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NCT06298513 Clinical Trial

Autonomic and Metabolic Response to Cardiac Rehabilitation After Acute MI

Acute Myocardial Infarction: Rehabilitation Phase Clinical Trial

— RIABILITOMICA  

Official title:
Autonomic and Metabolic Response to Cardiac Rehabilitation After Acute Myocardial Infarction

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06298513
Other study ID # 09C338
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 2, 2023
Est. completion date December 2025

Study information
Verified date March 2024
Source Istituto Auxologico Italiano
Contact Gianfranco Parati, MD
Phone 039 0261911
Email gianfranco.parati@unimib.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Ischemic heart disease remains the leading cause of death in the western world. The beneficial effects of cardiac rehabilitation on the evolution of ischemic heart disease are known, but the effects of rehabilitation on the metabolic processes of the patients are so far poorly understood. Metabolomics is the qualitative/quantitative analysis of the body's metabolic responses to pathophysiological stimuli or genetic alterations. Metabolic changes caused by physical activity have been demonstrated in obese and diabetic patients and in athletes. Aim of the study is to evaluate whether cardiac rehabilitation after a first myocardial infarction induces changes in the metabolic state of patients, and whether these changes may be related with changes in the usual risk factors (i.e. glyco-lipidic profile, natriuretic peptides, homocysteine).

Recruitment information / eligibility
Status Recruiting
Enrollment 25
Est. completion date December 2025
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender Male
Age group 25 Years to 75 Years
Eligibility Inclusion Criteria: - recent first acute myocardial infarction Exclusion Criteria: - severe diabetes

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Cardiac rehabilitation
Six weeks of cardiac rehabilitation with physical training

Locations
Country Name City State
Italy Istituto Auxologico Italiano Milan

Sponsors (1)
Lead Sponsor Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in purine after rehabilitation The concentration of purine will be calculated after rehabilitation, and compared to its baseline concentration by a paired T test analysis. Baseline and after 6 weeks of rehabilitation
Primary Changes in histidine after rehabilitation The concentration of purine will be calculated after rehabilitation, and compared to its baseline concentration by a paired T test analysis Baseline and after 6 weeks of rehabilitation
Primary Changes in galactose after rehabilitation The concentration of galactose will be calculated after rehabilitation, and compared to its baseline concentration by a paired T test analysis. Baseline and after 6 weeks of rehabilitation
See also
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Completed NCT02402582 - Effect of Family-Centered Empowerment Model N/A
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