NCT04290091

Brief Summary

This study aims to validate the sensor data of gyroscope and accelerometer in detection of hemodynamically significant CAD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
930

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 29, 2020

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

1.9 years

First QC Date

February 25, 2020

Last Update Submit

July 9, 2025

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Coronary artery disease

    CCTA results with optional myocardial PET perfusion imaging

    Time of enrolment

Secondary Outcomes (2)

  • Coronary artery disease event

    1 year after enrolment to the study

  • Coronary artery disease event

    2 year after enrolment to the study

Study Arms (2)

Patients with CAD

Patients who have hemodynamically significant CAD.

Patients without CAD

Patients who don't have hemodynamically significant CAD.

Eligibility Criteria

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

Study includes patients who are referred to a CCTA imaging in Turku University hospital, Turku, Finland due to suspected CAD.

You may qualify if:

  • Age \> 18 years
  • Patients visiting hospital for suspected CAD and undergoing CCTA
  • Signed informed consent as an acceptance to participate to the trial

You may not qualify if:

  • informed consent not signed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, 20520, Finland

Location

Related Publications (1)

  • Haddad F, Saraste A, Santalahti KM, Pankaala M, Kaisti M, Kandolin R, Simonen P, Nammas W, Jafarian Dehkordi K, Koivisto T, Knuuti J, Mahaffey KW, Blomster JI. Smartphone-Based Recognition of Heart Failure by Means of Microelectromechanical Sensors. JACC Heart Fail. 2024 Jun;12(6):1030-1040. doi: 10.1016/j.jchf.2024.01.022. Epub 2024 Apr 3.

    PMID: 38573263DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Juhani Knuuti, MD, PhD

    Turku University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2020

First Posted

February 28, 2020

Study Start

January 29, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2023

Last Updated

July 14, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)