Coronary Artery DiseasePhase 4VSEL-CADNCT01633359
The Association Between Very Small Embryonic-like Stem Cells and the Prognosis of Coronary Artery Disease Patients
A Phase 4 study testing Intensive statin and Routine statin in people with Coronary Artery Disease, run by Ji Huang at 1 site in China.
Trial summary
Hypothesis: Peripheral blood Very Small Embryonic-like Stem Cells (VSELs) are different in coronary artery disease (CAD) patients from those without CAD, which might account for the benefits of Atorvastatin in CAD patients. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Intensive statin and Routine statin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Jul 2012to May 2013
- Phase
- Phase 4
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- CAD patients receiving coronary angiography (CAG) as positive subjects, 100 as control who are negative for CAG.
Who cannot join
- Infectious diseases, immunologically mediated disease, serious liver diseases, serious kidney diseases, malignant tumor, thrombocytopenia, pregnancy, occluded peripheral arterial diseases, bleeding or blood transfusion in the latest 2 months
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029
Ji Huang, MD, 86-10-64456535, salyherry@163.com
Ji Huang, MD
About this study
Official title: The Randomly Controlled Clinical Trial of the Association Between Very Small Embryonic-like Stem Cells and the Prognosis of Coronary Artery Disease Patients
Hypothesis: Peripheral blood Very Small Embryonic-like Stem Cells (VSELs) are different in coronary artery disease (CAD) patients from those without CAD, which might account for the benefits of Atorvastatin in CAD patients.
Read the detailed description
- Hypothesis: The VSELs might be mobilized in the situation of cardiac ischemia in CAD patients. In addition, the benefits derived from Atorvastatin administration in CAD patients may be related to VSELs via sCD40L-SDF1/CXCR4 signal pathway.
- The number and function of peripheral blood VSELs in CAD patients compared with the controls.
- Included patients: including 200 CAD patients receiving coronary angiography (CAG) as positive subjects, 100 as control who are negative for CAG.
- The IRB approve and all subjects sign the informed consent.
- All subjects will receive the detection and analysis of the peripheral blood VSELs, including VSEL number, immigration capability after sCD40L administration.
- All subjects will receive the follow-up for 1 year, and the MACE (major adverse cardiovascular events) are recorded including angina, repeat myocardial infarction, repeat revascularization, major organ dysfunction, and death.
- the association between VSELs and MACE in CAD patients will be statistically analyzed.
- Atorvastatin administration improves the prognosis of CAD patients through exerting impacts on VSELs
- Included patients: including 200 CAD patients receiving coronary angiography as positive subjects, 100 as control who are negative for coronary angiography.
- The IRB approve and all subjects sign the informed consent.
- Fifty CAD subjects will receive intensive Atorvastatin administration and 50 CAD patients receiving the routine Atorvastatin administration as controls.
- All subject will receive the follow-up for 1 year, and peripheral blood VSELs, SDF-1/CXCR4 are tested, and the MACE (major adverse cardiovascular events) are recorded including angina, repeat myocardial infarction, repeat revascularization, major organ dysfunction, and death.
- the Intensive Atorvastatin protocol indicates that 80mg Atorvastatin will be administrated before CAG, and then are followed with 20mg Atorvastatin during the entire study period.
- the Routine Atorvastatin protocol indicates that 20mg Atorvastatin daily during the entire study period.
- Conditions
- Coronary Artery Disease
- Being tested
- Intensive statin, Routine statin
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive statinDrug
Also called Intensive Atorvastatin
the Intensive Atorvastatin protocol indicates that once 80mg Atorvastatin will be administrated before CAG, and then will be followed with 20mg Atorvastatin daily during the entire study period.
Routine statinDrug
Also called Routine Atorvastatin.
the Routine Atorvastatin protocol indicates that 20mg Atorvastatin daily during the entire study period.
| Study group | Role | What they receive |
|---|---|---|
| Intensive statin | Experimental | 1. Fifty CAD subjects will receive intensive Atorvastatin administration and 50 CAD patients receiving the routine Atorvastatin administration as controls.
