The Physical Activity Post Myocardial Infarction SWEDEHEART Prospective Cohort Study

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Infarction
• Intervention / Treatment: Other: Accelerometer measurement

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.

• Study Type: Observational
• Enrollment (Estimated): 4000

Contacts and Locations

• Study Contact: Name: Maria Bäck, PhD; Phone Number: +46313421195; Email: maria.m.back@vgregion.se
• Study Contact Backup: Name: Johanna Lilliecrona, MSc; Phone Number: +46313421195; Email: johanna.lilliecrona@vgregion.se

Study Locations

• Sweden
  • Alingsås, Sweden
    • Recruiting
    • Alingsas Lasarett
    • Contact: Petter Tollemark
  • Bollnäs, Sweden
    • Not yet recruiting
    • Bollnäs sjukhus
    • Contact: Maria Östman
  • Eksjö, Sweden
    • Recruiting
    • Höglandssjukhuset Eksjö
    • Contact: Helene Warin
  • Enköping, Sweden
    • Not yet recruiting
    • Lasarettet Enköping
    • Contact: Görel Stengård
  • Gothenburg, Sweden
    • Recruiting
    • Sahlgrenska University Hospital Sahlgrenska
    • Contact: Maria Lachonius, RN; Email: maria.lachonius@vgregion.se
  • Gävle, Sweden
    • Not yet recruiting
    • Gävle Sjukhus
    • Contact: Anna Cutler
  • Helsingborg, Sweden
    • Recruiting
    • Helsingborgs lasarett
    • Contact: Bjarne Madsen Härdig
  • Jönköping, Sweden
    • Recruiting
    • Jönköping Ryhov Hospital
    • Contact: Emma Hag, RN; Email: emma.hag@rjl.se
  • Kalix, Sweden
    • Recruiting
    • Kalix sjukhus
    • Contact: Magdalena Engren Jonsson
  • Kalmar, Sweden
    • Recruiting
    • Länssjukhuset Kalmar
    • Contact: Charlotta Lans
  • Karlstad, Sweden
    • Not yet recruiting
    • Centralsjukhuset Karlstad
    • Contact: Karin Arinell
  • Katrineholm, Sweden
    • Recruiting
    • Kullbergska sjukhuset
    • Contact: Hanna Hafström Eng
  • Köping, Sweden
    • Recruiting
    • Västmanlands sjukhus Köping
    • Contact: Marianne Ordell Schieman
  • Linköping, Sweden
    • Not yet recruiting
    • Universitetssjukhuset Linköping
    • Contact: Sabina Borg
  • Luleå, Sweden
    • Not yet recruiting
    • Sunderby Sjukhus
    • Contact: Maarit Kylmamaa
  • Lysekil, Sweden
    • Recruiting
    • NU-sjukvården Lysekil
    • Contact: Marica Stenström
  • Malmö, Sweden
    • Recruiting
    • Skåne Universitetssjukhus Malmö
    • Contact: Margret Leosdottir
  • Norrköping, Sweden
    • Not yet recruiting
    • Vrinnevisjukhuset
    • Contact: Sanna Lindgren
  • Oskarshamn, Sweden
    • Recruiting
    • Oskarshamns sjukhus
    • Contact: Sofi Karlsson
  • Sala, Sweden
    • Recruiting
    • Västmanlands sjukhus Sala
    • Contact: Marica Hallsten Larsson
  • Sandviken, Sweden
    • Not yet recruiting
    • Sandvikens sjukhus
    • Contact: Anna Cutler
  • Simrishamn, Sweden
    • Not yet recruiting
    • Capio Närsjukhus Simrishamn
    • Contact: Pernilla Rosberg Håkansson
  • Skövde, Sweden
    • Not yet recruiting
    • Skaraborgs sjukhus Skövde
    • Contact: Frida Brevitz
  • Stockholm, Sweden
    • Recruiting
    • Sodersjukhuset
    • Contact: Robin Hofmann
  • Stockholm, Sweden
    • Recruiting
    • Karolinska University Hospital Solna and Huddinge
    • Contact: Matthias Lidin, PhD; Email: matthias.lidin@ki.se
  • Stockholm, Sweden
    • Not yet recruiting
    • Capio St Göran
    • Contact: Anneli Johansson
  • Strömstad, Sweden
    • Recruiting
    • NU-sjukvården Strömstad
    • Contact: Barbro Limnell
  • Söderhamn, Sweden
    • Not yet recruiting
    • Söderhamns sjukhus
    • Contact: Anna-Sara Raphael
  • Umeå, Sweden
    • Recruiting
    • Norrlands Universitetssjukhus Umeå
    • Contact: Camilla Sandberg
  • Uppsala, Sweden
    • Recruiting
    • Akademiska Sjukhuset
    • Contact: Emil Hagström
  • Varberg, Sweden
    • Not yet recruiting
    • Hallands Sjukhus Varberg
    • Contact: Frida Johansson
  • Värnamo, Sweden
    • Recruiting
    • Värnamo sjukhus
    • Contact: Monica Cederblad
  • Västervik, Sweden
    • Recruiting
    • Västerviks sjukhus
    • Contact: Emmy Cheruiyot Johansson

