Impact of Spiroergometer Parameters as Diagnostic Marker... | NCT04450459

Studies
Impact of Spiroergometer Parameters as Diagnostic Marker of Cardiac Ischemia in Pts. With Stable Angina Compared to FFR.

NCT04450459

Sponsor

Jena University Hospital

Status

Unknown status

Last Update Posted

Aug 11, 2022Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Stable Angina

Interventions

ergospirometer test

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

Aug 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2, 2019Actual

Primary Completion Date

Jan 2023Estimated

Completion Date

Jun 2023Estimated

First Submitted Date

Jun 25, 2020

First Submission Date that Met QC Criteria

Jun 25, 2020

First Posted Date

Jun 29, 2020Actual

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

Aug 10, 2022

Last Update Posted Date

Aug 11, 2022Actual

Description Module

Brief Summary

In Patients with stable Angina pectoris CCS 1-3 exercise testing for ischemia detection is widely used despite the known limitations. Measurement of the FFR is invasive but gold standard for Ischemia detection.

Adding of parameters of spiroergometer might help to improve diagnostic accuracy of non invasive exercise testing. Therefore the trial is evaluating diagnostic accuracy of spiroergometric parameters compared to invasive FFR measurement.

Detailed Description

Not provided

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

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ergospirometer test	Diagnostic Test	ergospirometric test will be done before cardiac catheterisation and invasive measurement of FFR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
double slope sign of ΔV̇O2/ΔWR-Increase	double slope sign of ΔV̇O2/ΔWR by ergospirometer test	baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

stable Angina (CCS >1-3) with suspected CAD or
dyspnoea at exertion NYHA >2 or
signs of ischemia within SPECT or exercise electrocardiography
willingness to participate in the trial

Exclusion Criteria:

Unstable angina or myocardial infarction within the last 2 weeks
inability to perform bicycle exercise test
significant valvular disease
HOCM
av- block >I degree
asthma bronchiales

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with suspected CAD presenting for diagnostic testing/ coronary angiography

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sven Möbius-Winkler, MD	Contact	0049-3641-9324503		Sven.Moebius-Winkler@med.uni-jena.de
Sissy Grund	Contact			sissy.grun@med.uni-jena.de

Overall Officials

Name	Affiliation	Role
Sven Möbius-Winkler, MD	Universityhospital Jena	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universityhospital	Recruiting	Jena		07747	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D060050	Angina, Stable

Ancestor Terms

ID	Term
D000787	Angina Pectoris
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided