Determination of Diastolic Dysfunction by Single Lead Electrocardiogram (NCT04474639) | Clinical Trial Compass
CompletedNot Applicable
Determination of Diastolic Dysfunction by Single Lead Electrocardiogram
Russia400 participantsStarted 2019-09-01
Plain-language 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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Non-inclusion criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
determination of sensitivity of LV DD using a single-channel ECG monitor CardioQvark
Timeframe: through study completion, an average of 2 years
2
determination of specificity of LV DD using a single-channel ECG monitor CardioQvark
Timeframe: through study completion, an average of 2 years
3
determination of prognostic value of positive and negative results of LV DD using a single-channel ECG monitor CardioQvark
Timeframe: through study completion, an average of 2 years
4
determination of likelihood ratio of LV DD using a single-channel ECG monitor CardioQvark
Timeframe: through study completion, an average of 2 years
5
determination of area under ROC - curve of LV DD using a single-channel ECG monitor CardioQvark
Timeframe: through study completion, an average of 2 years
6
determination of correlation coefficient of LV DD using a single-channel ECG monitor CardioQvark
Timeframe: through study completion, an average of 2 years
Trial details
NCT IDNCT04474639
SponsorI.M. Sechenov First Moscow State Medical University