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).

Study Overview

• Status: Unknown
• Conditions: Myocardial Ischemia
• Intervention / Treatment: Device: Application of Class II A device SmartCardia

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: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Niccolo' Maurizi, MD; Phone Number: 0041 079 5568 981; Email: niccolo.maurizi@chuv.ch

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Assessment of Ischemia detection	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

Outcome Measure	Measure Description	Time Frame
Assessment of ischemia severity	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	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

• Sponsor: Centre Hospitalier Universitaire Vaudois

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: February 21, 2021
• First Submitted That Met QC Criteria: March 19, 2021
• First Posted (Actual): March 23, 2021

Study Record Updates

• Last Update Posted (Actual): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 19, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: ischemia
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Ischemia
• Other Study ID 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