The Physical Activity Post Myocardial Infarction SWEDEHEART Prospective Cohort Study

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05339477
• Other study ID #: 277371
• Status: Recruiting
• Start date: April 26, 2022
• Est. completion date: April 26, 2027

Study information

• Verified date: December 2023
• Source: Sahlgrenska University Hospital, Sweden
• Contact: Maria Bäck, PhD
• Phone: +46313421195
• Email: maria.m.back[@]vgregion.se
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: April 26, 2027
• Est. primary completion date: April 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

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.

Locations

Country	Name	City	State
Sweden	Alingsås lasarett	Alingsås
Sweden	Bollnäs sjukhus	Bollnäs
Sweden	Höglandssjukhuset Eksjö	Eksjö
Sweden	Lasarettet Enköping	Enköping
Sweden	Gävle sjukhus	Gävle
Sweden	Sahlgrenska University Hospital Sahlgrenska	Gothenburg
Sweden	Helsingborgs lasarett	Helsingborg
Sweden	Jönköping Ryhov Hospital	Jönköping
Sweden	Kalix sjukhus	Kalix
Sweden	Länssjukhuset Kalmar	Kalmar
Sweden	Centralsjukhuset Karlstad	Karlstad
Sweden	Kullbergska sjukhuset	Katrineholm
Sweden	Västmanlands sjukhus Köping	Köping
Sweden	Universitetssjukhuset Linköping	Linköping
Sweden	Sunderby sjukhus	Luleå
Sweden	NU-sjukvården Lysekil	Lysekil
Sweden	Skåne Universitetssjukhus Malmö	Malmö
Sweden	Vrinnevisjukhuset	Norrköping
Sweden	Oskarshamns sjukhus	Oskarshamn
Sweden	Västmanlands sjukhus Sala	Sala
Sweden	Sandvikens sjukhus	Sandviken
Sweden	Capio Närsjukhus Simrishamn	Simrishamn
Sweden	Skaraborgs sjukhus Skövde	Skövde
Sweden	Söderhamns sjukhus	Söderhamn
Sweden	Capio St Göran	Stockholm
Sweden	Karolinska University Hospital Solna and Huddinge	Stockholm
Sweden	Södersjukhuset	Stockholm
Sweden	NU-sjukvården Strömstad	Strömstad
Sweden	Norrlands Universitetssjukhus Umeå	Umeå
Sweden	Akademiska sjukhuset	Uppsala
Sweden	Hallands sjukhus Varberg	Varberg
Sweden	Värnamo sjukhus	Värnamo
Sweden	Västerviks sjukhus	Västervik

Sponsors (2)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden	Gothia Forum - Center for Clinical Trial

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Smoking status	0=Never smoker, 1=Former smoker > 1 month, 2=Smoker	1 year after the index cardiac event
Other	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
Other	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
Other	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
Other	Triglycerides	Plasma levels of triglycerides (mmol/L). Higher values indicate worse outcome.	1 year after the index cardiac event
Other	High-density lipoprotein (HDL) cholesterol	Plasma levels of HDL (mmol/L). Higher values indicate better outcome	1 year after the index cardiac event
Other	Low-density lipoprotein (LDL) cholesterol	Plasma levels of LDL cholesterol (mmol/L). Higher values indicate worse outcome	1 year after the index cardiac event
Other	Hemoglobin A1c (HbA1c)	HbA1c (mmol/L). Measures the amount of blood sugar. Higher values indicate worse outcome	1 year after the index cardiac event
Other	Blood pressure	mmHg	1 year after the index cardiac event
Other	Body weight	kg	1 year after the index cardiac event
Other	Waist circumference	cm	1 year after the index cardiac event
Primary	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	Cardiovascular mortality	Incidence of cardiovascular mortality	1 year after the index cardiac event
Secondary	Non-fatal myocardial infarction	Incidence of non-fatal myocardial infarction	1 year after the index cardiac event
Secondary	Non-fatal ischemic stroke	Incidence of non-fatal ischemic stroke	1 year after the index cardiac event
Secondary	Coronary revascularization	Incidence of coronary revascularization	1 year after the index cardiac event
Secondary	Heart failure	Incidence of hospitalization for new or worsening heart failure	1 year after the index cardiac event
Secondary	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
Secondary	Cardiovascular mortality	Incidence of cardiovascular mortality	3 years after the index cardiac event
Secondary	Non-fatal myocardial infarction	Incidence of non-fatal myocardial infarction	3 years after the index cardiac event
Secondary	Non-fatal ischemic stroke	Incidence of non-fatal ischemic stroke	3 years after the index cardiac event
Secondary	Coronary revascularization	Incidence of coronary revascularization	3 years after the index cardiac event
Secondary	Heart failure	Incidence of hospitalization for new or worsening heart failure	3 years after the index cardiac event
Secondary	All-cause death	Incidence of all-cause death	1 year after the index cardiac event
Secondary	All-cause death	Incidence of all-cause death	3 year after the index cardiac event