Determination of Diastolic Dysfunction by Single Lead Electrocardiogram

NCT04474639 | Completed DMC

• 1 other identifier: 1305
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

It is a prospective, controlled, single-center, non-randomized, observational study. From September 2019 to December 2020, the study plans to prospectively include 400 patients aged 18 to 90 years. Every patients will undergo an echocardiographic examination with assessment diastolic dysfunction of the left ventricle, and registration of an electrocardiogram using a single lead ECG monitor CardioQvark (in I standard lead) for 3 minutes. All patients will be divided into 2 main groups: with diastolic dysfunction of the left ventricle, confirmed by the results of the echocardiography and without. A spectral analysis of the electrocardiogram will be performed using a continuous wavelet transform. The result of this study will be the identification of ECG parameters that will correlate with LV diastolic dysfunction.

Conditions

Diastolic Function

Keywords

diastolic function; heart failure; spectral analysis

Outcome Measures

Primary Outcomes (6)

• determination of sensitivity of LV DD using a single-channel ECG monitor CardioQvark

  comparison of the presence of LV DD detected by the results of an echocardiographic study with the results of the presence of LV DD obtained using the mathematical model of a single-channel ECG of the CardioQvark monitor

  through study completion, an average of 2 years

• determination of specificity of LV DD using a single-channel ECG monitor CardioQvark

  comparison of the presence of LV DD detected by the results of an echocardiographic study with the results of the presence of LV DD obtained using the mathematical model of a single-channel ECG of the CardioQvark monitor

  through study completion, an average of 2 years

• determination of prognostic value of positive and negative results of LV DD using a single-channel ECG monitor CardioQvark

  comparison of the presence of LV DD detected by the results of an echocardiographic study with the results of the presence of LV DD obtained using the mathematical model of a single-channel ECG of the CardioQvark monitor

  through study completion, an average of 2 years

• determination of likelihood ratio of LV DD using a single-channel ECG monitor CardioQvark

  comparison of the presence of LV DD detected by the results of an echocardiographic study with the results of the presence of LV DD obtained using the mathematical model of a single-channel ECG of the CardioQvark monitor

  through study completion, an average of 2 years

• determination of area under ROC - curve of LV DD using a single-channel ECG monitor CardioQvark

  comparison of the presence of LV DD detected by the results of an echocardiographic study with the results of the presence of LV DD obtained using the mathematical model of a single-channel ECG of the CardioQvark monitor

  through study completion, an average of 2 years

• determination of correlation coefficient of LV DD using a single-channel ECG monitor CardioQvark

  comparison of the presence of LV DD detected by the results of an echocardiographic study with the results of the presence of LV DD obtained using the mathematical model of a single-channel ECG of the CardioQvark monitor

  through study completion, an average of 2 years

Secondary Outcomes (16)

• significance of the parameter TpTe on the ECG in the determination of LV DD

  through study completion, an average of 2 years

• significance of the parameter VAT on the ECG in the determination of LV DD

  through study completion, an average of 2 years

• significance of the parameter QTc on the ECG in the determination of LV DD

  through study completion, an average of 2 years

• significance of the parameter QT / TQ on the ECG in the determination of LV DD

  through study completion, an average of 2 years

• significance of the parameter QRS_E on the ECG in the determination of LV DD

  through study completion, an average of 2 years

Study Arms (2)

with diastolic dysfunction

patients with diastolic dysfunction of the left ventricle confirmed by the results of the echocardiography (septal e' \>=8, and lateral e'\>=10 and left atrium \<34 ml/m2) and by results of the spectral analysis of electrocardiogram (the parameters listed below will be calculated as the median of the tact-cycle: TpTe, VAT, QTc, QT / TQ, QRS\_E, T\_E, TP\_E, BETA, BETA\_S, BAD\_T, QRS\_D1\_ons, QRS\_D1\_offs, QRS\_D2, QRS\_Ei (i = 1,2,3,4), T\_Ei (i= 1,2,3,4), HFQRS, QRSw, RA, SA, TA).

Device: echocardiographic examination

without diastolic dysfunction

patients without diastolic dysfunction of the left ventricle confirmed by the results of the echocardiography (septal e'\<8, and lateral e'\<10 and left atrium \>=34 ml/m2) and by results of the spectral analysis of electrocardiogram (the parameters listed below will be calculated as the median of the tact-cycle: TpTe, VAT, QTc, QT / TQ, QRS\_E, T\_E, TP\_E, BETA, BETA\_S, BAD\_T, QRS\_D1\_ons, QRS\_D1\_offs, QRS\_D2, QRS\_Ei (i = 1,2,3,4), T\_Ei (i= 1,2,3,4), HFQRS, QRSw, RA, SA, TA).

Device: echocardiographic examination

Interventions

echocardiographic examination DEVICE

conducting an echocardiographic study according to a standard protocol with the determination of diastolic dysfunction of the left ventricle

with diastolic dysfunction; without diastolic dysfunction

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all patients aged 18 to 90 years

You may qualify if:

• The presence of written informed consent of the patient to participate in the study
• Age from 18 years to 90 years
• Outpatient treatment and / or hospitalization in a research center

You may not qualify if:

• Reluctance of the patient to participate in the study
• Poor quality ECG recording on a single-channel ECG monitor
• Poor visualization of the heart during echocardiographic study
• Acute psychotic reactions that arose during research
• An exacerbation of chronic diseases requiring treatment tactics for the patient and preventing his further participation in the study.
• The presence of conduction disturbances in patients that impede ECG analysis (WPW syndrome, sinoatrial block of degrees 2 and 3, atrioventricular block 3 degrees, complete block of the left bundle branch block, complete block of the right bundle branch block)
• Conditions that can impair ECG recording quality (Parkinson's disease, essential tremor)
• The inability to assess diastolic function during echocardiography
• Mental illness
• Diseases with an expected life expectancy of less than 2 years
• Patients with diffuse hypokinesis of the left ventricle with a reduced ejection fraction (less than 30%)
• Patients with a pacemaker installed

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

I.M. Sechenov First Moscow State Medical University (Sechenov University)

Moscow, Russia

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Philipp Kopylov

  I.M. Sechenov First Moscow State Medical University (Sechenov University)

  STUDY DIRECTOR

• Natalia Kuznetsova

  I.M. Sechenov First Moscow State Medical University (Sechenov University)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: July 17, 2020
• Study Start: September 1, 2019
• Primary Completion: June 30, 2021
• Study Completion: August 29, 2021
• Last Updated: August 31, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)