NCT06298513

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2025

Completed
Last Updated

August 21, 2025

Status Verified

August 1, 2025

Enrollment Period

1.1 years

First QC Date

March 1, 2024

Last Update Submit

August 19, 2025

Conditions

Keywords

myocardial infarctioncardiac rehabilitationmetabolomicautonomic nervous ststem

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (1)

Patient after first acute myocardial infarction

Other: Cardiac rehabilitation

Interventions

Six weeks of cardiac rehabilitation with physical training

Patient after first acute myocardial infarction

Eligibility Criteria

Age25 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All consecutive patients meeting the eligibility criteria will be proposed to participate in the study

You may qualify if:

  • recent first acute myocardial infarction

You may not qualify if:

  • severe diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Auxologico Italiano

Milan, 20149, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

frozen plasma

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2024

First Posted

March 7, 2024

Study Start

May 2, 2023

Primary Completion

June 12, 2024

Study Completion

January 13, 2025

Last Updated

August 21, 2025

Record last verified: 2025-08

Locations