Stable AnginaADVANCENCT04450459
Impact of Spiroergometer Parameters as Diagnostic Marker of Cardiac Ischemia in Pts. With Stable Angina Compared to FFR.
An observational study of Stable Angina, run by Jena University Hospital at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Angina
- What is being tested?
- ergospirometer test
- How many people
- 121 participants
- Where
- 1 siteGermany
- Study dates
- 2 Jan 2019to 25 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: patients with suspected CAD presenting for diagnostic testing/ coronary angiography
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Stable Angina
- Being tested
- ergospirometer test
- Keywords
- FFR Measurement; exercise testing, ergospirometer
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ergospirometer testDiagnostic test
ergospirometric test will be done before cardiac catheterisation and invasive measurement of FFR
What is being measured
The primary outcome is the main question the study is designed to answer.
double slope sign of ΔV̇O2/ΔWR-Increase
double slope sign of ΔV̇O2/ΔWR by ergospirometer test
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start2 Jan 2019
- Primary completion25 Aug 2025
- Study completion25 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sven Möbius-Winkler, MD, Principal investigator, Universityhospital Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450459
- Sponsor's protocol ID
- SMW 08
- Acronym
- ADVANCE
- Status last verified
- Aug 2025
- First submitted
- 25 Jun 2020
- Last updated
- 6 Aug 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04450459
- Acronym / sponsor ID
- ADVANCE / SMW 08
- Conditions
- Stable Angina
- Keywords
- FFR Measurement; exercise testing, ergospirometer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 25 Aug 2025 (actual)
- Study completion
- 25 Aug 2025 (actual)
- First posted
- 29 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with suspected CAD presenting for diagnostic testing/ coronary angiography
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Unstable angina or myocardial infarction within the last 2 weeks
- inability to perform bicycle exercise test
- significant valvular disease
- HOCM
- av- block >I degree
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ergospirometer testergospirometric test will be done before cardiac catheterisation and invasive measurement of FFR | Diagnostic test | – |
Primary outcome
double slope sign of ΔV̇O2/ΔWR-Increase
Time frame: baseline
double slope sign of ΔV̇O2/ΔWR by ergospirometer test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sven Möbius-Winkler, MD principal investigator
Universityhospital Jena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stable Angina, run by Jena University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
double slope sign of ΔV̇O2/ΔWR-Increase (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.