- ICH GCP
- Register voor klinische proeven in de VS.
- Clinical Trials Nct-pagina
3D ECG for Detection of Cardiomyopathy
3D ECG for Detection of Cardiomyopathy in Heart Failure
| Sponsors |
Hoofdsponsor: University Hospital, Essen |
|---|---|
| Bron | University Hospital, Essen |
| Korte samenvatting | There is existing data in the literature that suggests an additional predictive value of three dimensional ECG with respect to the presence of electrical abnormalities and for an existing cardiac disease. Especially regarding patients who suffered from a myocardial infarction in the past (post MI patients), evidence has been provided for a potential association of 3D repolarisation abnormalities and incidence of sudden cardiac death (SCD). In addition, there is some vague evidence of so called 3D ECG and prediction of coronary artery disease. This 3D ECG device is using the technology of 3D ECG vector loops and is assessing the variability of these ECG vector loops in the 3-dimensional space. Based on these data, the parameters of 3D ECG are suggested to carry certain value to predict or to identify individuals already suffering from a cardiac disease or being at risk experiencing a cardiac event in the future. In this context we performed a preliminary study with 3D-ECG device in healthy volunteers evaluating the robustness of this method with respect to reproducibility, intra- and intra-observer variability which could be confirmed. We thus postulate that the 3D ECG technology might bear the potential to serve as a sufficient screening method for diagnosing cardiomyopathy in patients with an unknown heart failure etiology. |
| Algemene status | Recruiting | ||||
|---|---|---|---|---|---|
| Startdatum | 2021-03-14 | ||||
| einddatum | 2021-10-14 | ||||
| Primaire voltooiingsdatum | 2021-09-14 | ||||
| Studietype | Observational | ||||
| Primaire uitkomst |
|
||||
| Inschrijving | 175 |
| Staat | |
|---|---|
| Interventie |
Type interventie: Diagnostic Test Interventienaam: 3D-ECG Omschrijving: Patient recieves 3D-ECG Assessement Armgroeplabel: Patient recieving 3D-ECG-Evaluation |
| Geschiktheid |
Bemonsteringsmethode: Probability Sample
Criteria:
Inclusion Criteria: - Age >18 Years - Established diagnosis heart failure and suggested cardiomyopathy Exclusion Criteria: - Patients unable to sign informed consent - Pacemaker-stimulated ECG Geslacht: All Minimum leeftijd: 18 Years Maximale leeftijd: N/A Gezonde vrijwilligers: No |
| Algemeen ambtenaar |
|
||||||
|---|---|---|---|---|---|---|---|
| Algemeen contact |
Achternaam: Reza Wakili, Prof. Telefoon: 00492017234802 E-mail: reza.wakili@uk-essen.de |
||||||
| Plaats |
|
| Locatie Landen |
Germany |
|---|---|
| Verificatiedatum |
2021-04-01 |
| Verantwoordelijke partij |
Type: Sponsor |
| Heeft uitgebreide toegang | No |
| Conditie Bladeren | |
| Arm groep |
Label: Patient recieving 3D-ECG-Evaluation |
| Patiëntgegevens | No |
| Bestudeer ontwerpinformatie |
Observationeel model: Cohort Tijdsperspectief: Prospective |
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Klinische onderzoeken op Heart Failure
-
NCT05806970Nog niet aan het wervenVoorwaarden: Heart Failure With Reduced Ejection Fraction
-
NCT05806606Nog niet aan het wervenVoorwaarden: Heart Failure, Self Care, Empowerment, Transitional Care, Disease Management
-
NCT05802563Inschrijven op uitnodigingVoorwaarden: Atrial Fibrillation, Heart Failure, Systolic
-
NCT05802849Nog niet aan het wervenVoorwaarden: Chronic Heart Failure
-
NCT05792059WervingVoorwaarden: Heart Failure With Preserved Ejection Fraction (HFpEF)
-
NCT05797649Nog niet aan het wervenVoorwaarden: Pleural Effusion, Heart Failure, Malignant Neoplasm, Fluid Overload, Hypoalbuminemia, Renal Failure, Cirrhosis, Infections
-
NCT05799638Nog niet aan het wervenVoorwaarden: Heart Failure With Reduced Ejection Fraction
-
NCT05778084WervingVoorwaarden: Heart Failure With Reduced Ejection Fraction
-
NCT05791227Nog niet aan het wervenVoorwaarden: Heart Failure