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SmartCardia for the Detection of Myocardial Ischemia in Coronary Artery Disease (Smartschemia)

19. mars 2021 oppdatert av: Niccolo' Maurizi, Centre Hospitalier Universitaire Vaudois

Clinical Use of the SmartCardia Wireless Recorder for the Detection of Myocardial Ischemia in the Setting of Coronary Artery Disease: a Single Arm, Prospective Trial

Coronary artery disease and myocardial ischemia are among the leading causes of death and disability in the Westerns countries. Timely and accurate diagnosis of myocardial ischemia at the moment of symptom onset is crucial and often delayed. Portable smart medical devices nowadays offers the possibility of ubiquitous self multi-parametric monitoring. Application of such technologies to timely and autonomous detection of myocardial ischemia could be an effective strategy to an earlier and better treatment of symptomatic coronary artery disease.

The primary objective is to assess the changes in recorded by the SmartCardia patch (respiratory rate, pulse transit time, heart rate and single ECG trace) during induced ischemia during elective coronary angioplasty procedures.

The secondary objective is to asses whether myocardial ischemia can be predicted and quantified by changes in the parameters recorded by SmartCardia patch (respiratory rate, pulse transit time, heart rate and single ECG trace).

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Coronary artery disease and myocardial ischemia are among the leading causes of death and disability in the Westerns countries. Timely and accurate diagnosis of myocardial ischemia at the moment of symptom onset is crucial and often delayed. Portable smart medical devices nowadays offers the possibility of ubiquitous self multi-parametric monitoring. Application of such technologies to timely and autonomous detection of myocardial ischemia could be an effective strategy to an earlier and better treatment of symptomatic coronary artery disease.

The primary objective is to assess the changes in recorded by the SmartCardia patch (respiratory rate, pulse transit time, heart rate and single ECG trace) during induced ischemia during elective coronary angioplasty procedures.

The secondary objective is to asses whether myocardial ischemia can be predicted and quantified by changes in the parameters recorded by SmartCardia patch (respiratory rate, pulse transit time, heart rate and single ECG trace).

SmartWearable devices will be applied 30 minutes before coronary angiography (2/3 devices per-patients would be applied). Percutaneous coronary intervention will be conducted following a given protocol (not influencing patient's treatement):

  1. Myocardial ischemia will be measured with the Fractional Flow Reserve (FFR) wire during stent expansion (total artery occlusion caused by balloon inflation). This will have no impact on patients' management as the wire will already have been inserted for the diagnostic procedure and will not have an impact on procedure duration.
  2. Recording of a 6 leads electrocardiogram during the ischemia phase, which is anyway always available as part of our routine monitoring system.
  3. Patients will systematically be asked for any chest pain or discomfort during ischemia (step which is anyway frequently done in standard procedures), to differentiate between clinical and subclinical ischemia.

At the end of the procedure, the device will be kept during 30 supplementary minutes while the patient is on standard post percutaneous coronary intervention (PCI) surveillance, thus offering measurements during recovery from ischemia.

Studietype

Intervensjonell

Registrering (Forventet)

50

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Sveits
      • Lausanne, Sveits, 1009
        • Centre Hospitalier Universitaire Vaudois

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • ≥18 years old patients
  • Known coronary artery disease
  • Admitted for elective coronary angiography with planned PCI
  • Informed consent signed

Exclusion Criteria:

  • urgent procedure with possible ongoing ischemia before procedure (i.e. STEMI and NSTEMI in the acute phase)
  • Recent acute coronary syndrome (i.e. STEMI and/or NSTEMI <48h or with persistent ST elevation)
  • Admission for revascularization of a total chronic occlusion
  • Known severe valvular disease
  • Decompensated heart-failure
  • Decompensated pulmonary condition (such as COPD)
  • Pregnant and breast-feeding women
  • Patients with prior CABG
  • Patients with severe renal failure (eGFR < 30ml/mn)
  • Vulnerable patients (minors, participants incapable of judgment or participants under tutelage)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Patients undergoing coronary angiography with planned PCI
Patients with a known coronary artery disease admitted for elective coronary angiography with planned PCI would be enrolled
Enhet: Application of Class II A device SmartCardia
Application of SmartCardia monitor patch 30 minutes before coronary angiography (2/3 devices per-patients would be applied). Non invasive recording of single-lead ECG, respiratory rate, pulse transit time, heart rate would occur pre, during and post (30 minutes) primary angioplasty procedure
Andre navn:
  • SmartCardia multiparametric Device

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Assessment of Ischemia detection
Tidsramme: During Coronary Revascularisation procedure
Assessment of whether myocardial ischemia induced differences would be recorded by the SmartCardia patch by estimating the effect size observed on each individual parameter recorded by the device for each patient, comparing the values measured on pre- and during-ischemia intervals.
During Coronary Revascularisation procedure

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Assessment of ischemia severity
Tidsramme: During Coronary Revascularisation procedure
Establishment of dose-response curve between the recorded parameters by Smart-Cardia and the ischemia severity (based of distal coronary artery pressure)
During Coronary Revascularisation procedure
Model description for coloration between ischemia severity and parameters recorded
Tidsramme: During Coronary Revascularisation procedure
Integration of multiple parameters into a more complex model to increase level of correlation between the recorded parameters and the severity of ischemia
During Coronary Revascularisation procedure

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Centre Hospitalier Universitaire Vaudois

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

1. april 2021

Primær fullføring (Forventet)

1. august 2021

Studiet fullført (Forventet)

1. september 2021

Datoer for studieregistrering

Først innsendt

21. februar 2021

Først innsendt som oppfylte QC-kriteriene

19. mars 2021

Først lagt ut (Faktiske)

23. mars 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. mars 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. mars 2021

Sist bekreftet

1. mars 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2021-0000

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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