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

March 19, 2021 updated by: 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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
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
Other Names:
  • SmartCardia multiparametric Device

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assessment of Ischemia detection
Time Frame: 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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of ischemia severity
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire Vaudois

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 23, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021-0000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Myocardial Ischemia

Clinical Trials on Application of Class II A device SmartCardia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings