- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06298513
Autonomic and Metabolic Response to Cardiac Rehabilitation After Acute MI (RIABILITOMICA)
August 19, 2025 updated by: Istituto Auxologico Italiano
Autonomic and Metabolic Response to Cardiac Rehabilitation After Acute Myocardial Infarction
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).
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
25
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Milan, Italy, 20149
- Istituto Auxologico Italiano
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
All consecutive patients meeting the eligibility criteria will be proposed to participate in the study
Description
Inclusion Criteria:
- recent first acute myocardial infarction
Exclusion Criteria:
- severe diabetes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patient after first acute myocardial infarction
|
Six weeks of cardiac rehabilitation with physical training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in purine after rehabilitation
Time Frame: Baseline and after 6 weeks of 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
|
|
Changes in histidine after rehabilitation
Time Frame: Baseline and after 6 weeks of 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
|
|
Changes in galactose after rehabilitation
Time Frame: Baseline and after 6 weeks of 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 2, 2023
Primary Completion (Actual)
June 12, 2024
Study Completion (Actual)
January 13, 2025
Study Registration Dates
First Submitted
March 1, 2024
First Submitted That Met QC Criteria
March 1, 2024
First Posted (Actual)
March 7, 2024
Study Record Updates
Last Update Posted (Actual)
August 21, 2025
Last Update Submitted That Met QC Criteria
August 19, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09C338
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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