- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01407250
PhysioGlove Versus Clinic Electrocardiogram Comparison (CommwellPG)
Reliability of Outpatient Electrocardiogram Recordings in Patients Refered for a Cardiology Consultation
Studieoversigt
Status
Detaljeret beskrivelse
The correct performance of a 12 lead electrocardiogram depends on the correct placement of the electrocardiogram electrodes in internationally agreed upon anatomic locations on the patient's limbs and chest. This process requires specific training and diligence on the part of the electrocardiogram performer. The literature points towards a progressive quality degradation of the electrocardiogram performance probably due to the delegation of it's performance to lesser trained individuals. This study is attempting to ascertain the quality of the electrocardiogram recordings performed in non-specialized out patient clinics.
For this purpose we will compare outpatient electrocardiograms of patients referred to a cardiological consultation with electrocardiogram's acquired using a conventional electrocardiogram cable as well as the PhysioGlove-ES by the well training cardiology clinic personnel.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Natanya, Israel
- Clalit- Cardiology consult clinic
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria: all consenting male and female patients age 18-95 -
Exclusion Criteria:
- All patients using shirt-sizes under small mand over extra-large
- all patients with severe chest malformations or open wounds or contagious skin infections involving the chest and/or arms -
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Comparison of the technical and diagnostic quality of outpatient clinic electrocardiogram with the on-site (cardiology consultation clinic) performed electrocardiograms
Tidsramme: Each patient will be tested once while visiting the cardiology consultation clinic. No further patient follow-up is planed. Data collection and evaluation is estimated at 6-9 months from study initiation
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The cardiology clinic electrocardiogram will be compared to the out-patient electrocardiogram brought by the patient to the cardiology consultant
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Each patient will be tested once while visiting the cardiology consultation clinic. No further patient follow-up is planed. Data collection and evaluation is estimated at 6-9 months from study initiation
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- Commwell PG 101
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