NCT02382926

Brief Summary

In this trial contactless heart rate, electrocardiography and breathing rate measurements are elevated during car simulation in cardiac rehabilitation via automotive sensors and camera.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

October 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 9, 2015

Completed
Last Updated

March 13, 2015

Status Verified

March 1, 2015

Enrollment Period

1 month

First QC Date

March 3, 2015

Last Update Submit

March 12, 2015

Conditions

Cardiac Events

Keywords

capacitive electrocardiographyEulerian Magnification Method

Outcome Measures

Primary Outcomes (1)

  • arrhythmia

    feasibility of cECG data for example as arrhythmia, tachycardia in comparison to long term ECG data

    30 minutes

Secondary Outcomes (1)

  • Heart rate via contactless camera

    30 minutes

Other Outcomes (1)

  • Breathing rate via contactless camera

    30 minutes

Study Arms (1)

contactless heart-, breathing rate, ECG

EXPERIMENTAL
Other: Capacitive ECG and contactless heart and breathing rate measurements via camera

Interventions

Capacitive ECG and contactless heart and breathing rate measurements via cameraOTHER

During a 30 minute driving simulation cardiologic patients in rehabilitation undergo capacitive ECG measurements via sensors in the car seat as well as heart and breathing rate measurements via camera according to the Eulerian Magnification Method.

contactless heart-, breathing rate, ECG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • cardiologic diseases after acute event (e. g. myocard infarction, bypass surgery)
  • rehabilitation in clinic "An der Rosenquelle"

You may not qualify if:

  • dementia
  • lack of language ability
  • pregnancy
  • implanted electric devices (as e.g. heart pacemaker, inverted cardiodefibrillator)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinic of Rehabilitation "An der Rosenquelle", Kurbrunnenstreet 5

Aachen, North Rhine-Westphalia, 52064, Germany

Location

University Hospital Aachen, Department of Cardiology, Angiology, Pneumology and Intensive Medicine

Aachen, North Rhine-Westphalia, 52074, Germany

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Sebastian Reith, MD

    University Hospital Aachen, Clinic of Cardiology, Angiology, Pneumology and Intensive Care Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2015

First Posted

March 9, 2015

Study Start

October 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

March 13, 2015

Record last verified: 2015-03

Locations

DE(2)