2. All subjects will receive the follow-up for 1 year, and peripheral blood VSELs, SDF-1/CXCR4 are tested, and the MACE (major adverse cardiovascular events) are recorded including angina, repeat myocardial infarction, repeat revascularization, major organ dysfunction, and death.
3. the Intensive Atorvastatin protocol indicates that 80mg Atorvastatin will be administrated before CAG, and then are followed with 20mg Atorvastatin during the entire study period. Receives: Drug: Intensive statin |
| Routine statin | Experimental | 1. Fifty CAD subjects will receive intensive Atorvastatin administration and 50 CAD patients receiving the routine Atorvastatin administration as controls.
2. All subjects will receive the follow-up for 1 year, and peripheral blood VSELs, SDF-1/CXCR4 are tested, and the MACE (major adverse cardiovascular events) are recorded including angina, repeat myocardial infarction, repeat revascularization, major organ dysfunction, and death.
3. the Routine Atorvastatin protocol indicates that 20mg Atorvastatin daily during the entire study period. Receives: Drug: Routine statin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of peripheral blood VSELs
All subject will receive the follow-up for 1 year, and peripheral blood VSELs are counted.
Measured: during 1 year after enrollment
Secondary outcomes (1)
MACE
All subject will receive the follow-up for 1 year, and the MACE (major adverse cardiovascular events) are recorded including angina, repeat myocardial infarction, repeat revascularization, major organ dysfunction, and death.
Measured: During 1 year in the study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2012 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ji Huang
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Sponsor-investigator, Ji Huang, Beijing Anzhen Hospital
- Investigators
- Hai-Yan Qian, MD,PhD, Study director, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633359
- Sponsor's protocol ID
- TRAVEL-CAD
- Acronym
- VSEL-CAD
- Status last verified
- Jul 2012
- First submitted
- 31 May 2012
- Last updated
- 6 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wojakowski W, Tendera M, Kucia M, Zuba-Surma E, Paczkowska E, Ciosek J, Halasa M, Krol M, Kazmierski M, Buszman P, Ochala A, Ratajczak J, Machalinski B, Ratajczak MZ. Mobilization of bone marrow-derived Oct-4+ SSEA-4+ very small embryonic-like stem cells in patients with acute myocardial infarction. J Am Coll Cardiol. 2009 Jan 6;53(1):1-9. doi: 10.1016/j.jacc.2008.09.029.
PubMed 19118716
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Randomly Controlled Clinical Trial of the Association Between Very Small Embryonic-like Stem Cells and the Prognosis of Coronary Artery Disease Patients
- ClinicalTrials.gov ID
- NCT01633359
- Acronym / sponsor ID
- VSEL-CAD / TRAVEL-CAD
- Conditions
- Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ji HuangUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- Jul 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 4 Jul 2012 (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.
Hypothesis: Peripheral blood Very Small Embryonic-like Stem Cells (VSELs) are different in coronary artery disease (CAD) patients from those without CAD, which might account for the benefits of Atorvastatin in CAD patients.
Detailed description
- Hypothesis: The VSELs might be mobilized in the situation of cardiac ischemia in CAD patients. In addition, the benefits derived from Atorvastatin administration in CAD patients may be related to VSELs via sCD40L-SDF1/CXCR4 signal pathway.
- The number and function of peripheral blood VSELs in CAD patients compared with the controls.
- Included patients: including 200 CAD patients receiving coronary angiography (CAG) as positive subjects, 100 as control who are negative for CAG.
- The IRB approve and all subjects sign the informed consent.
- All subjects will receive the detection and analysis of the peripheral blood VSELs, including VSEL number, immigration capability after sCD40L administration.
- All subjects will receive the follow-up for 1 year, and the MACE (major adverse cardiovascular events) are recorded including angina, repeat myocardial infarction, repeat revascularization, major organ dysfunction, and death.
- the association between VSELs and MACE in CAD patients will be statistically analyzed.
- Atorvastatin administration improves the prognosis of CAD patients through exerting impacts on VSELs
- Included patients: including 200 CAD patients receiving coronary angiography as positive subjects, 100 as control who are negative for coronary angiography.
- The IRB approve and all subjects sign the informed consent.
- Fifty CAD subjects will receive intensive Atorvastatin administration and 50 CAD patients receiving the routine Atorvastatin administration as controls.
- All subject will receive the follow-up for 1 year, and peripheral blood VSELs, SDF-1/CXCR4 are tested, and the MACE (major adverse cardiovascular events) are recorded including angina, repeat myocardial infarction, repeat revascularization, major organ dysfunction, and death.
- the Intensive Atorvastatin protocol indicates that 80mg Atorvastatin will be administrated before CAG, and then are followed with 20mg Atorvastatin during the entire study period.
- the Routine Atorvastatin protocol indicates that 20mg Atorvastatin daily during the entire study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive statin | Experimental | Drug: Intensive statin1. Fifty CAD subjects will receive intensive Atorvastatin administration and 50 CAD patients receiving the routine Atorvastatin administration as controls. 2. All subjects will receive the follow-up for 1 year, and peripheral blood VSELs, SDF-1/CXCR4 are tested, and the MACE (major adverse cardiovascular events) are recorded including angina, repeat myocardial infarction, repeat revascularization, major organ dysfunction, and death. 3. the Intensive Atorvastatin protocol indicates that 80mg Atorvastatin will be administrated before CAG, and then are followed with 20mg Atorvastatin during the entire study period. |
| Routine statin | Experimental | Drug: Routine statin1. Fifty CAD subjects will receive intensive Atorvastatin administration and 50 CAD patients receiving the routine Atorvastatin administration as controls. 2. All subjects will receive the follow-up for 1 year, and peripheral blood VSELs, SDF-1/CXCR4 are tested, and the MACE (major adverse cardiovascular events) are recorded including angina, repeat myocardial infarction, repeat revascularization, major organ dysfunction, and death. 3. the Routine Atorvastatin protocol indicates that 20mg Atorvastatin daily during the entire study period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- CAD patients receiving coronary angiography (CAG) as positive subjects, 100 as control who are negative for CAG.
Key exclusion criteria (1 listed)
- Infectious diseases, immunologically mediated disease, serious liver diseases, serious kidney diseases, malignant tumor, thrombocytopenia, pregnancy, occluded peripheral arterial diseases, bleeding or blood transfusion in the latest 2 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive statinAlso: Intensive Atorvastatinthe Intensive Atorvastatin protocol indicates that once 80mg Atorvastatin will be administrated before CAG, and then will be followed with 20mg Atorvastatin daily during the entire study period. | Drug | Intensive statin |
| Routine statinAlso: Routine Atorvastatin.the Routine Atorvastatin protocol indicates that 20mg Atorvastatin daily during the entire study period. | Drug | Routine statin |
Primary outcome
Number of peripheral blood VSELs
Time frame: during 1 year after enrollment
All subject will receive the follow-up for 1 year, and peripheral blood VSELs are counted.
1 secondary outcome
MACE
Time frame: During 1 year in the study period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2012.
- Background: PubMed 19118716Wojakowski W, Tendera M, Kucia M, Zuba-Surma E, Paczkowska E, Ciosek J, Halasa M, Krol M, Kazmierski M, Buszman P, Ochala A, Ratajczak J, Machalinski B, Ratajczak MZ. Mobilization of bone marrow-derived Oct-4+ SSEA-4+ very small embryonic-like stem cells in patients with acute myocardial infarction. J Am Coll Cardiol. 2009 Jan 6;53(1):1-9. doi: 10.1016/j.jacc.2008.09.029.
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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.
Hai-Yan Qian, MD,PhD study director
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intensive statin and Routine statin in people with Coronary Artery Disease, run by Ji Huang 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 1 inclusion and 1 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 6 Jul 2012. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Ji Huang, MD (86-10-64456535, salyherry@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of peripheral blood VSELs (time frame: during 1 year after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01633359, which also lists 1 linked publication.
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 6 Jul 2012.