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NCT04450459 Clinical Trial

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

Stable Angina Clinical Trial

— ADVANCE  

Official title:
Impact of Ergospirometric Oxygen Uptake Under Exercise as Diagnostic Marker of Cardiac Ischemia in Patients With Stable Angina Compared to Non Invasive and Invasive (FFR) Measurement of Ischemia

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04450459
Other study ID # SMW 08
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2, 2019
Est. completion date June 2023

Study information
Verified date August 2022
Source Jena University Hospital
Contact Sven Möbius-Winkler, MD
Phone 0049-3641-9324503
Email Sven.Moebius-Winkler@med.uni-jena.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date June 2023
Est. primary completion date January 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• ergospirometer test
ergospirometric test will be done before cardiac catheterisation and invasive measurement of FFR

Locations
Country Name City State
Germany Universityhospital Jena

Sponsors (1)
Lead Sponsor Collaborator
Jena University Hospital

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary double slope sign of ?V?O2/?WR-Increase double slope sign of ?V?O2/?WR by ergospirometer test baseline
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