Clinical Trials Logo
  1. Home
  2. Stable Angina
  3. NCT04450459
  4. Details
NCT04450459 Clinical Trial

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

Stable Angina Clinical Trial

— ADVANCE  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04450459
Other study ID # SMW 08
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2, 2019
Est. completion date June 2023

Study information
Verified date August 2022
Source Jena University Hospital
Contact Sven Möbius-Winkler, MD
Phone 0049-3641-9324503
Email Sven.Moebius-Winkler@med.uni-jena.de
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date June 2023
Est. primary completion date January 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Germany Universityhospital Jena

Sponsors (1)
Lead Sponsor Collaborator
Jena University Hospital

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary double slope sign of ?V?O2/?WR-Increase double slope sign of ?V?O2/?WR by ergospirometer test baseline
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02892903 - In the Management of Coronary Artery Disease, Does Routine Pressure Wire Assessment at the Time of Coronary Angiography Affect Management Strategy, Hospital Costs and Outcomes? N/A
Not yet recruiting NCT02871622 - BMX Alpha Registry: a Post-market Registry of the BioMatrix Alpha TM N/A
Not yet recruiting NCT02550301 - Does Mean Platelet Volume Change With Clopidogrel N/A
Completed NCT02252406 - Impact of Ranolazine in Blood Markers in Women With Angina and Metabolic Syndrome Phase 4
Active, not recruiting NCT02244853 - Heart Rate and Cardiovascular Diseases Prognosis in People With Stable Coronary Artery Disease N/A
Completed NCT01826552 - Comparison of the Angiographic Result of the Orsiro Hybrid Stent With Resolute Integrity Stent Phase 4
Not yet recruiting NCT01162902 - Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation Phase 4
Completed NCT02126150 - United Coronary Biobanks N/A
Completed NCT01769079 - Clinical Impact of the Withdrawal of Nitrate in Patients With Stable Angina Phase 4
Completed NCT01328470 - Effect of Platelet Inhibition According to Clopidogrel Dose in Patients With Chronic Kidney Disease Phase 4
Unknown status NCT00751491 - Clopidogrel Versus Adenosin in Non Urgent Percutaneous Coronary Intervention (PCI) Phase 3
Completed NCT00263263 - RRISC Study: Reduction of Restenosis In Saphenous Vein Grafts With Cypher Sirolimus-Eluting Stent. Phase 2
Active, not recruiting NCT04929496 - Physiology as Guidance to Evaluate the Direct Impact of Coronary Lesion Treatment: The PREDICT Study N/A
Completed NCT03103620 - Safety and Effectiveness Evaluation of COBRA PzF Coronary Stent System: A Post Marketing Observational Registry
Recruiting NCT05459051 - Finding the Invasive Haemodynamic Threshold for Symptom Relief in Stable Angina
Completed NCT06464276 - Effectiveness and Tolerability of Trimetazidine 80mg Once Daily in Patients With Chronic Coronary Syndrome: The V-GOOD Study
Not yet recruiting NCT04403048 - Drug Coated Balloon for Side Branch Treatment vs. Conventional Approach in True Bifurcation Coronary Disease: PRO-DAVID N/A
Completed NCT01974492 - Comparison of Saphenous Vein Graft Harvested From Upper Versus Lower Leg in Coronary Artery Bypass Grafting N/A
Completed NCT02120859 - Optical Coherence Tomography to Investigate FFR-Guided DEB-only Elective Coronary Angioplasty Phase 4
Completed NCT01990924 - Low Rate Fluoroscopy to Reduce Radiation Dose During Coronary Angiography and Intervention N/A