Myocardial InfarctionPIpELINeNCT04183465
Physical Activity Intervention in ELderly Patients With Myocardial INfarction
A study testing Health Education and Multi-domain lifestyle intervention in people with Myocardial Infarction and Aging, run by University Hospital of Ferrara at 7 sites in Italy.
Trial summary
Elderly patients presenting with myocardial infarction (MI) are the highest risk population with the worst prognosis. No trial has ever been designed to optimize their outcome through a systematic improvement of their physical performance. Cardiac rehabilitation demonstrated to improve prognosis of patients after MI. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Myocardial Infarction, Aging
- What is being tested?
- Health Education and Multi-domain lifestyle intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 512 participants
- Where
- 7 sitesItaly
- Study dates
- 27 Mar 2020to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients ≥65 years
- Hospital admission for myocardial infarction
- Invasive management during index hospitalization including coronary artery angiography (± percutaneous coronary revascularization)
- SPPB value 4-9 at 1-month visit after hospital discharge
- Informed consent
Who cannot join
- Multivessel coronary artery disease or left main coronary artery disease candidate to surgical revascularization
- Planned staged percutaneous coronary intervention (PCI)
- Non-cardiovascular co-morbidity reducing life expectancy to < 1 year
- Any factor precluding 1-year follow-up
- Severe aortic or mitral disease
- Ejection fraction <30%
Show all 9Show fewer
- Chronic heart failure New York Heart Association (NYHA) III-IV
- Severe cognitive impairment (SPMSQ <4)
- Impossibility to do physical activity due to physical impairment
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Italy7 sites
Medicina dello Sport SSD
Bologna, BO
UO Cardiologia, Ospedale Maggiore
Bologna
Centro Studi Biomedici applicati allo Sport, Ferrara
Ferrara, FE
Cardiology Unit
Ferrara
Cardiologia Riabilitativa, AUSL d Ferrara
Lagosanto
Ospedale Guglielmo da Saliceto, Piacenza
Piacenza, PC
Medicina dello Sport, AUSL Piacenza
Piacenza
About this study
Official title: Effectiveness of an Early, Tailored, Physical Activity Intervention in ELderly Patients With Myocardial INfarction: the PIpELINe Randomized Clinical Trial
Elderly patients presenting with myocardial infarction (MI) are the highest risk population with the worst prognosis. No trial has ever been designed to optimize their outcome through a systematic improvement of their physical performance. Cardiac rehabilitation demonstrated to improve prognosis of patients after MI. However, real-life data shows that older patients are not referred to rehabilitation centers or they have low rate of attendance because of the high number of rehabilitation sessions and of logistic problems. So, data about effectiveness of rehabilitation programs in older MI patients is lacking.
The "Physical Activity Intervention for Elderly Patients with Reduced Physical Performance after acute coronary syndrome (HULK)" pilot study (NCT03021044) enrolled older MI patients and it demonstrated the feasibility and effectiveness of an early, tailored and low-cost physical activity intervention in terms of physical performance assessed by Short Physical Performance Battery (SPPB) score, that is strongly related to prognosis. The HULK study was focused on exercise training and not powered for hard endpoints. If a multi-domain lifestyle intervention in an adequately powered study may further improve prognosis is unknown. Thus, the investigator's hypothesis for the PIpELINe trial is that an early, tailored and low-cost multi-domain lifestyle intervention may improve prognosis of older MI patients compared to health education alone. The primary outcome is a composite of 1-year cardiovascular death and hospital readmission for cardiovascular cause.
Read the detailed description
The PIpELINe trial will include older MI patients. All patients aged 65 years and older undergoing coronary angiography because of MI must be screened for eligibility. Patient's eligibility must be assessed after percutaneous revascularization of all lesions considered susceptible of treatment. After verifying inclusion and exclusion criteria and after eligibility is confirmed, written informed consent must be obtained prior to randomization. At the time of the discharge (T0) SPPB test will be performed; in case of a score between 4 and 9, the patient will be evaluated 1-month after discharge at the inclusion visit (T1). If SPPB value is confirmed to be between 4 and 9, randomization will be performed. Key baseline patient characteristics (i.e., inclusion/exclusion criteria, demographics, medical history, details of cardiovascular anatomy and of revascularization, ECG and laboratory test results, echocardiographic data during the index hospitalization) will be recorded on the electronic Case Report Forms (eCRF). All angiographic and echocardiographic data will be collected and forwarded to a core lab for further assessment.
