NCT05339477

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
35mo left

Started Apr 2022

Longer than P75 for all trials

Geographic Reach
1 country

35 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Apr 2022Apr 2029

First Submitted

Initial submission to the registry

April 10, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

April 26, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2026

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2029

Expected
Last Updated

February 11, 2025

Status Verified

February 1, 2025

Enrollment Period

4 years

First QC Date

April 10, 2022

Last Update Submit

February 9, 2025

Conditions

Keywords

physical activityAccelerometerRegistry

Outcome Measures

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

    1 year after the index cardiac event

Secondary Outcomes (13)

  • Cardiovascular mortality

    1 year after the index cardiac event

  • Non-fatal myocardial infarction

    1 year after the index cardiac event

  • Non-fatal ischemic stroke

    1 year after the index cardiac event

  • Coronary revascularization

    1 year after the index cardiac event

  • Heart failure

    1 year after the index cardiac event

  • +8 more secondary outcomes

Other Outcomes (11)

  • Smoking status

    1 year after the index cardiac event

  • The Swedish Healthy diet questionnaire

    1 year after the index cardiac event

  • Health-related quality of life (EuroQol- 5 Dimension)

    1 year after the index cardiac event

  • +8 more other outcomes

Study Arms (1)

Cohort group

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

Other: Accelerometer measurement

Interventions

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.

Cohort group

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (35)

Alingsås lasarett

Alingsås, Sweden

RECRUITING

NU-sjukvården Dalslands sjukhus

Bäckefors, Sweden

RECRUITING

Bollnäs sjukhus

Bollnäs, Sweden

RECRUITING

Höglandssjukhuset Eksjö

Eksjö, Sweden

RECRUITING

Lasarettet Enköping

Enköping, Sweden

RECRUITING

Gävle sjukhus

Gävle, Sweden

NOT YET RECRUITING

Sahlgrenska University Hospital Sahlgrenska

Gothenburg, Sweden

RECRUITING

Helsingborgs lasarett

Helsingborg, Sweden

RECRUITING

Jönköping Ryhov Hospital

Jönköping, Sweden

RECRUITING

Kalix sjukhus

Kalix, Sweden

RECRUITING

Länssjukhuset Kalmar

Kalmar, Sweden

RECRUITING

Centralsjukhuset Karlstad

Karlstad, Sweden

RECRUITING

Kullbergska sjukhuset

Katrineholm, Sweden

RECRUITING

Västmanlands sjukhus Köping

Köping, Sweden

RECRUITING

Universitetssjukhuset Linköping

Linköping, Sweden

RECRUITING

Sunderby sjukhus

Luleå, Sweden

RECRUITING

NU-sjukvården Lysekil

Lysekil, Sweden

RECRUITING

Skåne Universitetssjukhus Malmö

Malmo, Sweden

RECRUITING

Vrinnevisjukhuset

Norrköping, Sweden

WITHDRAWN

Oskarshamns sjukhus

Oskarshamn, Sweden

RECRUITING

Västmanlands sjukhus Sala

Sala, Sweden

RECRUITING

Sandvikens sjukhus

Sandviken, Sweden

RECRUITING

Capio Närsjukhus Simrishamn

Simrishamn, Sweden

RECRUITING

Skaraborgs sjukhus Skövde

Skövde, Sweden

RECRUITING

Söderhamns sjukhus

Söderhamn, Sweden

NOT YET RECRUITING

Capio St Göran

Stockholm, Sweden

RECRUITING

Karolinska University Hospital Solna and Huddinge

Stockholm, Sweden

RECRUITING

Södersjukhuset

Stockholm, Sweden

RECRUITING

NU-sjukvården Strömstad

Strömstad, Sweden

RECRUITING

Norrlands Universitetssjukhus Umeå

Umeå, Sweden

ACTIVE NOT RECRUITING

Akademiska sjukhuset

Uppsala, Sweden

RECRUITING

Hallands sjukhus Varberg

Varberg, Sweden

RECRUITING

Värnamo sjukhus

Värnamo, Sweden

RECRUITING

Västerviks sjukhus

Västervik, Sweden

RECRUITING

Visby Lasarett

Visby, Sweden

NOT YET RECRUITING

MeSH Terms

Conditions

Myocardial InfarctionMotor Activity

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisBehavior

Study Officials

  • Maria Bäck, PhD

    Department of physiotherapy, Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Johanna Lilliecrona, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, physiotherapist

Study Record Dates

First Submitted

April 10, 2022

First Posted

April 21, 2022

Study Start

April 26, 2022

Primary Completion

April 26, 2026

Study Completion (Estimated)

April 26, 2029

Last Updated

February 11, 2025

Record last verified: 2025-02

Locations