Pulse Wave Parameters in the Assessment of Systolic Function of the Left Ventricle.

NCT04788342 | Completed DMC

• 1 other identifier: S17022021
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single-center, non-randomized, observational study. The aim of this study is to determine the potential of a single-lead electrocardiogram monitor CardioQvark with photoplethysmography function use to evaluate systolic function of the left ventricle. The study is conducted in the clinic of I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia. It is planned to include 400 patients. Recording of the electrocardiogram and photoplethysmogram by the monitor CardioQvark and the assessment of systolic function using echocardiography will be performed in all study participants. The result of this study will be the identification of the parameters of the pulse wave and electrocardiogram that will correlate with systolic function of the left ventricle. It is also planned to determine the diagnostic effectiveness of this method.

Conditions

Hypertension; Heart Failure

Keywords

pulse wave; systolic function of the left ventricle; ejection fraction; blood pressure; a single-lead electrocardiogram; remote determination of the systolic function

Outcome Measures

Primary Outcomes (8)

• Determination of the comparative characteristics of the pulse wave parameters registered by a single- lead ECG monitor CardioQvark and indicators of systolic function of the left ventricle detected during echocardiography.

  comparison of left ventricular systolic dysfunction detected by echocardiography with the results of the presence of left ventricular systolic dysfunction obtained using the mathematical model of pulse wave and electrocardiogram parameters.

  Through study completion, an average of 1 year.

• Diagnostic accuracy of the pulse wave and electrocardiogram parameters registered by a single- lead ECG monitor CardioQvark.

  comparison of left ventricular systolic dysfunction detected by echocardiography with the results of the presence of left ventricular systolic dysfunction obtained using the mathematical model of pulse wave and electrocardiogram parameters.

  Through study completion, an average of 1 year.

• Determination of the sensitivity of left ventricular systolic dysfunction detected by analysis of the pulse wave and electrocardiogram registered by a single- lead ECG monitor CardioQvark.

  comparison of left ventricular systolic dysfunction detected by echocardiography with the results of the presence of left ventricular systolic dysfunction obtained using the mathematical model of pulse wave and electrocardiogram parameters.

  Through study completion, an average of 1 year.

• Determination of specificity of left ventricular systolic dysfunction detected by analysis of the pulse wave and electrocardiogram registered by a single- lead ECG monitor CardioQvark.

  comparison of left ventricular systolic dysfunction detected by echocardiography with the results of the presence of left ventricular systolic dysfunction obtained using the mathematical model of pulse wave and electrocardiogram parameters.

  Through study completion, an average of 1 year.

• Determination of prognostic value of positive and negative results of left ventricular systolic dysfunction detected by analysis of the pulse wave and electrocardiogram registered by a single-channel ECG monitor CardioQvark.

  comparison of left ventricular systolic dysfunction detected by echocardiography with the results of the presence of left ventricular systolic dysfunction obtained using the mathematical model of pulse wave and electrocardiogram parameters.

  Through study completion, an average of 1 year.

• Determination of area under receiver operating characteristic curve of left ventricular systolic dysfunction detected by analysis of the pulse wave and electrocardiogram registered by a single- lead ECG monitor CardioQvark.

  comparison of left ventricular systolic dysfunction detected by echocardiography with the results of the presence of left ventricular systolic dysfunction obtained using the mathematical model of pulse wave and electrocardiogram parameters.

  Through study completion, an average of 1 year.

• Determination of correlation coefficient of left ventricular systolic dysfunction detected by analysis of the pulse wave and electrocardiogram registered by a single-channel ECG monitor CardioQvark.

  comparison of left ventricular systolic dysfunction detected by echocardiography with the results of the presence of left ventricular systolic dysfunction obtained using the mathematical model of pulse wave and electrocardiogram parameters.

  Through study completion, an average of 1 year.

• assessment of the accuracy of the blood pressure measurement using a single-channel ECG monitor CardioQvark.

  comparison of blood pressure values obtained on the basis of a mathematical model of pulse wave parameters and measured using a cuff-based device.

  Through study completion, an average of 1 year.

Secondary Outcomes (24)

• significance of the parameter TpTe on the ECG in the determination of left ventricular systolic dysfunction

  Through study completion, an average of 1 year.

• significance of the parameter VAT on the ECG in the determination of left ventricular systolic dysfunction

  Through study completion, an average of 1 year.

• significance of the parameter QTc on the ECG in the determination of left ventricular systolic dysfunction

  Through study completion, an average of 1 year.

• significance of the parameter QT / TQ on the ECG in the determination of left ventricular systolic dysfunction

  Through study completion, an average of 1 year.

• significance of the parameter QRS_E on the ECG in the determination of left ventricular systolic dysfunction

  Through study completion, an average of 1 year.

Study Arms (1)

Patients with and without left ventricular systolic dysfunction

Patients with different pathologies of the cardiovascular system (coronary artery disease, hypertension, valvular heart disease, heart failure) will be performed pulse wave recording using a CardioQvark cardiomonitor and echocardiography.

Device: pulse wave recording, echocardiography.

Interventions

pulse wave recording, echocardiography. DEVICE

pulse wave recording using a single-channel electrocardiogram cardiomonitor with photoplethysmography, conducting echocardiography according to a standard protocol with the determination of systolic function of the left ventricle

Also known as: blood pressure measurement

Patients with and without left ventricular systolic dysfunction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with different pathologies of the cardiovascular system (coronary artery disease, hypertension, valvular heart disease, heart failure) aged 18 years and older.

You may qualify if:

• The presence of written informed consent of the patient to participate in the study.
• The presence of diagnosed cardiac pathology according anamnesis (coronary artery disease (I-IV classes according Canadian Cardiovascular Society grading of angina pectoris, post myocardial infarction, patients after percutaneous coronary intervention or coronary artery bypass grafting); hypertension (stages I- III); valvular heart disease (except patients with aortic valve stenosis and mechanical prosthetic heart valve); heart failure (I-IV NYHA).

You may not qualify if:

• \. Patient's reluctance to participate in the study. 2. Poor quality of ECG recording by a single-channel ECG monitor. 3. Poor visualization of the heart during echocardiography.
• The presence of rhythm and conduction disorders (WPW syndrome, frequent premature ventricular complexes, 2nd and 3rd degree sinoatrial block, 3rd degree atrioventricular block, complete left bundle branch block, complete right bundle branch block).
• Patients with permanent cardiac pacemaker, cardio-resynchronization therapy (CRT), implantable cardioverter-defibrillator (ICD).
• Conditions that can impair ECG recording quality (Parkinson's disease, essential tremor, etc.) or conditions that make it difficult to record ECG and photoplethysmogram (traumatic arm amputation)
• Mental illness (diagnosed early)
• Diseases with a life expected expectancy of less than 2 years.
• Pregnancy.

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

Hypertension; Heart Failure

Interventions

Echocardiography; Blood Pressure Determination

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Heart Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Physical Examination

Study Officials

• Petr Chomakhidze, Professor

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

  STUDY DIRECTOR

• Zhanna Sagirova, Graduate

  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: February 16, 2021
• First Posted: March 9, 2021
• Study Start: December 1, 2019
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: December 7, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)