NCT04810845

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 23, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

February 21, 2021

Last Update Submit

March 19, 2021

Conditions

Myocardial Ischemia

Keywords

ischemia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Assessment of ischemia severity

    During Coronary Revascularisation procedure

  • Model description for coloration between ischemia severity and parameters recorded

    During Coronary Revascularisation procedure

Study Arms (1)

Patients undergoing coronary angiography with planned PCI

EXPERIMENTAL

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

Interventions

Application of Class II A device SmartCardiaDEVICE

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

Also known as: SmartCardia multiparametric Device
Patients undergoing coronary angiography with planned PCI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, 1009, Switzerland

Location

MeSH Terms

Conditions

Myocardial IschemiaIschemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Niccolo' Maurizi, MD

CONTACT

0041 079 5568 981niccolo.maurizi@chuv.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Cardiology Fellow

Study Record Dates

First Submitted

February 21, 2021

First Posted

March 23, 2021

Study Start

April 1, 2021

Primary Completion

August 1, 2021

Study Completion

September 1, 2021

Last Updated

March 23, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)