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

• Sponsor: Jena University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04450459
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 52.9
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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	Phase
Stable Angina	Diagnostic Test: ergospirometer test

Study Design

• Study Type: Observational
• Anticipated 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: Jan 2, 2019
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Outcome Measures

Primary Outcome Measures

1. double slope sign of ΔV̇O2/ΔWR-Increase [baseline]

   double slope sign of ΔV̇O2/ΔWR by ergospirometer test

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universityhospital	Jena		Germany	07747

Sponsors and Collaborators

• Jena University Hospital

Investigators

• Principal Investigator: Sven Möbius-Winkler, MD, Universityhospital Jena

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jena University Hospital
• ClinicalTrials.gov Identifier: NCT04450459
• Other Study ID Numbers: SMW 08
• First Posted: Jun 29, 2020
• Last Update Posted: Aug 11, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Jena University Hospital: FFR Measurement; exercise testing, ergospirometer
• Additional relevant MeSH terms: Angina Pectoris; Angina, Stable; Coronary Artery Disease; Myocardial Ischemia; Ischemia

Study Results

No Results Posted as of Aug 11, 2022