SmartCardia for the Detection of Myocardial Ischemia in Coronary Artery Disease (Smartschemia)
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).
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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):
- 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.
- Recording of a 6 leads electrocardiogram during the ischemia phase, which is anyway always available as part of our routine monitoring system.
- 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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Lausanne, Suisse, 1009
- Centre Hospitalier Universitaire Vaudois
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
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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
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Assessment of Ischemia detection
Délai: During Coronary Revascularisation procedure
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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.
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During Coronary Revascularisation procedure
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Assessment of ischemia severity
Délai: During Coronary Revascularisation procedure
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Establishment of dose-response curve between the recorded parameters by Smart-Cardia and the ischemia severity (based of distal coronary artery pressure)
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During Coronary Revascularisation procedure
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Model description for coloration between ischemia severity and parameters recorded
Délai: During Coronary Revascularisation procedure
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Integration of multiple parameters into a more complex model to increase level of correlation between the recorded parameters and the severity of ischemia
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During Coronary Revascularisation procedure
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2021-0000
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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