NCT04450459

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 29, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

August 11, 2022

Status Verified

August 1, 2022

Enrollment Period

4 years

First QC Date

June 25, 2020

Last Update Submit

August 10, 2022

Conditions

Stable Angina

Keywords

FFR Measurement; exercise testing, ergospirometer

Outcome Measures

Primary Outcomes (1)

  • double slope sign of ΔV̇O2/ΔWR-Increase

    double slope sign of ΔV̇O2/ΔWR by ergospirometer test

    baseline

Interventions

ergospirometer testDIAGNOSTIC_TEST

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with suspected CAD presenting for diagnostic testing/ coronary angiography

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universityhospital

Jena, 07747, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

EDTA Blood, Serum,

MeSH Terms

Conditions

Angina, Stable

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sven Möbius-Winkler, MD

    Universityhospital Jena

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sven Möbius-Winkler, MD

CONTACT

0049-3641-9324503Sven.Moebius-Winkler@med.uni-jena.de

Sissy Grund

CONTACT

sissy.grun@med.uni-jena.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2020

First Posted

June 29, 2020

Study Start

January 2, 2019

Primary Completion

January 1, 2023

Study Completion

June 1, 2023

Last Updated

August 11, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)