NCT02404948

Brief Summary

This is a validation study comparing a pulse wave based algorithm for the detection of coronary artery disease with parameters from coronary angiography, echocardiography and cardiogoniometry.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2015

Typical duration 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

First Submitted

Initial submission to the registry

March 23, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 3, 2018

Status Verified

June 1, 2018

Enrollment Period

1.3 years

First QC Date

March 23, 2015

Last Update Submit

June 29, 2018

Conditions

Coronary Artery Disease

Keywords

coronary artery diseasediagnosisnon-invasive

Outcome Measures

Primary Outcomes (1)

  • Presence of CAD - angio (minimum 1 stenosis >=50%)

    Presence of CAD in coronary angiography: minimum 1 stenosis \>=50%

    1 day

Secondary Outcomes (5)

  • Presence of CAD number - angio (Number of coronary vessels with at least 1 stenosis >=50% in coronary angiography)

    1 day

  • Wall motion abnormality - echo (Presence of wall motion abnormality in at least 1 segment (2D echocardiography)

    1 day

  • Wall motion index - echo (Wall motion index (2D and 3D echocardiography)

    1 day

  • Global longitudinal strain (2D and 3D echocardiography)

    1 day

  • Abnormal cardiogoniometry

    1 day

Interventions

Diagnostic algorithmOTHER

Validation of a diagnostic algorithm used to detect coronary artery disease and/or myocardial ischemia based on pulse wave analyses.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects referred to first coronary angiography due to suspected CAD

You may qualify if:

  • Coronary angiography indication present
  • informed written consent

You may not qualify if:

  • Previous coronary angiography
  • Known CAD (history of coronary angioplasty, stent implantation and/or bypass surgery)
  • atrial fibrillation (at time of measurement)
  • severe ventricular extrasystole (e.g. \>=10% ventricular extrasystoles, bigemina)
  • pregnancy, lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marcus Dörr

Greifswald, 17475, Germany

Location

MeSH Terms

Conditions

Coronary Artery DiseaseDisease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

March 23, 2015

First Posted

April 1, 2015

Study Start

April 1, 2015

Primary Completion

July 1, 2016

Study Completion

June 1, 2017

Last Updated

July 3, 2018

Record last verified: 2018-06

Locations

DE(1)