Left Ventricular Function Systolic DysfunctionNCT01307371
Cell Therapy in Diabetic Patients With ST-Segment Elevation Myocardial Infarction(STEMI)
An observational study of Left Ventricular Function Systolic Dysfunction and Left Ventricular Function Diastolic Dysfunction, run by Xijing Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Left Ventricular Function Systolic Dysfunction, Left Ventricular Function Diastolic Dysfunction, Death
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- Mar 2007to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients of STEMI with the culprit lesion of left anterior decending (LAD)coronary artery were enrolled in this study.
Who may be able to join
- 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
Who cannot join
- previous myocardial infarction (MI)
- cardiomyopathy
- atrial fibrillation or flutter
- previous heart surgery
- severe valvular heart disease
- disease of the hematopoietic system
Show all 11Show fewer
- NYHA functional class IV heart failure at baseline
- severe renal, lung and liver disease
- cancer
- intra-cardiac thrombus
- bone marrow disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital
Xi'an, Shaanxi, 710032
Dongdong Sun, MD, PhD, 86 29 84775183, wintersun3@gmail.com
About this study
Official title: Effects and Mechanism of Autologous Bone Marrow Mononuclear Cells (BMMNC)Transplantation in Diabetic Patients With ST-Segment Elevation Myocardial Infarction (STEMI) Who Have Undergone Percutaneous Coronary Intervention (PCI)
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).
Read the detailed description
Stem cells are capable of the important properties of self-renewal and differentiation plasticity. Human autologous bone marrow mononuclear cells (BMMNC) contain CD34+ haematopoietic and CD34- mesenchymal stem cells. Both of these cell types may contribute to heart muscle repair in acute myocardial infarction (AMI). In recent years, a variety of clinical trials have explored the hypothesis that BMMNC transplantation may enhance the recovery of left ventricular function after AMI. The use of BMMNC is clinically justified and ethically unquestionable because no severe side effects have been reported and immunosuppressive therapy is unnecessary. More over, our previous work showed that patients without diabetes may benefit more from BMMNC transplantation. Thus, the aim of the present study was 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 PCI.
- Conditions
- Left Ventricular Function Systolic Dysfunction, Left Ventricular Function Diastolic Dysfunction, Death, Myocardial Reperfusion Injury
- Keywords
- Bone Marrow Mononuclear cells;, Diabetes;, ST-segment Elevation Myocardial Infarction;, Percutaneous Coronary Intervention;, Left Ventricular Function
- Medical subject headings
- Death, Myocardial Reperfusion Injury, Diabetes Mellitus, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes | Patients with diabetes. | |
| non-diabetes | Patients without diabetes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient death during the follow up period
Number of patient death during the follow up period as a measure of safety
Measured: 4years
Secondary outcomes (7)
Left ventricular ejection fraction
Left ventricular ejection fraction as evaluated by echocardiography and SPECT
Measured: 4 years
Myocardial perfusion scores as evaluated by Single-photon emission computed tomography (SPECT)
Measured: 4 years
Infarct size as evaluated by Single-photon emission computed tomography (SPECT)
Measured: 4 years
Number of target vessel revascularization
Number of target vessel revascularization during the follow up period
Measured: 4 years
Angina class according to the canadian cardiovascular society (CCS) classification
Measured: 4 years
Scores on the Seattle angina questionnaire
Measured: 4 years
six-min walk distance (6MWD)
Quality of life as evaluated by 6-min walk distance
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2011 (estimated)
- Study startMar 2007
- Primary completionMar 2008
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular Function Systolic DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Feng Cao, MD, PhD, Principal investigator, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01307371
- Sponsor's protocol ID
- DIABETES-STEMI
- Status last verified
- Feb 2011
- First submitted
- 24 Feb 2011
- Last updated
- 2 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Mechanism of Autologous Bone Marrow Mononuclear Cells (BMMNC)Transplantation in Diabetic Patients With ST-Segment Elevation Myocardial Infarction (STEMI) Who Have Undergone Percutaneous Coronary Intervention (PCI)
- ClinicalTrials.gov ID
- NCT01307371
- Acronym / sponsor ID
- DIABETES-STEMI
- Conditions
- Left Ventricular Function Systolic Dysfunction, Left Ventricular Function Diastolic Dysfunction, Death, Myocardial Reperfusion Injury
- Keywords
- Bone Marrow Mononuclear cells;, Diabetes;, ST-segment Elevation Myocardial Infarction;, Percutaneous Coronary Intervention;, Left Ventricular Function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Dec 2011 (estimated)
- First posted
- 2 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Stem cells are capable of the important properties of self-renewal and differentiation plasticity. Human autologous bone marrow mononuclear cells (BMMNC) contain CD34+ haematopoietic and CD34- mesenchymal stem cells. Both of these cell types may contribute to heart muscle repair in acute myocardial infarction (AMI). In recent years, a variety of clinical trials have explored the hypothesis that BMMNC transplantation may enhance the recovery of left ventricular function after AMI. The use of BMMNC is clinically justified and ethically unquestionable because no severe side effects have been reported and immunosuppressive therapy is unnecessary. More over, our previous work showed that patients without diabetes may benefit more from BMMNC transplantation. Thus, the aim of the present study was 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 PCI.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes | – | –Patients with diabetes. |
| non-diabetes | – | –Patients without diabetes. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients of STEMI with the culprit lesion of left anterior decending (LAD)coronary artery were enrolled in this study.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- previous myocardial infarction (MI)
- cardiomyopathy
- atrial fibrillation or flutter
- previous heart surgery
- severe valvular heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patient death during the follow up period
Time frame: 4years
Number of patient death during the follow up period as a measure of safety
7 secondary outcomes
Left ventricular ejection fraction
Time frame: 4 years
Myocardial perfusion scores as evaluated by Single-photon emission computed tomography (SPECT)
Time frame: 4 years
Infarct size as evaluated by Single-photon emission computed tomography (SPECT)
Time frame: 4 years
Number of target vessel revascularization
Time frame: 4 years
Angina class according to the canadian cardiovascular society (CCS) classification
Time frame: 4 years
Scores on the Seattle angina questionnaire
Time frame: 4 years
six-min walk distance (6MWD)
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Feng Cao, MD, PhD principal investigator
Air Force Military Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Ventricular Function Systolic Dysfunction and Left Ventricular Function Diastolic Dysfunction, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patient death during the follow up period (time frame: 4years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2011.