Acute Myocardial Infarction: Rehabilitation PhaseRIABILITOMICANCT06298513
Autonomic and Metabolic Response to Cardiac Rehabilitation After Acute MI
An observational study of Acute Myocardial Infarction: Rehabilitation Phase, run by Istituto Auxologico Italiano at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 25 to 75 years, men only
- Conditions the study is for
- Acute Myocardial Infarction: Rehabilitation Phase
- What is being tested?
- Cardiac rehabilitation
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 2 May 2023to 13 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients meeting the eligibility criteria will be proposed to participate in the study
Who may be able to join
- recent first acute myocardial infarction
Who cannot join
- severe diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Being tested
- Cardiac rehabilitation
- Keywords
- myocardial infarction, cardiac rehabilitation, metabolomic, autonomic nervous ststem
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac rehabilitationOther
Six weeks of cardiac rehabilitation with physical training
| Study group | Role | What they receive |
|---|---|---|
| Patient after first acute myocardial infarction | Not described Receives: Other: Cardiac rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and after 6 weeks of rehabilitation
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
Measured: Baseline and after 6 weeks of rehabilitation
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.
Measured: Baseline and after 6 weeks of rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start2 May 2023
- Primary completion12 Jun 2024
- Study completion13 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial Infarction: Rehabilitation PhaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298513
- Sponsor's protocol ID
- 09C338
- Acronym
- RIABILITOMICA
- Status last verified
- Aug 2025
- First submitted
- 1 Mar 2024
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic and Metabolic Response to Cardiac Rehabilitation After Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT06298513
- Acronym / sponsor ID
- RIABILITOMICA / 09C338
- Keywords
- myocardial infarction, cardiac rehabilitation, metabolomic, autonomic nervous ststem
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 12 Jun 2024 (actual)
- Study completion
- 13 Jan 2025 (actual)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient after first acute myocardial infarction | – | Other: Cardiac rehabilitation |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients meeting the eligibility criteria will be proposed to participate in the study
Key inclusion criteria (1 listed)
- recent first acute myocardial infarction
Key exclusion criteria (1 listed)
- severe diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac rehabilitationSix weeks of cardiac rehabilitation with physical training | Other | Patient after first acute myocardial infarction |
Primary outcome
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.
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction: Rehabilitation Phase, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in purine after rehabilitation (time frame: Baseline and after 6 weeks of rehabilitation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.