Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Federico II University |
---|---|
Information provided by: | Federico II University |
ClinicalTrials.gov Identifier: | NCT00755131 |
This purpose of this study is to examine the relationship between HMGB-1 and postinfarction predictors of outcome such as cardiopulmonary and echocardiographic parameters before and after a 6-month exercise-based cardiac rehabilitation program.
Condition | Intervention |
---|---|
Acute Myocardial Infarction |
Other: Exercise-based Cardiac Rehabilitation |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Single Blind (Investigator), Parallel Assignment |
Official Title: | Effects of Cardiac Rehabilitation on High Mobility Group Box-1 Levels After Acute Myocardial Infarction |
Estimated Enrollment: | 60 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
Postinfarction patients undergo 6-month exercise-based Cardiac Rehabilitation Program
|
Other: Exercise-based Cardiac Rehabilitation
Trained patients attend the exercise training protocol for 6 months on hospital ambulatory-based regimen 3 times/week. Training sessions are supervised under continuous electrocardiography monitoring by a cardiologist, a physiotherapist and a graduate nurse. Each session is preceded by a 5-min warming-up and followed by a 5-min cooling-down. Exercise is performed for 30 min on a bicycle ergometer with the target of 60-70% of the peak oxygen consumption achieved at the initial symptom-limited cardiopulmonary exercise test. Exercise protocol is performed with a gradual increase in exercise workload until the achievement of the predefined target.
|
B: No Intervention |
Exercise-based Cardiac Rehabilitation after acute myocardial infarction (AMI) has beneficial effects on cardiovascular functional capacity, quality of life, risk factors modification, and morbidity and mortality. Mounting evidences suggest that inflammation plays a key role both on initiation and progression of atherosclerosis. Several markers of systemic inflammation appear to be active effectors in the pathophysiology of athero-thrombotic disease leading to the occurrence of AMI.
The high mobility group box 1 (HMGB-1) is a ubiquitous nuclear protein constitutively expressed in quiescent cells, and it has been implicated in several cellular functions, including determination of nucleosomal structure and stability, and binding of transcription factors to DNA sequences. HMGB-1 has been recently recognized as a critical mediator of inflammatory diseases. In fact, the passive release of this protein from necrotic or damaged cells represents an effective stimulus triggering the inflammatory response. Specifically, HMGB-1 binds to the receptor for advanced glycation end products (RAGE) and, in turns, it activates mitogen-activated protein-kinase (MAPK) and nuclear factor-κB (NF-κB).
This intracellular pathway leads to the production of several pro-inflammatory cytokines. Interestingly, increased levels of HMGB-1 have been observed in atherosclerotic lesions, suggesting that HMGB-1 might be involved in the pathophysiology of atherosclerosis.
This study was designed to investigate the relationship between HMGB-1 and strong postinfarction predictors of outcome such as cardiopulmonary and echocardiographic parameters before and after a 6-month exercise-based Cardiac Rehabilitation program.
Ages Eligible for Study: | 35 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Carlo Vigorito, M.D. | +39-81-746 ext 2639 | vigorito@unina.it |
Contact: Francesco Giallauria, M.D.; Ph.D. | +39-81-746 ext 3676 | giallauria@libero.it |
Italy | |
University of Naples "Federico II" | Recruiting |
Naples, Italy, 80131 | |
Contact: Carlo Vigorito, M.D. +39-81-746 ext 2639 vigorito@unina.it | |
Contact: Francesco Giallauria, M.D.; Ph.D. +39-81-746 ext 3676 giallauria@libero.it | |
Principal Investigator: Carlo Vigorito, M.D. |
Study Director: | Carlo Vigorito, M.D. | University of Naples "Federico II" |
Responsible Party: | Department of Clinical Medicine, Cardiovascular and Immunological Sciences ( Carlo Vigorito ) |
Study ID Numbers: | UNINA-15775 |
Study First Received: | September 17, 2008 |
Last Updated: | September 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00755131 |
Health Authority: | Italy: National Institute of Health |
Cardiac Rehabilitation High Mobility Group Box proteins Inflammatory markers Cardiopulmonary Functional Capacity Maximal Oxygen Consumption Echocardiography |
Left Ventricular Ejection Fraction Left Ventricular Chambers Dilation Left Ventricular Remodeling Left Atrium Remodeling Cardiac Remodeling Exercise Training |
Necrosis Heart Diseases Dilatation, Pathologic Myocardial Ischemia |
Vascular Diseases Ischemia Infarction Myocardial Infarction |
Pathologic Processes Cardiovascular Diseases |