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Recruiting NCT05339477

The Physical Activity Post Myocardial Infarction SWEDEHEART Prospective Cohort Study

— Observational Myocardial Infarction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Accelerometer measurement.
Who it may be relevant to
Registry conditions: Myocardial Infarction. Basic parameters: 18 years — 79 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Physical Activity Post Myocardial Infarction SWEDEHEART Prospective Cohort Study (ACTIVITY-SWEDEHEART)

Overview

The association between objectively measured physical activity intensities (light, moderate and vigorous), sedentary time and clinical outcomes has not been clarified in patients after a myocardial infarction. The overall objective of the study is to explore associations between accelerometer measured physical activity and clinical outcomes after a myocardial infarction. Moreover, the association between changes in physical activity and outcomes will be assessed.

Detailed description

It is estimated to include 4000 patients with myocardial infarction during 2 years. Patients will wear the accelerometer for 7 days at follow-up visits (2 months and 1 year) after discharge. The investigators will examine the dose-response relations of several exposure variables from the accelerometer measurements with the outcomes.

Interventions

  • Other Accelerometer measurement
    Study personnel will initiate an accelerometer and inform the patient to wear the accelerometer with an elastic belt on their right hip during waking hours for seven consecutive days. Moreover, patients are instructed to register their wear time in an activity diary in paper form. In addition, patients will register their working hours, if relevant. After seven days, patients send back the accelerometer and diary in a pre-paid envelope. The same procedure is repeated at the second follow-up visi

Primary outcome measures

  • Major adverse cardiovascular event (MACE) [Time frame: 1 year after the index cardiac event]
Secondary outcome measures (12)
  • Cardiovascular mortality [Time frame: 1 year after the index cardiac event]
  • Non-fatal myocardial infarction [Time frame: 1 year after the index cardiac event]
  • Non-fatal ischemic stroke [Time frame: 1 year after the index cardiac event]
  • Coronary revascularization [Time frame: 1 year after the index cardiac event]
  • Heart failure [Time frame: 1 year after the index cardiac event]
  • Major adverse cardiovascular event (MACE) [Time frame: 3 years after the index cardiac event]
  • Cardiovascular mortality [Time frame: 3 years after the index cardiac event]
  • Non-fatal myocardial infarction [Time frame: 3 years after the index cardiac event]
  • Non-fatal ischemic stroke [Time frame: 3 years after the index cardiac event]
  • Coronary revascularization [Time frame: 3 years after the index cardiac event]
  • Heart failure [Time frame: 3 years after the index cardiac event]
  • All-cause death [Time frame: 1 year after the index cardiac event]

Eligibility criteria

Inclusion criteria

  • Signed informed consent
  • Diagnosis of a type 1 myocardial infarction registered in SWEDEHEART
  • Age 18-79 years at discharge from hospital
  • Attending the first visit in the cardiac rehabilitation (CR) registry SEPHIA (2 months after discharge)

Exclusion criteria

  • Inability to understand Swedish
  • Non-ambulatory
  • Any mental condition that may interfere with the possibility for the patient to comply with the study protocol

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Sweden · 35 centers
  • Alingsås lasarett — Alingsås
  • NU-sjukvården Dalslands sjukhus — Bäckefors
  • Bollnäs sjukhus — Bollnäs
  • Höglandssjukhuset Eksjö — Eksjö
  • Lasarettet Enköping — Enköping
  • Gävle sjukhus — Gävle
  • Sahlgrenska University Hospital Sahlgrenska — Gothenburg
  • Helsingborgs lasarett — Helsingborg
  • … and 27 more centers

Identifiers

NCT: NCT05339477 · 277371

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