ClinicalTrials.gg
RecruitingNCT05339477ACTIVITYUpdated Feb 11, 2025

The Physical Activity Post Myocardial Infarction SWEDEHEART Prospective Cohort Study

An observational study in Myocardial Infarction, sponsored by Sahlgrenska University Hospital. Recruiting at 35 sites in Sweden. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2025-02-11.

Sponsored by Sahlgrenska University Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2026, 6 months ago, but the record still lists the study as recruiting.
  • Started Apr 2022; still recruiting 4 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4,000
Ages
18 Years to 79 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 90 studies in Myocardial Infarction with a site in Sweden — 13 open to participants now, 22 under way, 4 of them phase 3. Myocardial Infarction · Sweden.

Planned enrollment
11th of 20
4,000 · median 5,518
Started
2022
with 2 others
Observational
20 of 90
2 open now
Primary completion
2026-04
later than 7 of 21 live
Registered
73rd of 90
by date
Lead sponsor
5 of 90
Sahlgrenska University Hospital

Among the 90 studies in Myocardial Infarction with a site in Sweden, this one is the 11th largest by planned enrollment of the 20 observational ones that give a count, is one of 3 that started in 2022, is one of 20 observational ones, reaches primary completion later than 7 of the 21 other live ones, and was the 73rd registered.

Myocardial Infarction

2,270 studies on the registry are indexed under Myocardial Infarction; 371 are open to participants now.

Browse Myocardial Infarction studies →

Open to participants now

13 of the 90 studies in Myocardial Infarction with a site in Sweden are open now. Recruiting first, the newest first:

7 more — sign in →

All 13 open studies →

A study can be open while its sites in Sweden have not opened yet or have stopped. Only those recruiting at a site in Sweden →

Who these studies take

Of the 255 Myocardial Infarction studies recruiting now, 172 (67%) set no upper age limit and 26 (10%) stop at 75 or younger; 16 take children under 18; 27 take healthy volunteers.

This study: 18 Years to 79 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 90 studies in Myocardial Infarction with a site in Sweden, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

  • Myocardial Infarction

Keywords

  • physical activity
  • Accelerometer
  • Registry
04

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Signed
  • 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4,000 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes

Groups and cohorts

  • Cohort group

    Diagnosis of a type 1 myocardial infarction registered in SWEDEHEART Age 18-79 years at discharge from hospital

    Other: Accelerometer measurement

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.

06

What researchers measure

Primary outcomes

  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

    Time frame: 1 year after the index cardiac event

Secondary outcomes

  1. Cardiovascular mortality

    Incidence of cardiovascular mortality

    Time frame: 1 year after the index cardiac event

  2. Non-fatal myocardial infarction

    Incidence of non-fatal myocardial infarction

    Time frame: 1 year after the index cardiac event

  3. Non-fatal ischemic stroke

    Incidence of non-fatal ischemic stroke

    Time frame: 1 year after the index cardiac event

  4. Coronary revascularization

    Incidence of coronary revascularization

    Time frame: 1 year after the index cardiac event

  5. Heart failure

    Incidence of hospitalization for new or worsening heart failure

    Time frame: 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

    Time frame: 3 years after the index cardiac event

  7. Cardiovascular mortality

    Incidence of cardiovascular mortality

    Time frame: 3 years after the index cardiac event

  8. Non-fatal myocardial infarction

    Incidence of non-fatal myocardial infarction

    Time frame: 3 years after the index cardiac event

  9. Non-fatal ischemic stroke

    Incidence of non-fatal ischemic stroke

    Time frame: 3 years after the index cardiac event

  10. Coronary revascularization

    Incidence of coronary revascularization

    Time frame: 3 years after the index cardiac event

  11. Heart failure

    Incidence of hospitalization for new or worsening heart failure

    Time frame: 3 years after the index cardiac event

  12. All-cause death

    Incidence of all-cause death

    Time frame: 1 year after the index cardiac event

  13. All-cause death

    Incidence of all-cause death

    Time frame: 3 year after the index cardiac event

Other outcomes

  1. Smoking status

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

    Time frame: 1 year after the index cardiac event

  2. The Swedish Healthy diet questionnaire

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

    Time frame: 1 year after the index cardiac event

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

    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.

    Time frame: 1 year after the index cardiac event

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

    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'.

