The Association Between Very Small Embryonic-like Stem Cells and the Prognosis of Coronary Artery Disease Patients

NCT01633359 | Unknown Phase 4 DMC

• 1 other identifier: TRAVEL-CAD
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Number of peripheral blood VSELs

  All subject will receive the follow-up for 1 year, and peripheral blood VSELs are counted.

  during 1 year after enrollment

Secondary Outcomes (1)

• MACE

  During 1 year in the study period

Study Arms (2)

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.

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.

Drug: Routine statin

Interventions

Intensive statin DRUG

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.

Also known as: Intensive Atorvastatin

Intensive statin

Routine statin DRUG

the Routine Atorvastatin protocol indicates that 20mg Atorvastatin daily during the entire study period.

Also known as: Routine Atorvastatin.

Routine statin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CAD patients receiving coronary angiography (CAG) as positive subjects, 100 as control who are negative for CAG.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ji Huang: lead
• National Natural Science Foundation of China: collaborator

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

Location

Related Publications (1)

• 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.

  PMID: 19118716 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Hai-Yan Qian, MD,PhD

  Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

  STUDY DIRECTOR

Central Study Contacts

Ji Huang, MD

CONTACT

86-10-64456535; salyherry@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician of Cardiology

Study Record Dates

• First Submitted: May 31, 2012
• First Posted: July 4, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: May 1, 2013
• Last Updated: July 6, 2012

Record last verified: 2012-07

Locations

CN (1)