NCT04183465Active, not recruiting
Physical Activity Intervention in ELderly Patients With Myocardial INfarction
Effectiveness of an Early, Tailored, Physical Activity Intervention in ELderly Patients With Myocardial INfarction: the PIpELINe Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 23 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 512 (actual)
- First submitted
- 27 Nov 2019
- Start date
- 27 Mar 2020
- Primary completion date
- 30 Nov 2024
- Lead sponsor
- University Hospital of Ferrara
- Diseases
- Coronary artery disease
- NCT number
- NCT04183465
What you commit to
- Study type: Interventional
- Participants enrolled: 512
- From 27 Mar 2020 to the primary completion date, 30 Nov 2024
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Multivessel coronary artery disease or left main coronary artery disease candidate to surgical revascularization
- Severe aortic or mitral disease
- Chronic heart failure New York Heart Association (NYHA) III-IV
- Severe cognitive impairment (SPMSQ \<4)
- Impossibility to do physical activity due to physical impairment
Lab values
- Ejection fraction \<30%
Other
- Planned staged percutaneous coronary intervention (PCI)
- Non-cardiovascular co-morbidity reducing life expectancy to \< 1 year
- Any factor precluding 1-year follow-up
Who the study is looking for
- 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
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medicina dello Sport SSD Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| UO Cardiologia, Ospedale Maggiore Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| Centro Studi Biomedici applicati allo Sport, Ferrara Coordinator of this site? Confirm its status | Ferrara | Italy | Unknown status |
| Cardiology Unit Coordinator of this site? Confirm its status | Ferrara | Italy | Unknown status |
| Cardiologia Riabilitativa, AUSL d Ferrara Coordinator of this site? Confirm its status | Lagosanto | Italy | Unknown status |
| Medicina dello Sport, AUSL Piacenza Coordinator of this site? Confirm its status | Piacenza | Italy | Unknown status |
| Ospedale "Guglielmo Da Saliceto" Piacenza Coordinator of this site? Confirm its status | Piacenza | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.