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SmartCardia for the Detection of Myocardial Ischemia in Coronary Artery Disease

NCT04810845 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-03-23

No results posted yet for this study

Summary

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).

Conditions

  • Myocardial Ischemia

Interventions

DEVICE

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Vaudois

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-30
Primary Completion
2021-08-31
Completion
2021-09-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04810845 on ClinicalTrials.gov