I20 I25 I24
Conditions
Interventions
Group 1: Bicycle stress-test because of a justified suspicion of cardiac ischemia is the non study-related test which qualifies patients for the trial and is carried out according to current guideline
Sponsors
Charité - Universitätsmedizin Berlin
Campus Virchow Klinikum
Med. Klinik m. S. Kardiologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patient is willing and able to give written informed consent -Indication for ergometry for the diagnosis of cardiac ischemia: Coronary artery disease-specific signs and symptoms and/or at least to of the following risk factors for coronary artery disease: -Diabetes mellitus -Arterial hypertension -Hyperlipidemia -Smoking -positive family history of CAD
Exclusion criteria
Exclusion criteria: Patient is not able to conduct the study due to his/her health status Ergometry indicated for non-CAD related reasons Detention by law
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proof of a coronaryx stenosis in which treatment is rquired. This will be assessed by obtaining the report of the coronary angiography in case that in the follow-up the patient reports coronary angiography following the result of his stress test. Information about a coronary angiography will also be obtained via the patients GP. | — |
Secondary
| Measure | Time frame |
|---|---|
| MACE at 90 days Cardiovascular death Re-hospitalisation for suspected acute coronary syndrome or congestive heart failure Acute Myocardial Infarction (AMI) Acute unplanned PCI CABG Documented life-saving arrhythmias or survived sudden cardiac arrest Assessment in 6 months-follow-up, in case of re-hospitalization patient documents will be requested || Development of Choline levels before ans after stress test (Whole blood and plasma choline). Blood sampling immediately before stress test, 30 minutes after the stress test and 8-24 hours after the stress test. For whole blood choline whole blood samples remain at room temperature for 30 minutes after withdrawal and are then frozen at -20°C, within a maximum of 14 days at -80°C. For plasma choline plasma is stored on ice immediately after withdrawal and is processed within a maximum time of 2 hours until freezing. All samples are analyzed en bloc after the whole trial data set has been completed. The test assay will be chosen after the data set is complete. || Development of Copeptin levels before and after stress test. Time points for the blood draws see above. For Copeptin analysis EDTA plasma is stored on ice immediately after withdrawal and is processed within a maximum time of 2 hours until freezing. Samples are frozen at -20°C, within a maximum of 14 days at -80°C. All samples are analyzed en bloc after the whole trial data set has been completed. Copeptin will be measured using the BRAHMS sandwich immune-luminometric assay. || Development of sensitive Troponin I levels before and after stress test. Time points for the blood draws see above. For sensitive Troponin EDTA plasma is stored on ice immediately after withdrawal and is processed within a maximum time of 2 hours until freezing. Samples are then frozen at -20°C, within a maximum of 14 days at -80°C. All samples are analyzed en bloc after the whole trial data set has been completed. An appropiate assay for the analysis will be chosen after the data set is co | — |
Countries
Germany
Contacts
Public ContactDieter Gälke
Facharztpraxis für Innere Medizin
Outcome results
None listed