Randomization will be performed during the inclusion visit (T1), 30 days after discharge. Randomization will be performed centrally using an internet-based system. The patient identification number (Patient ID) and the treatment allocation will be assigned by the central randomization system. Patients will be randomized to physical activity group or health education group by a 2:1 allocation. Treatment allocation will be assigned according to a computer-generated randomization list stratified by center. All randomized patients are irrevocably in the study, whether or not they are subsequently found to be eligible, or actually receiving the allocated treatment. Therefore, all patients must be followed until the pre-specified study end date.
The aim of the study is to demonstrate that the proposed multi-domain lifestyle intervention reduces the composite endpoint of cardiovascular death and hospital readmission for cardiovascular cause. The primary endpoint is at 1 year. The follow-up will be extended up to 2 and 3 years.
The protocol includes 3 pre-specified substudies. The possibility to participate in the substudy is left to patient's decision and doesn't preclude the procedures of the main protocol.
- Anxiety and depression: previous studies reported an association between cardiovascular events and a subsequent appearance of mood disorders which could determine a lack in following secondary prevention recommendations. No data is available about these disorders in older adults. In order to assess depression after MI in older patients and the effect of physical activity intervention on mood disorders, this sub-study will be performed.
- Mitochondrial function: in both study groups the mitochondrial functional are investigated starting from blood samples and skin biopsy. Skin biopsy is performed to obtain fibroblasts. In-vitro assessment of the mitochondrial function is done on the fibroblasts of patients. The parameters obtained are related with the effectiveness of physical intervention and with the benefit obtained. A total of at least 30 patients is required.
- Lymphocyte and miRNA activity: taking into account the immunosenescence and the benefits of physical activity on the immune system, this sub-study aims to obtain data regarding T-lymphocyte function in older adults and to assess the effect of physical activity intervention on the function of the different groups of T-lymphocyte. Analyses of physical activity effects on micro ribonucleic acids (miRNAs) are also performed.
- Conditions
- Myocardial Infarction, Aging
- Being tested
- Health Education, Multi-domain lifestyle intervention
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health EducationOther
Current gold standard in older patients admitted to hospital for MI. The group will receive a 20-minute session with one of the study physicians. Both the patient and relatives will attend these sessions. The study physician will stress the major issues related to a heart-healthy lifestyle and will explain the importance of PA as a powerful and independent factor to improve cardiovascular health and minimize cardiovascular risk. A detailed brochure explaining the benefits of physical activity will be provided to all patients
Multi-domain lifestyle interventionOther
The intervention includes diet counselling, smoke cessation program, aggressive CV risk control and PA intervention. The PA intervention consisted of supervised sessions combined with an individualized home-based PA program. Centre-based sessions will be supervised by a sports physician and a nurse, and will take approximately 30 to 40 minutes, including a moderate standardized treadmill-walk, and strength and balance exercises. Based on the practice sessions, patients will receive a walking program to perform at home, unsupervised. The PA programs will be individualized, and consistent with current international recommendations. A selection of calisthenic exercises will be prescribed. Participants will be encouraged to perform the exercises three times per week (approximately 20 minutes). Adjustment of the type and intensity of the home-based PA regimen will be made at each visit. The PA program will be extensively described to the patient and family members.
| Study group | Role | What they receive |
|---|---|---|
| Health Education | Active comparator | All patients randomized to health education received a single in-person visit, one month post discharge, which included a 30-minute counselling session, supported by educational materials and tailoring of the medical treatment. The educational material provided standardized recommendations on diet, smoking cessation, and physical activity. Quality of life, functional capacity and home physical activity are assessed by proper tools. Receives: Other: Health Education |
| Multi-domain lifestyle intervention | Experimental | All patients randomized to experimental arm will receive diet counselling, aggressive control of CV risk factors, smoke cessation program and exercise training. The physical activity (PA) intervention will start the program with a supervised PA session immediately after the inclusion visit. Quality of life, functional capacity and daily activities will be assessed by proper tools. The program provides 6 supervised PA sessions (30, 60, 90, 180, 270 and 360 days after hospital discharge [T0]). At the end of each supervised session, calisthenics exercises derived from Otago Exercise Program are prescribed. Receives: Other: Multi-domain lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative occurrence of cardiovascular death and hospital readmission for cardiovascular cause
To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of 1-year composite endpoint of cardiovascular death plus hospital readmission for cardiovascular cause.
