Study on the Efficacy and Mechanism of Cardiac Rehabilitation for Stem Cell Mobilization and Heart Failure Improvement

NCT00154466 | Completed Results DMC

• 1 other identifier: 9261701248
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

One emerging concept is that some form of injury or inflammation is a prerequisite for the success of circulating-cell participation in differentiated tissue structure and function. Once reperfusion is achieved in acute myocardial infarction, an intense inflammatory cascade is unleashed. The architecture of the left ventricle rearranges, leading to ventricular remodeling. The "homing process"involves stem cell migration to the sites of injury or ischemia, which provides an environment that is favorable to growth and function. This microenvironment is a stimulus for homing and differentiation of stem cells of the appropriate lineage. It increases vascular permeability and expression of adhesion proteins like integrin, along with homing receptors that facilitate the attachment, which is mediated by cell-to-cell contact and chemoattractant release from local tissue injury.The migratory capacity of stem cells might be dependent on natural growth factors such as vascular endothelial growth factor (VEGF) , stromal cell-derived factor-1 (SDF-1)and stem cell factor (SCF).The expression of VEGF ,SDF-1 and SCF is highly up-regulated in hypoxic tissue, supporting the hypothesis that these factors may represent homing signals crucial to the recruitment of circulating progenitor cells to assist the endogenous repair mechanisms in the infarcted tissue. This study will examine whether cardiac rehabilitation increases the concentration of stem cell factors released into the bloodstream and if these factors are correlated with the improvement of heart function.

Conditions

Myocardial Infarction

Keywords

Myocardial infarction, stem cell, cardiac rehabilitation

Outcome Measures

Primary Outcomes (1)

• Myocardial Blood Flow at Baseline and 3-month Follow-up

  First-pass, contrast-enhanced myocardial perfusion images acquired for 80 heart beats in the left ventricle. Short-axis views were obtained after intravenous administration of gadodiamide. Perfusion studies were performed at rest and during the stress induced by a 4 min infusion of dipyridamole at a concentration of 0.14 mg/kg of body weight per minute.To determine absolute MBF values at rest and stress status, we adopted a model-independent deconvolution method proposed by Jerosch-Herold et al, a method that was previously validated in experimental animal studies by comparison with blood-flow measurements with radiolabelled microspheres.

  3 months

Secondary Outcomes (1)

• Angiogenic Cytokines at Baseline and 3-month Follow-up

  3 months

Study Arms (3)

cardiac rehabilitation

EXPERIMENTAL

Those in the training group participated in a 3-month rehabilitation training program at an exercise intensity of 55% to 70% of peak oxygen uptake (VO2.

Behavioral: cardiac rehabilitation

postinfarction patients

NO INTERVENTION

those in the nontraining group continued their usual lifestyle

healthy controls

PLACEBO COMPARATOR

Age-, weight-, and height-matched subjects without cardiovascular risk factors were selected as healthy controls.

Interventions

cardiac rehabilitation BEHAVIORAL

Those in the training group participated in a 3-month rehabilitation training program at an exercise intensity of 55% to 70% of peak oxygen uptake (VO2); those in the nontraining group continued their usual lifestyle.

Also known as: exercise training

cardiac rehabilitation

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (1)

• Lee BC, Hsu HC, Tseng WY, Su MY, Chen SY, Wu YW, Chien KL, Chen MF. Effect of cardiac rehabilitation on angiogenic cytokines in postinfarction patients. Heart. 2009 Jun;95(12):1012-8. doi: 10.1136/hrt.2008.153510. Epub 2009 Mar 19.

  PMID: 19304668 RESULT

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Cardiac Rehabilitation; Exercise

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

First, our trial is small size. Second, these results are applicable only for male patients less than 65 years old with ST-segment elevation MI after successful PCI. Third, the source of angiogenic cytokines cannot be elucidated.

Results Point of Contact

• Title: Dr. Bai-Chin Lee
• Organization: National Taiwan University Hospital

lebai@ntu.edu.tw

0223123456

Study Officials

• Bai-Chin Lee, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

• Ssu-Yuan Chen, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

• Wen-Yih Tseng, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

• Ming-Fong Chen, MD, PhD

  National Taiwan University Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 12, 2005
• Study Start: July 1, 2004
• Primary Completion: July 1, 2010
• Study Completion: December 1, 2011
• Last Updated: June 26, 2014
• Results First Posted: June 26, 2014

Record last verified: 2014-05

Locations

TW (1)