Clinical trial NCT05339477: The Physical Activity Post Myocardial Infarction SWEDEHEART Prospective Cohort Study
Official title: The Physical Activity Post Myocardial Infarction SWEDEHEART Prospective Cohort Study (ACTIVITY-SWEDEHEART)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myocardial Infarction
Keywords: physical activity
Accelerometer
Registry
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with myocardial infarction will be recruited at the first (2 months after discharge) cardiac rehabilitation follow-up visit at hospital.

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.

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

Primary outcomes:
measure: Major adverse cardiovascular event (MACE)
timeFrame: 1 year after the index cardiac event
Secondary outcomes:
measure: Cardiovascular mortality
timeFrame: 1 year after the index cardiac event
measure: Non-fatal myocardial infarction
timeFrame: 1 year after the index cardiac event
measure: Non-fatal ischemic stroke
timeFrame: 1 year after the index cardiac event
measure: Coronary revascularization
timeFrame: 1 year after the index cardiac event
measure: Heart failure
timeFrame: 1 year after the index cardiac event
measure: Major adverse cardiovascular event (MACE)
timeFrame: 3 years after the index cardiac event
measure: Cardiovascular mortality
timeFrame: 3 years after the index cardiac event
measure: Non-fatal myocardial infarction
timeFrame: 3 years after the index cardiac event
measure: Non-fatal ischemic stroke
timeFrame: 3 years after the index cardiac event
measure: Coronary revascularization
timeFrame: 3 years after the index cardiac event
measure: Heart failure
timeFrame: 3 years after the index cardiac event
measure: All-cause death
timeFrame: 1 year after the index cardiac event
measure: All-cause death
timeFrame: 3 year after the index cardiac event
Other outcomes:
measure: Smoking status
timeFrame: 1 year after the index cardiac event
measure: The Swedish Healthy diet questionnaire
timeFrame: 1 year after the index cardiac event
measure: Health-related quality of life (EuroQol- 5 Dimension)
timeFrame: 1 year after the index cardiac event
measure: Health-related quality of life (EQ visual analogue scale)
timeFrame: 1 year after the index cardiac event
measure: Triglycerides
timeFrame: 1 year after the index cardiac event
measure: High-density lipoprotein (HDL) cholesterol
timeFrame: 1 year after the index cardiac event
measure: Low-density lipoprotein (LDL) cholesterol
timeFrame: 1 year after the index cardiac event
measure: Hemoglobin A1c (HbA1c)
timeFrame: 1 year after the index cardiac event
measure: Blood pressure
timeFrame: 1 year after the index cardiac event
measure: Body weight
timeFrame: 1 year after the index cardiac event
measure: Waist circumference
timeFrame: 1 year after the index cardiac event
Locations:
city: Alingsås
country: Sweden
facility: Alingsås lasarett
city: Bollnäs
country: Sweden
facility: Bollnäs sjukhus
city: Bäckefors
country: Sweden
facility: NU-sjukvården Dalslands sjukhus
city: Eksjö
country: Sweden
facility: Höglandssjukhuset Eksjö
city: Enköping
country: Sweden
facility: Lasarettet Enköping
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital Sahlgrenska
city: Gävle
country: Sweden
facility: Gävle sjukhus
city: Helsingborg
country: Sweden
facility: Helsingborgs lasarett
city: Jönköping
country: Sweden
facility: Jönköping Ryhov Hospital
city: Kalix
country: Sweden
facility: Kalix sjukhus
city: Kalmar
country: Sweden
facility: Länssjukhuset Kalmar
city: Karlstad
country: Sweden
facility: Centralsjukhuset Karlstad
city: Katrineholm
country: Sweden
facility: Kullbergska sjukhuset
city: Köping
country: Sweden
facility: Västmanlands sjukhus Köping
city: Linköping
country: Sweden
facility: Universitetssjukhuset Linköping
city: Luleå
country: Sweden
facility: Sunderby sjukhus
city: Lysekil
country: Sweden
facility: NU-sjukvården Lysekil
city: Malmö
country: Sweden
facility: Skåne Universitetssjukhus Malmö
city: Norrköping
country: Sweden
facility: Vrinnevisjukhuset
city: Oskarshamn
country: Sweden
facility: Oskarshamns sjukhus
city: Sala
country: Sweden
facility: Västmanlands sjukhus Sala
city: Sandviken
country: Sweden
facility: Sandvikens sjukhus
city: Simrishamn
country: Sweden
facility: Capio Närsjukhus Simrishamn
city: Skövde
country: Sweden
facility: Skaraborgs sjukhus Skövde
city: Stockholm
country: Sweden
facility: Capio St Göran
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Solna and Huddinge
city: Stockholm
country: Sweden
facility: Södersjukhuset
city: Strömstad
country: Sweden
facility: NU-sjukvården Strömstad
city: Söderhamn
country: Sweden
facility: Söderhamns sjukhus
city: Umeå
country: Sweden
facility: Norrlands Universitetssjukhus Umeå
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset
city: Varberg
country: Sweden
facility: Hallands sjukhus Varberg
city: Visby
country: Sweden
facility: Visby Lasarett
city: Värnamo
country: Sweden
facility: Värnamo sjukhus
city: Västervik
country: Sweden
facility: Västerviks sjukhus
Study officials:
affiliation: Department of physiotherapy, Sahlgrenska University Hospital
name: Maria Bäck, PhD
role: PRINCIPAL_INVESTIGATOR
References: