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

NCT ID: NCT04450459

Last Updated: 2022-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-02

Study Completion Date

2023-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Stable Angina

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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ergospirometer test

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jena University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sven Möbius-Winkler, MD

Role: PRINCIPAL_INVESTIGATOR

Universityhospital Jena

Locations

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Universityhospital

Jena, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Sven Möbius-Winkler, MD

Role: CONTACT

0049-3641-9324503

Sissy Grund

Role: CONTACT

Facility Contacts

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Sven Möbius-Winkler

Role: primary

Sissy Grund

Role: backup

Other Identifiers

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SMW 08

Identifier Type: -

Identifier Source: org_study_id

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