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Myocardial InfarctionACTIVITYNCT05339477

The Physical Activity Post Myocardial Infarction SWEDEHEART Prospective Cohort Study

An observational study of Myocardial Infarction, run by Sahlgrenska University Hospital at 35 sites in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Myocardial Infarction
What is being tested?
Accelerometer measurement
How many people
4,000 participants
Where
35 sitesSweden
Study dates
26 Apr 2022to 26 Apr 2029
How long will I take part?
3 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with myocardial infarction will be recruited at the first (2 months after discharge) cardiac rehabilitation follow-up visit at hospital.

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

35 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Maria Bäck, PhD contact

+46313421195

maria.m.back@vgregion.se

Johanna Lilliecrona, MSc contact

+46313421195

johanna.lilliecrona@vgregion.se

35 sites in 1 country

Sweden35 sites, 33 recruiting

  • Alingsås lasarett

    Alingsås

    Petter Tollemark

    Recruiting

  • NU-sjukvården Dalslands sjukhus

    Bäckefors

    Madelene Andersson, madelene.l.backstrom@vgregion.se

    Recruiting

  • Bollnäs sjukhus

    Bollnäs

    Maria Östman

    Recruiting

  • Höglandssjukhuset Eksjö

    Eksjö

    Helene Warin

    Recruiting

  • Lasarettet Enköping

    Enköping

    Görel Stengård

    Recruiting

  • Gävle sjukhus

    Gävle

    Anna Cutler

    Not yet recruiting

  • Sahlgrenska University Hospital Sahlgrenska

    Gothenburg

    Maria Lachonius, RN, maria.lachonius@vgregion.se

    Recruiting

  • Helsingborgs lasarett

    Helsingborg

    Bjarne Madsen Härdig

    Recruiting

  • Jönköping Ryhov Hospital

    Jönköping

    Emma Hag, RN, emma.hag@rjl.se

    Recruiting

  • Kalix sjukhus

    Kalix

    Magdalena Engren Jonsson

    Recruiting

  • Länssjukhuset Kalmar

    Kalmar

    Charlotta Lans

    Recruiting

  • Centralsjukhuset Karlstad

    Karlstad

    Karin Arinell

    Recruiting

  • Kullbergska sjukhuset

    Katrineholm

    Hanna Hafström Eng

    Recruiting

  • Västmanlands sjukhus Köping

    Köping

    Marianne Ordell Schieman

    Recruiting

  • Universitetssjukhuset Linköping

    Linköping

    Sabina Borg

    Recruiting

  • Sunderby sjukhus

    Luleå

    Maarit Kylmamaa

    Recruiting

  • NU-sjukvården Lysekil

    Lysekil

    Marica Stenström

    Recruiting

  • Skåne Universitetssjukhus Malmö

    Malmö

    Margret Leosdottir

    Recruiting

  • Vrinnevisjukhuset

    Norrköping

    Withdrawn

  • Oskarshamns sjukhus

    Oskarshamn

    Sofi Karlsson

    Recruiting

  • Västmanlands sjukhus Sala

    Sala

    Marica Hallsten Larsson

    Recruiting

  • Sandvikens sjukhus

    Sandviken

    Anna Cutler

    Recruiting

  • Capio Närsjukhus Simrishamn

    Simrishamn

    Pernilla Rosberg Håkansson

    Recruiting

  • Skaraborgs sjukhus Skövde

    Skövde

    Frida Brevitz

    Recruiting

  • Söderhamns sjukhus

    Söderhamn

    Anna-Sara Raphael

    Not yet recruiting

  • Capio St Göran

    Stockholm

    Anneli Johansson

    Recruiting

  • Karolinska University Hospital Solna and Huddinge

    Stockholm

    Matthias Lidin, PhD, matthias.lidin@ki.se

    Recruiting

  • Södersjukhuset

    Stockholm

    Robin Hofmann

    Recruiting

  • NU-sjukvården Strömstad

    Strömstad

    Barbro Limnell

    Recruiting

  • Norrlands Universitetssjukhus Umeå

    Umeå

    Active, not recruiting

  • Akademiska sjukhuset

    Uppsala

    Emil Hagström

    Recruiting

  • Hallands sjukhus Varberg

    Varberg

    Frida Johansson

    Recruiting

  • Värnamo sjukhus

    Värnamo

    Monica Cederblad

    Recruiting

  • Västerviks sjukhus

    Västervik

    Emmy Cheruiyot Johansson

    Recruiting

  • Visby Lasarett

    Visby

    Amanda Wiberg, amanda.wiberg@gotland.se

    Not yet recruiting

Other trials in Sweden

About this study

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

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.

Read the 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.

Being tested
Accelerometer measurement
Keywords
physical activity, Accelerometer, Registry
Medical subject headings
Myocardial Infarction, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Accelerometer measurementOther

    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.

Study groups in NCT05339477
Study groupRoleWhat they receive
Cohort groupDiagnosis of a type 1 myocardial infarction registered in SWEDEHEART Age 18-79 years at discharge from hospital
Receives: Other: Accelerometer measurement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major adverse cardiovascular event (MACE)

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

    Measured: 1 year after the index cardiac event

Secondary outcomes (13)

  1. Cardiovascular mortality

    Incidence of cardiovascular mortality

    Measured: 1 year after the index cardiac event

  2. Non-fatal myocardial infarction

    Incidence of non-fatal myocardial infarction

    Measured: 1 year after the index cardiac event

  3. Non-fatal ischemic stroke

    Incidence of non-fatal ischemic stroke

    Measured: 1 year after the index cardiac event

  4. Coronary revascularization

    Incidence of coronary revascularization

    Measured: 1 year after the index cardiac event

  5. Heart failure

    Incidence of hospitalization for new or worsening heart failure

    Measured: 1 year after the index cardiac event

  6. Major adverse cardiovascular event (MACE)

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

    Measured: 3 years after the index cardiac event

  7. Cardiovascular mortality

    Incidence of cardiovascular mortality

    Measured: 3 years after the index cardiac event

  8. Non-fatal myocardial infarction

    Incidence of non-fatal myocardial infarction

    Measured: 3 years after the index cardiac event

  9. Non-fatal ischemic stroke

    Incidence of non-fatal ischemic stroke

    Measured: 3 years after the index cardiac event

  10. Coronary revascularization

    Incidence of coronary revascularization

    Measured: 3 years after the index cardiac event

  11. Heart failure

    Incidence of hospitalization for new or worsening heart failure

    Measured: 3 years after the index cardiac event

  12. All-cause death

    Incidence of all-cause death

    Measured: 1 year after the index cardiac event

  13. All-cause death

    Incidence of all-cause death

    Measured: 3 year after the index cardiac event

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2022
  2. Study start26 Apr 2022
  3. Primary completion26 Apr 2026 (estimated)
  4. Study completion26 Apr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
4,000 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05339477
Sponsor's protocol ID
277371
Acronym
ACTIVITY
Status last verified
Feb 2025
First submitted
10 Apr 2022
Last updated
11 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Myocardial Infarction, run by Sahlgrenska University Hospital at 35 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maria Bäck, PhD (+46313421195, maria.m.back@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major adverse cardiovascular event (MACE) (time frame: 1 year after the index cardiac event). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05339477.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.

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