NCT00350766

Brief Summary

The purpose of this study is to determine cell therapy efficacy in patients with ST elevation acute myocardial infarction (STEMI)

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2006

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 11, 2006

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2014

Completed
Last Updated

March 30, 2017

Status Verified

March 1, 2017

Enrollment Period

7.6 years

First QC Date

July 10, 2006

Last Update Submit

March 29, 2017

Conditions

Acute Myocardial Infarction

Keywords

Myocardial InfarctionMyocardial IschemiaVentricular RemodelingBone Marrow Cell TransplantationStem cells

Outcome Measures

Primary Outcomes (1)

  • Global Left Ventricular Ejection Fraction change

    6 months

Secondary Outcomes (7)

  • Death

    30 days, 90 days, 6 months and 1 year

  • Acute myocardial infarction, stroke and hospital admission due to cardiovascular cause

    30 days, 90 days, 6 months and 1 year

  • Reintervention of the AMI related artery and of the non-related artery

    30 days, 90 days, 6 months and 1 year

  • Regional wall motion, wall thickening, and volume of late contrast enhancement

    Baseline and 6 months

  • Evolutive alterations of the coronarian anatomy, as well as the patency of the coronary stents

    6 months

  • +2 more secondary outcomes

Study Arms (2)

Treated Group

EXPERIMENTAL

Intracoronary injection in the infarcted-related artery of 100 million bone marrow mononuclear cells resuspended in a 10 ml solution of saline with autologous serum.

Procedure: Autologous Bone Marrow Mononuclear Cells (ABMMC) Transplantation

Control Group

PLACEBO COMPARATOR

Intracoronary injection in the infarcted-related artery of placebo solution consisting of a saline containing autologous blood serum.

Procedure: Autologous Bone Marrow Mononuclear Cells (ABMMC) Transplantation

Interventions

Autologous Bone Marrow Mononuclear Cells (ABMMC) TransplantationPROCEDURE

Catheter based stem cells delivery of 100 million cells resuspended in a 10 ml solution of saline with autologous serum. About 100 ml of Bone Marrow aspirate were harvested from iliac crest between the fifth and seventh day after myocardial infarction. ABMMC were isolated by density gradient centrifugation on Ficoll-PaqueTM plus (Amersham Biosciences) and manipulated under aseptic conditions for injection, after being filtered through 100 um nylon mesh to remove cell aggregates.

Also known as: Catheter based stem cell delivery
Control GroupTreated Group

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients will be eligible if presenting all characteristics described below:
  • ST segment elevation myocardial infarction in two or more contiguous leads, and according to the WHO definition, at least one of the following two:
  • i) Presence of chest pain. ii) Elevation of the myonecrosis markers.
  • Age between 30 and 80 years old.
  • Ejection fraction ≤50% on Echocardiogram (Simpson) and segmentary dysfunction of the infarction area, measured between the 3rd and 5th day post AMI.
  • Among patients submitted to thrombolytic therapy, the angioplasty of the related artery should be preferably done up to 24h after thrombolysis, with a maximum deadline of 72h after thrombolysis.

You may not qualify if:

  • Patients will be ineligible if presenting any of the characteristics described below:
  • AMI related artery presenting TIMI \< 3 at the moment f cell injection.
  • Left Main Coronary Artery Lesion of \>50% or multivessel coronariopathy (\>70% lesion in vessels with \>2,0mm diameter in left anterior descending, circumflex and right coronary territory) indicating the need for CABG or angioplasty with three or more stents implant.
  • Coronary anatomy, after thrombolytic reperfusion, presenting no need for angioplasty with stent implant.
  • Cardiac arrest or Killip IV AMI at admission with need of ventilatory support.
  • Cardiogenic shock persisting up to the third day after AMI (with need of Intra-aortic balloon pump or vasopressors).
  • AMI mechanical complications (ventricular septal defect, papillary muscle rupture, and left ventricular free wall rupture).
  • Significant valve disease, defined as aortic stenosis (mean systolic pressure gradient across the aortic valve \>50mmHg), mitral stenosis with a valvar area less than 1,5 cm,2 moderate to severe aortic and/or mitral regurgitation.
  • Chronic use of immunosuppressive agents.
  • \> 2,0 mg/dl creatinine or previous dialysis treatment.
  • Presence of fever on the past 48h before injection glaring active systemic infection according to ACCP/SCCM (American College of Chest Physicians/Society of Critical Care Medicine) sepsis definition.
  • Sustained ventricular tachycardia 48h after AMI.
  • Illicit drugs abuse or alcohol abuse (based on DSM IV).
  • Any co morbidity, with survival impact in two years.
  • Myocarditis
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PROCEP/Hospital Pró-Cardíaco

Rio de Janeiro, Rio de Janeiro, 22280-000, Brazil

Location

Related Publications (2)

  • Dohmann HF, Silva SA, Sousa AL, Braga AM, Branco RV, Haddad AF, Oliveira MA, Moreira RC, Tuche FA, Peixoto CM, Tura BR, Borojevic R, Ribeiro JP, Nicolau JC, Nobrega AC, Carvalho AC. Multicenter double blind trial of autologous bone marrow mononuclear cell transplantation through intracoronary injection post acute myocardium infarction - MiHeart/AMI study. Trials. 2008 Jul 3;9:41. doi: 10.1186/1745-6215-9-41.

    PMID: 18598362BACKGROUND

  • Tura BR, Martino HF, Gowdak LH, dos Santos RR, Dohmann HF, Krieger JE, Feitosa G, Vilas-Boas F, Oliveira SA, Silva SA, Bozza AZ, Borojevic R, de Carvalho AC. Multicenter randomized trial of cell therapy in cardiopathies - MiHeart Study. Trials. 2007 Jan 18;8:2. doi: 10.1186/1745-6215-8-2.

    PMID: 17233910BACKGROUND

MeSH Terms

Conditions

Myocardial InfarctionMyocardial IschemiaVentricular Remodeling

Interventions

Transplantation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisPathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Hans F Dohmann, MD

    PROCEP/Pró-Cardíaco Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Control group received injection of saline with 5% autologous serum without the suspension of mononuclear cells.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double Blind Randomized Controlled Trial
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

July 10, 2006

First Posted

July 11, 2006

Study Start

July 1, 2006

Primary Completion

January 21, 2014

Study Completion

July 14, 2014

Last Updated

March 30, 2017

Record last verified: 2017-03

Locations

BR(1)