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NCT Number: NCT05339477

The Physical Activity Post Myocardial Infarction SWEDEHEART Prospective Cohort Study

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.

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Key information

Conditions

Myocardial Infarction Behavior Cardiovascular Diseases Heart Diseases Infarction Ischemia Motor Activity Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Alingsås lasarett, Alingsås, Sweden

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Accelerometer measurement

Other

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 visit at 1 year.

Primary outcomes

  1. Major adverse cardiovascular event (MACE)

    Time frame: 1 year after the index cardiac event

    The composite incidence of cardiovascular mortality, non-fatal myocardial infarction, non-fatal ischemic stroke, coronary revascularization, hospitalization for new or worsening heart failure

Secondary outcomes

  1. Cardiovascular mortality

    Time frame: 1 year after the index cardiac event

    Incidence of cardiovascular mortality

  2. Non-fatal myocardial infarction

    Time frame: 1 year after the index cardiac event

    Incidence of non-fatal myocardial infarction

  3. Non-fatal ischemic stroke

    Time frame: 1 year after the index cardiac event

    Incidence of non-fatal ischemic stroke

  4. Coronary revascularization

    Time frame: 1 year after the index cardiac event

    Incidence of coronary revascularization

  5. Heart failure

    Time frame: 1 year after the index cardiac event

    Incidence of hospitalization for new or worsening heart failure

  6. Major adverse cardiovascular event (MACE)

    Time frame: 3 years after the index cardiac event

    The composite incidence of cardiovascular mortality, non-fatal myocardial infarction, non-fatal ischemic stroke, coronary revascularization, hospitalization for new or worsening heart failure

  7. Cardiovascular mortality

    Time frame: 3 years after the index cardiac event

    Incidence of cardiovascular mortality

  8. Non-fatal myocardial infarction

    Time frame: 3 years after the index cardiac event

    Incidence of non-fatal myocardial infarction

  9. Non-fatal ischemic stroke

    Time frame: 3 years after the index cardiac event

    Incidence of non-fatal ischemic stroke

  10. Coronary revascularization

    Time frame: 3 years after the index cardiac event

    Incidence of coronary revascularization

  11. Heart failure

    Time frame: 3 years after the index cardiac event

    Incidence of hospitalization for new or worsening heart failure

  12. All-cause death

    Time frame: 1 year after the index cardiac event

    Incidence of all-cause death

  13. All-cause death

    Time frame: 3 year after the index cardiac event

    Incidence of all-cause death

Other outcomes

  1. Smoking status

    Time frame: 1 year after the index cardiac event

    0=Never smoker, 1=Former smoker > 1 month, 2=Smoker

  2. The Swedish Healthy diet questionnaire

    Time frame: 1 year after the index cardiac event

    Four questions with Likert scale 0-3 points. Higher scores indicate better outcomes

  3. Health-related quality of life (EuroQol- 5 Dimension)

    Time frame: 1 year after the index cardiac event

    EuroQol- 5 Dimension (EQ-5D-3L) The EQ-5D-3L comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Higher scores indicate better outcomes.

  4. Health-related quality of life (EQ visual analogue scale)

    Time frame: 1 year after the index cardiac event

    EQ visual analogue scale (EQ VAS). The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'.

  5. Triglycerides

    Time frame: 1 year after the index cardiac event

    Plasma levels of triglycerides (mmol/L). Higher values indicate worse outcome.

  6. High-density lipoprotein (HDL) cholesterol

    Time frame: 1 year after the index cardiac event

    Plasma levels of HDL (mmol/L). Higher values indicate better outcome

  7. Low-density lipoprotein (LDL) cholesterol

    Time frame: 1 year after the index cardiac event

    Plasma levels of LDL cholesterol (mmol/L). Higher values indicate worse outcome

  8. Hemoglobin A1c (HbA1c)

    Time frame: 1 year after the index cardiac event

    HbA1c (mmol/L). Measures the amount of blood sugar. Higher values indicate worse outcome

  9. Blood pressure

    Time frame: 1 year after the index cardiac event

    mmHg

  10. Body weight

    Time frame: 1 year after the index cardiac event

    kg

  11. Waist circumference

    Time frame: 1 year after the index cardiac event

    cm

Study contacts

Contact information is provided by the study sponsor or research team.

Johanna Lilliecrona, MSc

CONTACT

[email protected]

+46313421195

Maria Bäck, PhD

CONTACT

[email protected]

+46313421195

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Official study title

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

Acronym: ACTIVITY

Important dates

Study start
2022
Primary completion
2026
Study completion
2029
First posted
Apr 21, 2022
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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