PRV-based Detection of CAD in Comparison to Standard Methods | NCT02404948

Studies
PRV-based Detection of CAD in Comparison to Standard Methods

NCT02404948

Sponsor

University Medicine Greifswald

Status

Completed

Last Update Posted

Jul 3, 2018Actual

Enrollment

156Actual

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

Diagnostic algorithm

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Jul 2016Actual

Completion Date

Jun 2017Actual

First Submitted Date

Mar 23, 2015

First Submission Date that Met QC Criteria

Mar 26, 2015

First Posted Date

Apr 1, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2018

Last Update Posted Date

Jul 3, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The study will validate a pulse wave based algorithm for the detection of coronary artery disease (CAD) with parameters from standard methods. Subjects will be patients admitted to coronary angiography due to suspected CAD. Pulse wave signals will be analyzed according to novelly established algorithm regarding the presence of CAD and/or myocardial ischemia. These results be compared to the diagnoses made by coronary angiography (primary endpoint): presence of minimum one coronary artery stenose >=50%. For secondary analyses, results will be compared to parameters form echocardiography and cardiogoniometry.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

156Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diagnostic algorithm	Other	Validation of a diagnostic algorithm used to detect coronary artery disease and/or myocardial ischemia based on pulse wave analyses.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence of CAD - angio (minimum 1 stenosis >=50%)	Presence of CAD in coronary angiography: minimum 1 stenosis >=50%	1 day

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Coronary angiography indication present
informed written consent

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Subjects referred to first coronary angiography due to suspected CAD

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Marcus Dörr		Greifswald		17475	Germany

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease
D004194	Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided