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OpenTrials
Completed

NCT Number: NCT04450459

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universityhospital

Jena, 07747, Germany

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ergospirometer test

Diagnostic Test

ergospirometric test will be done before cardiac catheterisation and invasive measurement of FFR

Primary outcomes

  1. double slope sign of ΔV̇O2/ΔWR-Increase

    Time frame: baseline

    double slope sign of ΔV̇O2/ΔWR by ergospirometer test

Sponsors and collaborators

Lead sponsor

Jena University Hospital

Other

Registry information

Official study 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

Acronym: ADVANCE

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jun 29, 2020
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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