Measured: 1-year
Secondary outcomes (21)
Cumulative occurrence of all-cause death
To test the superiority of the early and tailored physical activity intervention over the health education alone in terms of all-cause death
Measured: 1-year
Cumulative occurrence of all-cause death
To test the superiority of the early and tailored physical activity intervention over the health education alone in terms of all-cause death
Measured: 3-year
Cumulative occurrence of cardiovascular death
To test the superiority of the early and tailored physical activity intervention over the health education alone in terms of cardiovascular death
Measured: 1-year
Cumulative occurrence of cardiovascular death
To test the superiority of the early and tailored physical activity intervention over the health education alone in terms of cardiovascular death
Measured: 3-year
Cumulative occurrence of hospital readmission for cardiovascular cause
To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of hospital readmission for cardiovascular cause.
Measured: 1-year
Cumulative occurrence of hospital readmission for cardiovascular cause
To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of composite endpoint of hospital readmission for cardiovascular cause.
Measured: 3-year
Cumulative occurrence of cardiovascular death and hospital readmission for cardiovascular cause
To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of composite endpoint of cardiovascular death plus hospital readmission for cardiovascular cause.
Measured: 3-year
Cumulative occurrence of hospital readmission for heart failure
To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of hospital readmission for heart failure
Measured: 1-year
Cumulative occurrence of hospital readmission for heart failure
To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of hospital readmission for heart failure
Measured: 3-year
Cumulative occurrence of hospital readmission for myocardial infarction
To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of hospital readmission for myocardial infarction
Measured: 1-year
Cumulative occurrence of hospital readmission for myocardial infarction
To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of hospital readmission for myocardial infarction
Measured: 3-year
Cumulative occurrence of hospital readmission for coronary revascularization
To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of hospital readmission for coronary revascularization
Measured: 1-year
Cumulative occurrence of hospital readmission for coronary revascularization
To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of hospital readmission for coronary revascularization
Measured: 3-year
Cumulative occurrence of cerebrovascular accident
To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of cerebrovascular accident
Measured: 1-year
Cumulative occurrence of cerebrovascular accident
To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of cerebrovascular accident
Measured: 3-year
Cumulative occurrence of hospital readmission for any cause
To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of hospital readmission for any cause
Measured: 1-year
Cumulative occurrence of hospital readmission for any cause
To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of hospital readmission for any cause
Measured: 3-year
Cumulative occurrence of hospital readmission for any non-cardiovascular cause
To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of hospital readmission for any non-cardiovascular cause
Measured: 1-year
Cumulative occurrence of hospital readmission for any non-cardiovascular cause
To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of hospital readmission for any non-cardiovascular cause
Measured: 3-year
Cumulative occurrence of bleeding adverse events
To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of bleeding adverse events
Measured: 1-year
Cumulative occurrence of bleeding adverse events
To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of bleeding adverse events
Measured: 3-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start27 Mar 2020
- Primary completion30 Nov 2024
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 512 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Usl di Bologna, Azienda Unita Sanitaria Locale di Piacenza
- Responsible party
- Principal investigator, Gianluca Campo, University Hospital of Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183465
- Sponsor's protocol ID
- 376/2019/Sper/AOUFe
- Acronym
- PIpELINe
- Status last verified
- Jul 2025
- First submitted
- 27 Nov 2019
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Tonet E, Raisi A, Zagnoni S, Chiaranda G, Pavasini R, Vitali F, Gibiino F, Campana R, Boccadoro A, Scala A, Canovi L, Amantea V, Matese C, Berloni ML, Piva T, Zerbini V, Cardelli LS, Pasanisi G, Mazzoni G, Casella G, Grazzi G, Campo G. Multi-domain lifestyle intervention in older adults after myocardial infarction: rationale and design of the PIpELINe randomized clinical trial. Aging Clin Exp Res. 2023 May;35(5):1107-1115. doi: 10.1007/s40520-023-02389-9. Epub 2023 Mar 25.