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Other: Accelerometer 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular mortality	Incidence of cardiovascular mortality	1 year after the index cardiac event
Non-fatal myocardial infarction	Incidence of non-fatal myocardial infarction	1 year after the index cardiac event
Non-fatal ischemic stroke	Incidence of non-fatal ischemic stroke	1 year after the index cardiac event
Coronary revascularization	Incidence of coronary revascularization	1 year after the index cardiac event
Heart failure	Incidence of hospitalization for new or worsening heart failure	1 year after the index cardiac event
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	3 years after the index cardiac event
Cardiovascular mortality	Incidence of cardiovascular mortality	3 years after the index cardiac event
Non-fatal myocardial infarction	Incidence of non-fatal myocardial infarction	3 years after the index cardiac event
Non-fatal ischemic stroke	Incidence of non-fatal ischemic stroke	3 years after the index cardiac event
Coronary revascularization	Incidence of coronary revascularization	3 years after the index cardiac event
Heart failure	Incidence of hospitalization for new or worsening heart failure	3 years after the index cardiac event
All-cause death	Incidence of all-cause death	1 year after the index cardiac event
All-cause death	Incidence of all-cause death	3 year after the index cardiac event

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking status	0=Never smoker, 1=Former smoker > 1 month, 2=Smoker	1 year after the index cardiac event
The Swedish Healthy diet questionnaire	Four questions with Likert scale 0-3 points. Higher scores indicate better outcomes	1 year after the index cardiac event
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.	1 year after the index cardiac event
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'.	1 year after the index cardiac event
Triglycerides	Plasma levels of triglycerides (mmol/L). Higher values indicate worse outcome.	1 year after the index cardiac event
High-density lipoprotein (HDL) cholesterol	Plasma levels of HDL (mmol/L). Higher values indicate better outcome	1 year after the index cardiac event
Low-density lipoprotein (LDL) cholesterol	Plasma levels of LDL cholesterol (mmol/L). Higher values indicate worse outcome	1 year after the index cardiac event
Hemoglobin A1c (HbA1c)	HbA1c (mmol/L). Measures the amount of blood sugar. Higher values indicate worse outcome	1 year after the index cardiac event
Blood pressure	mmHg	1 year after the index cardiac event
Body weight	kg	1 year after the index cardiac event
Waist circumference	cm	1 year after the index cardiac event

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden
• Collaborators: Gothia Forum - Center for Clinical Trial
• Investigators: Principal Investigator: Maria Bäck, PhD, Department of physiotherapy, Sahlgrenska University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2022
• Primary Completion (Estimated): April 26, 2024
• Study Completion (Estimated): April 26, 2027

Study Registration Dates

• First Submitted: April 10, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: physical activity; Registry; Accelerometer
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: 277371

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No