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The Physical Activity Post Myocardial Infarction SWEDEHEART Prospective Cohort Study

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05339477
Acronym
ACTIVITY
Enrollment
4000
Registered
2022-04-21
Start date
2022-04-26
Completion date
2029-04-26
Last updated
2025-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Keywords

physical activity, Accelerometer, Registry

Brief summary

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

OTHERAccelerometer 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 visit at 1 year.

Sponsors

Sahlgrenska University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Major adverse cardiovascular event (MACE)1 year after the index cardiac eventThe composite incidence of cardiovascular mortality, non-fatal myocardial infarction, non-fatal ischemic stroke, coronary revascularization, hospitalization for new or worsening heart failure

Secondary

MeasureTime frameDescription
Non-fatal myocardial infarction1 year after the index cardiac eventIncidence of non-fatal myocardial infarction
Non-fatal ischemic stroke1 year after the index cardiac eventIncidence of non-fatal ischemic stroke
Coronary revascularization1 year after the index cardiac eventIncidence of coronary revascularization
Cardiovascular mortality1 year after the index cardiac eventIncidence of cardiovascular mortality
Major adverse cardiovascular event (MACE)3 years after the index cardiac eventThe composite incidence of cardiovascular mortality, non-fatal myocardial infarction, non-fatal ischemic stroke, coronary revascularization, hospitalization for new or worsening heart failure
All-cause death1 year after the index cardiac eventIncidence of all-cause death
Heart failure1 year after the index cardiac eventIncidence of hospitalization for new or worsening heart failure

Other

MeasureTime frameDescription
Blood pressure1 year after the index cardiac eventmmHg
Smoking status1 year after the index cardiac event0=Never smoker, 1=Former smoker \> 1 month, 2=Smoker
Waist circumference1 year after the index cardiac eventcm
Body weight1 year after the index cardiac eventkg
The Swedish Healthy diet questionnaire1 year after the index cardiac eventFour questions with Likert scale 0-3 points. Higher scores indicate better outcomes
Health-related quality of life (EuroQol- 5 Dimension)1 year after the index cardiac eventEuroQol- 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.
Health-related quality of life (EQ visual analogue scale)1 year after the index cardiac eventEQ 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'.
Triglycerides1 year after the index cardiac eventPlasma levels of triglycerides (mmol/L). Higher values indicate worse outcome.
High-density lipoprotein (HDL) cholesterol1 year after the index cardiac eventPlasma levels of HDL (mmol/L). Higher values indicate better outcome
Low-density lipoprotein (LDL) cholesterol1 year after the index cardiac eventPlasma levels of LDL cholesterol (mmol/L). Higher values indicate worse outcome
Hemoglobin A1c (HbA1c)1 year after the index cardiac eventHbA1c (mmol/L). Measures the amount of blood sugar. Higher values indicate worse outcome

Countries

Sweden

Contacts

Primary ContactMaria Bäck, PhD
maria.m.back@vgregion.se+46313421195
Backup ContactJohanna Lilliecrona, MSc
johanna.lilliecrona@vgregion.se+46313421195

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026