PubMed 36964866Dal Passo B, Tonet E, Raisi A, Zagnoni S, Chiaranda G, Pasanisi G, Pavasini R, Cimaglia P, Piva T, Casella G, Caglioni S, Zerbini V, Cocco M, Menegatti E, Mandini S, Mazzoni G, Biscaglia S, Volpato S, Grazzi G, Campo G. Effectiveness of Multidomain Cardiac Rehabilitation After Myocardial Infarction by Patient Frailty: Prespecified Subgroup Analysis of the PIpELINe Trial. Circ Popul Health Outcomes. 2026 Aug 17:e013410. doi: 10.1161/CIRCOUTCOMES.126.013410. Online ahead of print.
PubMed 42605666Tonet E, Raisi A, Zagnoni S, Chiaranda G, Pasanisi G, Aschieri D, D'Intino PE, Pavasini R, Cimaglia P, Campana R, Vitali F, Piva T, Casella G, Caglioni S, Zerbini V, Bugani G, Cocco M, Menegatti E, De Raffele M, Mandini S, Martella D, Pesenti N, Mazzoni G, Biscaglia S, Volpato S, Grazzi G, Campo G; PIpELINe Trial Investigators. Multidomain Rehabilitation for Older Patients with Myocardial Infarction. N Engl J Med. 2025 Sep 11;393(10):973-982. doi: 10.1056/NEJMoa2502799. Epub 2025 Aug 29.
PubMed 40879431
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Early, Tailored, Physical Activity Intervention in ELderly Patients With Myocardial INfarction: the PIpELINe Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04183465
- Acronym / sponsor ID
- PIpELINe / 376/2019/Sper/AOUFe
- Conditions
- Myocardial Infarction, Aging
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 512 participants (actual)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Collaborators
- Azienda Usl di Bologna, Azienda Unita Sanitaria Locale di Piacenza
- Study start
- 27 Mar 2020 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 3 Dec 2019 (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.
Elderly patients presenting with myocardial infarction (MI) are the highest risk population with the worst prognosis. No trial has ever been designed to optimize their outcome through a systematic improvement of their physical performance. Cardiac rehabilitation demonstrated to improve prognosis of patients after MI. However, real-life data shows that older patients are not referred to rehabilitation centers or they have low rate of attendance because of the high number of rehabilitation sessions and of logistic problems. So, data about effectiveness of rehabilitation programs in older MI patients is lacking.
The "Physical Activity Intervention for Elderly Patients with Reduced Physical Performance after acute coronary syndrome (HULK)" pilot study (NCT03021044) enrolled older MI patients and it demonstrated the feasibility and effectiveness of an early, tailored and low-cost physical activity intervention in terms of physical performance assessed by Short Physical Performance Battery (SPPB) score, that is strongly related to prognosis. The HULK study was focused on exercise training and not powered for hard endpoints. If a multi-domain lifestyle intervention in an adequately powered study may further improve prognosis is unknown. Thus, the investigator's hypothesis for the PIpELINe trial is that an early, tailored and low-cost multi-domain lifestyle intervention may improve prognosis of older MI patients compared to health education alone. The primary outcome is a composite of 1-year cardiovascular death and hospital readmission for cardiovascular cause.
Detailed description
The PIpELINe trial will include older MI patients. All patients aged 65 years and older undergoing coronary angiography because of MI must be screened for eligibility. Patient's eligibility must be assessed after percutaneous revascularization of all lesions considered susceptible of treatment. After verifying inclusion and exclusion criteria and after eligibility is confirmed, written informed consent must be obtained prior to randomization. At the time of the discharge (T0) SPPB test will be performed; in case of a score between 4 and 9, the patient will be evaluated 1-month after discharge at the inclusion visit (T1). If SPPB value is confirmed to be between 4 and 9, randomization will be performed. Key baseline patient characteristics (i.e., inclusion/exclusion criteria, demographics, medical history, details of cardiovascular anatomy and of revascularization, ECG and laboratory test results, echocardiographic data during the index hospitalization) will be recorded on the electronic Case Report Forms (eCRF). All angiographic and echocardiographic data will be collected and forwarded to a core lab for further assessment.
Randomization will be performed during the inclusion visit (T1), 30 days after discharge. Randomization will be performed centrally using an internet-based system. The patient identification number (Patient ID) and the treatment allocation will be assigned by the central randomization system. Patients will be randomized to physical activity group or health education group by a 2:1 allocation. Treatment allocation will be assigned according to a computer-generated randomization list stratified by center. All randomized patients are irrevocably in the study, whether or not they are subsequently found to be eligible, or actually receiving the allocated treatment. Therefore, all patients must be followed until the pre-specified study end date.
The aim of the study is to demonstrate that the proposed multi-domain lifestyle intervention reduces the composite endpoint of cardiovascular death and hospital readmission for cardiovascular cause. The primary endpoint is at 1 year. The follow-up will be extended up to 2 and 3 years.
The protocol includes 3 pre-specified substudies. The possibility to participate in the substudy is left to patient's decision and doesn't preclude the procedures of the main protocol.
- Anxiety and depression: previous studies reported an association between cardiovascular events and a subsequent appearance of mood disorders which could determine a lack in following secondary prevention recommendations. No data is available about these disorders in older adults. In order to assess depression after MI in older patients and the effect of physical activity intervention on mood disorders, this sub-study will be performed.
- Mitochondrial function: in both study groups the mitochondrial functional are investigated starting from blood samples and skin biopsy. Skin biopsy is performed to obtain fibroblasts. In-vitro assessment of the mitochondrial function is done on the fibroblasts of patients. The parameters obtained are related with the effectiveness of physical intervention and with the benefit obtained. A total of at least 30 patients is required.
- Lymphocyte and miRNA activity: taking into account the immunosenescence and the benefits of physical activity on the immune system, this sub-study aims to obtain data regarding T-lymphocyte function in older adults and to assess the effect of physical activity intervention on the function of the different groups of T-lymphocyte. Analyses of physical activity effects on micro ribonucleic acids (miRNAs) are also performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Education | Active comparator | Other: Health EducationAll patients randomized to health education received a single in-person visit, one month post discharge, which included a 30-minute counselling session, supported by educational materials and tailoring of the medical treatment. The educational material provided standardized recommendations on diet, smoking cessation, and physical activity. Quality of life, functional capacity and home physical activity are assessed by proper tools. |
| Multi-domain lifestyle intervention | Experimental | Other: Multi-domain lifestyle interventionAll patients randomized to experimental arm will receive diet counselling, aggressive control of CV risk factors, smoke cessation program and exercise training. The physical activity (PA) intervention will start the program with a supervised PA session immediately after the inclusion visit. Quality of life, functional capacity and daily activities will be assessed by proper tools. The program provides 6 supervised PA sessions (30, 60, 90, 180, 270 and 360 days after hospital discharge [T0]). At the end of each supervised session, calisthenics exercises derived from Otago Exercise Program are prescribed. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Patients ≥65 years
- Hospital admission for myocardial infarction
- Invasive management during index hospitalization including coronary artery angiography (± percutaneous coronary revascularization)
- SPPB value 4-9 at 1-month visit after hospital discharge
- Informed consent
Key exclusion criteria (9 listed)
- Multivessel coronary artery disease or left main coronary artery disease candidate to surgical revascularization
- Planned staged percutaneous coronary intervention (PCI)
- Non-cardiovascular co-morbidity reducing life expectancy to < 1 year
- Any factor precluding 1-year follow-up
- Severe aortic or mitral disease
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 |
|---|---|---|
| Health EducationCurrent gold standard in older patients admitted to hospital for MI. The group will receive a 20-minute session with one of the study physicians. Both the patient and relatives will attend these sessions. The study physician will stress the major issues related to a heart-healthy lifestyle and will explain the importance of PA as a powerful and independent factor to improve cardiovascular health and minimize cardiovascular risk. A detailed brochure explaining the benefits of physical activity will be provided to all patients | Other | Health Education |
| Multi-domain lifestyle interventionThe intervention includes diet counselling, smoke cessation program, aggressive CV risk control and PA intervention. The PA intervention consisted of supervised sessions combined with an individualized home-based PA program. Centre-based sessions will be supervised by a sports physician and a nurse, and will take approximately 30 to 40 minutes, including a moderate standardized treadmill-walk, and strength and balance exercises. Based on the practice sessions, patients will receive a walking program to perform at home, unsupervised. The PA programs will be individualized, and consistent with current international recommendations. A selection of calisthenic exercises will be prescribed. Participants will be encouraged to perform the exercises three times per week (approximately 20 minutes). Adjustment of the type and intensity of the home-based PA regimen will be made at each visit. The PA program will be extensively described to the patient and family members. | Other | Multi-domain lifestyle intervention |
Primary outcome
Cumulative occurrence of cardiovascular death and hospital readmission for cardiovascular cause
Time frame: 1-year
To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of 1-year composite endpoint of cardiovascular death plus hospital readmission for cardiovascular cause.