    Time frame: 1 year after the index cardiac event

  5. Triglycerides

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

    Time frame: 1 year after the index cardiac event

  6. High-density lipoprotein (HDL) cholesterol

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

    Time frame: 1 year after the index cardiac event

  7. Low-density lipoprotein (LDL) cholesterol

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

    Time frame: 1 year after the index cardiac event

  8. Hemoglobin A1c (HbA1c)

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

    Time frame: 1 year after the index cardiac event

  9. Blood pressure

    mmHg

    Time frame: 1 year after the index cardiac event

  10. Body weight

    kg

    Time frame: 1 year after the index cardiac event

  11. Waist circumference

    cm

    Time frame: 1 year after the index cardiac event

07

Study locations

30 of 35 sites recruiting
  • Alingsås lasarett
    Alingsås, Sweden
    Recruiting
    • Petter Tollemark · Contact
  • Bollnäs sjukhus
    Bollnäs, Sweden
    Recruiting
    • Maria Östman · Contact
  • NU-sjukvården Dalslands sjukhus
    Bäckefors, Sweden
    Recruiting
  • Höglandssjukhuset Eksjö
    Eksjö, Sweden
    Recruiting
    • Helene Warin · Contact
  • Lasarettet Enköping
    Enköping, Sweden
    Recruiting
    • Görel Stengård · Contact
  • Sahlgrenska University Hospital Sahlgrenska
    Gothenburg, Sweden
    Recruiting
  • Gävle sjukhus
    Gävle, Sweden
    Not yet recruiting
    • Anna Cutler · Contact
  • Helsingborgs lasarett
    Helsingborg, Sweden
    Recruiting
    • Bjarne Madsen Härdig · Contact
  • Jönköping Ryhov Hospital
    Jönköping, Sweden
    Recruiting
  • Kalix sjukhus
    Kalix, Sweden
    Recruiting
    • Magdalena Engren Jonsson · Contact
  • Länssjukhuset Kalmar
    Kalmar, Sweden
    Recruiting
    • Charlotta Lans · Contact
  • Centralsjukhuset Karlstad
    Karlstad, Sweden
    Recruiting
    • Karin Arinell · Contact
  • Kullbergska sjukhuset
    Katrineholm, Sweden
    Recruiting
    • Hanna Hafström Eng · Contact
  • Västmanlands sjukhus Köping
    Köping, Sweden
    Recruiting
    • Marianne Ordell Schieman · Contact
  • Universitetssjukhuset Linköping
    Linköping, Sweden
    Recruiting
    • Sabina Borg · Contact
  • Sunderby sjukhus
    Luleå, Sweden
    Recruiting
    • Maarit Kylmamaa · Contact
  • NU-sjukvården Lysekil
    Lysekil, Sweden
    Recruiting
    • Marica Stenström · Contact
  • Skåne Universitetssjukhus Malmö
    Malmö, Sweden
    Recruiting
    • Margret Leosdottir · Contact
  • Vrinnevisjukhuset
    Norrköping, Sweden
    Withdrawn

    Not enrolling at this site — choose another above.

  • Oskarshamns sjukhus
    Oskarshamn, Sweden
    Recruiting
    • Sofi Karlsson · Contact
  • Västmanlands sjukhus Sala
    Sala, Sweden
    Recruiting
    • Marica Hallsten Larsson · Contact
  • Sandvikens sjukhus
    Sandviken, Sweden
    Recruiting
    • Anna Cutler · Contact
  • Capio Närsjukhus Simrishamn
    Simrishamn, Sweden
    Recruiting
    • Pernilla Rosberg Håkansson · Contact
  • Skaraborgs sjukhus Skövde
    Skövde, Sweden
    Recruiting
    • Frida Brevitz · Contact
  • Capio St Göran
    Stockholm, Sweden
    Recruiting
    • Anneli Johansson · Contact
  • Karolinska University Hospital Solna and Huddinge
    Stockholm, Sweden
    Recruiting
  • Södersjukhuset
    Stockholm, Sweden
    Recruiting
    • Robin Hofmann · Contact
  • NU-sjukvården Strömstad
    Strömstad, Sweden
    Recruiting
    • Barbro Limnell · Contact
  • Söderhamns sjukhus
    Söderhamn, Sweden
    Not yet recruiting
    • Anna-Sara Raphael · Contact
  • Norrlands Universitetssjukhus Umeå
    Umeå, Sweden
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Akademiska sjukhuset
    Uppsala, Sweden
    Recruiting
    • Emil Hagström · Contact
  • Hallands sjukhus Varberg
    Varberg, Sweden
    Recruiting
    • Frida Johansson · Contact
  • Visby Lasarett
    Visby, Sweden
    Not yet recruiting
  • Värnamo sjukhus
    Värnamo, Sweden
    Recruiting
    • Monica Cederblad · Contact
  • Västerviks sjukhus
    Västervik, Sweden
    Recruiting
    • Emmy Cheruiyot Johansson · Contact
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2022 (actual). Primary completion is estimated for Apr 2026, 48 months after the start.

Of 296 non-industry observational studies under Myocardial Infarction, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 140. This study's planned 48 months is below that.

Counting every sponsor, half of 333 studies reached it within 48 months; a quarter within 17 and three quarters within 114.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 10, 2022
First posted
Apr 21, 2022
StartActual
Apr 26, 2022
Primary completionEst.
Apr 26, 2026
CompletionEst.
Apr 26, 2029
Last update
Feb 11, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05339477
Responsible party
Maria Bäck (Professor, physiotherapist, Sahlgrenska University Hospital) — Principal investigator
First posted
Apr 21, 2022
Start date
Apr 26, 2022
Primary completion
Apr 26, 2026 (estimated)
Completion
Apr 26, 2029 (estimated)
Last update
Feb 11, 2025

Study contacts

Maria Bäck, PhD
Contact
maria.m.back@vgregion.se
+46313421195
Johanna Lilliecrona, MSc
Contact
johanna.lilliecrona@vgregion.se
+46313421195
Maria Bäck, PhD
principal investigator · Department of physiotherapy, Sahlgrenska University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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