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

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ClinicalTrials.gov Identifier: NCT04450459
Recruitment Status : Recruiting
First Posted : June 29, 2020
Last Update Posted : August 6, 2020
Sponsor:
Information provided by (Responsible Party):
Jena University Hospital

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.


Condition or disease Intervention/treatment
Stable Angina Diagnostic Test: ergospirometer test

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : January 2, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina


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


Primary Outcome Measures :
  1. double slope sign of ΔV̇O2/ΔWR-Increase [ Time Frame: baseline ]
    double slope sign of ΔV̇O2/ΔWR by ergospirometer test


Biospecimen Retention:   Samples Without DNA
EDTA Blood, Serum,


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
patients with suspected CAD presenting for diagnostic testing/ coronary angiography
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04450459


Contacts
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Contact: Sven Möbius-Winkler, MD 0049-3641-9324503 Sven.Moebius-Winkler@med.uni-jena.de
Contact: Sissy Grund sissy.grun@med.uni-jena.de

Locations
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Germany
Universityhospital Recruiting
Jena, Germany, 07747
Contact: Sven Möbius-Winkler       Sven.Moebius-Winkler@med.uni-jena.de   
Contact: Sissy Grund       sissy.grund@med.uni-jena.de   
Sub-Investigator: Nedim Memisevic, MD         
Sub-Investigator: David Hanke, MD         
Sub-Investigator: Ulf Teichgräber, MD         
Sponsors and Collaborators
Jena University Hospital
Investigators
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Principal Investigator: Sven Möbius-Winkler, MD Universityhospital Jena
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Responsible Party: Jena University Hospital
ClinicalTrials.gov Identifier: NCT04450459    
Other Study ID Numbers: SMW 08
First Posted: June 29, 2020    Key Record Dates
Last Update Posted: August 6, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jena University Hospital:
FFR Measurement; exercise testing, ergospirometer
Additional relevant MeSH terms:
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Coronary Artery Disease
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases
Angina Pectoris
Angina, Stable
Myocardial Ischemia
Ischemia
Pathologic Processes
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Arteriosclerosis