21 secondary outcomes
Cumulative occurrence of all-cause death
Time frame: 1-year
Cumulative occurrence of all-cause death
Time frame: 3-year
Cumulative occurrence of cardiovascular death
Time frame: 1-year
Cumulative occurrence of cardiovascular death
Time frame: 3-year
Cumulative occurrence of hospital readmission for cardiovascular cause
Time frame: 1-year
Cumulative occurrence of hospital readmission for cardiovascular cause
Time frame: 3-year
Cumulative occurrence of cardiovascular death and hospital readmission for cardiovascular cause
Time frame: 3-year
Cumulative occurrence of hospital readmission for heart failure
Time frame: 1-year
Cumulative occurrence of hospital readmission for heart failure
Time frame: 3-year
Cumulative occurrence of hospital readmission for myocardial infarction
Time frame: 1-year
Cumulative occurrence of hospital readmission for myocardial infarction
Time frame: 3-year
Cumulative occurrence of hospital readmission for coronary revascularization
Time frame: 1-year
Cumulative occurrence of hospital readmission for coronary revascularization
Time frame: 3-year
Cumulative occurrence of cerebrovascular accident
Time frame: 1-year
Cumulative occurrence of cerebrovascular accident
Time frame: 3-year
Cumulative occurrence of hospital readmission for any cause
Time frame: 1-year
Cumulative occurrence of hospital readmission for any cause
Time frame: 3-year
Cumulative occurrence of hospital readmission for any non-cardiovascular cause
Time frame: 1-year
Cumulative occurrence of hospital readmission for any non-cardiovascular cause
Time frame: 3-year
Cumulative occurrence of bleeding adverse events
Time frame: 1-year
Cumulative occurrence of bleeding adverse events
Time frame: 3-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Results publication: PubMed 36964866Tonet E, Raisi A, Zagnoni S, Chiaranda G, Pavasini R, Vitali F, Gibiino F, Campana R, Boccadoro A, Scala A, Canovi L, Amantea V, Matese C, Berloni ML, Piva T, Zerbini V, Cardelli LS, Pasanisi G, Mazzoni G, Casella G, Grazzi G, Campo G. Multi-domain lifestyle intervention in older adults after myocardial infarction: rationale and design of the PIpELINe randomized clinical trial. Aging Clin Exp Res. 2023 May;35(5):1107-1115. doi: 10.1007/s40520-023-02389-9. Epub 2023 Mar 25.
- Derived from this study: PubMed 42605666Dal Passo B, Tonet E, Raisi A, Zagnoni S, Chiaranda G, Pasanisi G, Pavasini R, Cimaglia P, Piva T, Casella G, Caglioni S, Zerbini V, Cocco M, Menegatti E, Mandini S, Mazzoni G, Biscaglia S, Volpato S, Grazzi G, Campo G. Effectiveness of Multidomain Cardiac Rehabilitation After Myocardial Infarction by Patient Frailty: Prespecified Subgroup Analysis of the PIpELINe Trial. Circ Popul Health Outcomes. 2026 Aug 17:e013410. doi: 10.1161/CIRCOUTCOMES.126.013410. Online ahead of print.
- Derived from this study: PubMed 40879431Tonet E, Raisi A, Zagnoni S, Chiaranda G, Pasanisi G, Aschieri D, D'Intino PE, Pavasini R, Cimaglia P, Campana R, Vitali F, Piva T, Casella G, Caglioni S, Zerbini V, Bugani G, Cocco M, Menegatti E, De Raffele M, Mandini S, Martella D, Pesenti N, Mazzoni G, Biscaglia S, Volpato S, Grazzi G, Campo G; PIpELINe Trial Investigators. Multidomain Rehabilitation for Older Patients with Myocardial Infarction. N Engl J Med. 2025 Sep 11;393(10):973-982. doi: 10.1056/NEJMoa2502799. Epub 2025 Aug 29.
- Individual participant dataSharing planned: Yes
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Education and Multi-domain lifestyle intervention in people with Myocardial Infarction and Aging, run by University Hospital of Ferrara at 7 sites 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 5 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Cumulative occurrence of cardiovascular death and hospital readmission for cardiovascular cause (time frame: 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04183465, which also lists 3 linked publications.
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 23 Jul 2025.