NCT05771610

Brief Summary

Cardiovascular Disease (CVD) is the leading cause of mortality and morbidity globally. Following a myocardial infarction (MI), an individual is at an increased risk of a secondary event (20-50% higher risk post MI), compared to those with no prior CVD. Independent of physical activity levels, high amounts of daily sitting is a risk factor for CVD, of which sitting is typically used as an indicator for sedentary behaviour. Sedentary behaviour is defined as a waking energy expenditure of less than 1.5 METs (metabolic task equivalent) while in a seated, reclined or lying posture. Currently, there is little knowledge regarding the prevalence of sedentary behaviour ischaemic heart disease. The aim of this study is therefore to measure activity levels of an individual following a diagnosis of ischaemic heart disease, alongside its association to cardiac function and cardiovascular risk factors. Sitting patterns and physical activity will be monitored 24 h/day during each condition using an activPAL activity monitor (PAL Technologies, Glasco, Scotland). This will measure changes in posture and level of activity by cadence.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

March 2, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

March 6, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 16, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

9 months

First QC Date

March 2, 2023

Last Update Submit

March 14, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Daily sitting time in IHD

    Measured using activpal

    7 days

Secondary Outcomes (20)

  • Posterior wall thickness

    9 months

  • Intraventricular septum

    9 months

  • Left ventricular internal diameter

    9 months

  • Aortic root

    9 months

  • End volume

    9 months

  • +15 more secondary outcomes

Interventions

Only individuals who have had a cardiac event within the past twelve months upon recruitment will be included in this study.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ischaemic heart disease, including a myocardial infarction within the past twelve months ((NSTEMI or STEMI) confirmed by blood markers or electrophysiological changes); or angina treated with PCI or CABG.

You may qualify if:

  • · Patients diagnosed with ischemic heart disease within the past 12 months (within National Audit of Cardiac Rehabilitation (NACR) outcome data). This includes post myocardial infarction (ST wave elevated MI or Non-ST wave elevated MI), post coronary artery bypass graft, post percutaneous coronary intervention.
  • Males and females
  • Aged 18 years or above.
  • Any ethnicity.

You may not qualify if:

  • · Under 18 years of age.
  • Unable to provide valid informed consent (lack of mental capacity).
  • Not had a cardiac event diagnosed within the past 12 months.
  • Unstable coronary disease.
  • Disease or conditions with a prognosis of less than 6 months to end of life (palliative care).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiovascular DiseasesSedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 2, 2023

First Posted

March 16, 2023

Study Start

March 6, 2023

Primary Completion

December 1, 2023

Study Completion

December 31, 2023

Last Updated

March 16, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share