NCT01307371

Brief Summary

The purpose of this study is to investigate the efficacy and mechanism of bone marrow mononuclear cells (BMMNC) transplantation for diabetic and non-diabetic patients with ST-segment elevation myocardial infarction (STEMI)who have undergone percutaneous coronary intervention (PCI).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 2, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

March 2, 2011

Status Verified

February 1, 2011

Enrollment Period

1 year

First QC Date

February 24, 2011

Last Update Submit

February 28, 2011

Conditions

Left Ventricular Function Systolic DysfunctionLeft Ventricular Function Diastolic DysfunctionDeathMyocardial Reperfusion Injury

Keywords

Bone Marrow Mononuclear cells;Diabetes;ST-segment Elevation Myocardial Infarction;Percutaneous Coronary Intervention;Left Ventricular Function

Outcome Measures

Primary Outcomes (1)

  • Number of patient death during the follow up period

    Number of patient death during the follow up period as a measure of safety

    4years

Secondary Outcomes (7)

  • Left ventricular ejection fraction

    4 years

  • Myocardial perfusion scores as evaluated by Single-photon emission computed tomography (SPECT)

    4 years

  • Infarct size as evaluated by Single-photon emission computed tomography (SPECT)

    4 years

  • Number of target vessel revascularization

    4 years

  • Angina class according to the canadian cardiovascular society (CCS) classification

    4 years

  • +2 more secondary outcomes

Study Arms (2)

Diabetes

Patients with diabetes.

non-diabetes

Patients without diabetes.

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients of STEMI with the culprit lesion of left anterior decending (LAD)coronary artery were enrolled in this study.

You may qualify if:

  • age between 25 and 60 years old
  • STEMI according to the WHO definition
  • PCI \<12 hours from the onset of symptoms
  • LAD disease with an open infarct related artery

You may not qualify if:

  • previous myocardial infarction (MI)
  • cardiomyopathy
  • atrial fibrillation or flutter
  • previous heart surgery
  • severe valvular heart disease
  • disease of the hematopoietic system
  • NYHA functional class IV heart failure at baseline
  • severe renal, lung and liver disease
  • cancer
  • intra-cardiac thrombus
  • bone marrow disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum, Plasma

MeSH Terms

Conditions

DeathMyocardial Reperfusion InjuryDiabetes MellitusST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsCardiomyopathiesHeart DiseasesCardiovascular DiseasesMyocardial IschemiaVascular DiseasesReperfusion InjuryPostoperative ComplicationsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesMyocardial InfarctionInfarctionIschemiaNecrosis

Study Officials

  • Feng Cao, MD, PhD

    Air Force Military Medical University, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 24, 2011

First Posted

March 2, 2011

Study Start

March 1, 2007

Primary Completion

March 1, 2008

Study Completion

December 1, 2011

Last Updated

March 2, 2011

Record last verified: 2011-02

Locations

CN(1)