeTransplantation, AutologousTreatment OutcomeVentricular Dysfunction, Left

Identifiers

PMID22084195
PMCPMC3600981
OpenAlexW2143815163

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.