Influence of Cardiac Implantable Electronic Devices on the Hemostatic System

November 15, 2023 updated by: Ryazan State Medical University

Assessment of the Hemostatic System, Thromboembolic Complications and Cardiovascular Events in Patients With Cardiovascular Implantable Electronic Devices

The hemostasis system is one of the many biological systems of the human body, designed to preserve the liquid state of blood and prevent its loss during vascular injuries. The ideal balance between its coagulant and anticoagulant components never occurs. In various diseases and pathological conditions, the balance of the hemostasis system may be disturbed. Shifts towards hypercoagulability lead to the development of hemorrhagic complications, opposite shifts lead to the development of thrombotic complications.

Patients with cardiac implantable electronic devices (CIED) are not rare and unique, today doctors meet with them every day. Its more than 1.5 million CIED's implanted every year.

Before surgery these patients are standard cardiology department patients with chronic heart failure (CHF), which develops due to the presence of arrhythmias, coronary heart disease, hypertension, congenital heart disease, myocardial infarction, myocarditis or other diseases and conditions. CHF is the most common, severe and unfavorable prognostic complication of these diseases. With CHF, the balance of the hemostasis system shifts towards hypercoagulation. Patients with CHF have an increased risk of arterial and venous thrombosis, pulmonary embolism, myocardial infarction, stroke, numerous brady- and tachyarrhythmias and other complications.

After CIED implantation, bradyarrhythmia is eliminated, as one of the parts in the pathogenesis of CHF. Patients, especially those with severe symptoms, improve their condition in the early postoperative period. In the long-term period, pacing, on the contrary, may contribute to the progression of CHF. The wrong choice of pacing mode or the place of electrode implantation can lead to desynchronization of the heart chambers, myocardial remodeling and left ventricular dysfunction.

Uncertainty is also observed in relation to the hemostasis system after CIED implantation. On the one hand, correction of bradyarrhythmia and CHF should provide patients with a shift towards hypocoagulability by normalizing the heart rate. On the other hand, trauma to the vessel wall during surgery, further placement of the CIED leads in the vessels, and perioperative stress can lead to even greater shifts towards hypercoagulation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

250 patients of similar age, gender, and ethnicity will be divided into five groups: Group A1-3: 150 patients with indications for cardiac implantable electronic device (CIED) implantation; Group B: 50 patients with an CIED implanted 8-10 years ago; Group C: 50 patients with diseases similar to group A, but without indications for CIED implantation; Patients will be followed up for 2 years. Patients of group A1-3 will be taken peripheral venous blood to assess the studied parameters of hemostasis (platelet count, plateletcrit, mean platelet volume, platelet distribution width, von Willebrand factor, P-selectin, coagulation factor I (FI), coagulation factor II (FII), coagulation factor V (FV), coagulation factor VII (FVII), coagulation factor X (FX), coagulation factor VIII (FVIII), coagulation factor IX (FIX), coagulation factor XI (FXI), coagulation factor XII (FXII), plasminogen, soluble fibrin, plasminogen activator inhibitor-1 (PAI-1), D-dimer, antithrombin III, protein C) and duplex ultrasound of the vessels of the upper and lower extremities before the operation, after 7 days, 1 and 12 months after the operation. Similar procedures will be performed for patients of groups B and C only when included in the study. Echocardiography will be performed on all patients at enrollment, after 12 and 24 months of follow-up.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Russian Federation
    • Ryazan
      • Ryazan', Ryazan, Russian Federation
        • Ryazan State Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing treatment in cardiology and cardiac surgery departments who have an implanted cardiac implantable electronic device or have indication/no indication for cardiac implantable electronic device implantation.

Description

Inclusion Criteria:

  • for group A1-3: atrioventricular block/sick sinus syndrome/atrial fibrillation with impaired conduction as indications for cardiac implantable electronic device implantation;
  • for group B: atrioventricular block/sick sinus syndrome/atrial fibrillation with impaired conduction and cardiac implantable electronic device implanted 6-12 years ago;
  • for group C: atrioventricular block/sick sinus syndrome/atrial fibrillation with impaired conduction without indications for cardiac implantable electronic device implantation.

Exclusion Criteria:

  • active cancer or a remission period of less than 5 years;
  • decompensated somatic pathology;
  • pregnancy or breastfeeding in women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Group "Single-chamber CIED" (A1)
50 patients with permanent atrial fibrillation and indications for cardiac implantable electronic device implantation (single-chamber system).
Procedure: Cardiac implantable electronic device implantation.
Patients who have indications will receive cardiac implantable electronic device implantation.
Diagnostic test: Duplex ultrasound.
Patients will undergo ultrasound examination of the vessels of the upper and lower extremities.
Diagnostic test: Echocardiography.
Patients will undergo an ultrasound examination of the heart.
Diagnostic test: Blood sampling.
Patients will be taken venous blood to determine the studied markers of hemostasis system.
Group "Dual-chamber CIED" (A2)
50 patients with atrioventricular block/sick sinus syndrome and indications for cardiac implantable electronic device implantation (dual-chamber system).
Procedure: Cardiac implantable electronic device implantation.
Patients who have indications will receive cardiac implantable electronic device implantation.
Diagnostic test: Duplex ultrasound.
Patients will undergo ultrasound examination of the vessels of the upper and lower extremities.
Diagnostic test: Echocardiography.
Patients will undergo an ultrasound examination of the heart.
Diagnostic test: Blood sampling.
Patients will be taken venous blood to determine the studied markers of hemostasis system.
Group "Dual-chamber CIED + Atrial fibrillation" (A3)
50 patients with atrioventricular block/sick sinus syndrome, paroxysmal or persistent atrial fibrillation and indications for cardiac implantable electronic device implantation (dual-chamber system).
Procedure: Cardiac implantable electronic device implantation.
Patients who have indications will receive cardiac implantable electronic device implantation.
Diagnostic test: Duplex ultrasound.
Patients will undergo ultrasound examination of the vessels of the upper and lower extremities.
Diagnostic test: Echocardiography.
Patients will undergo an ultrasound examination of the heart.
Diagnostic test: Blood sampling.
Patients will be taken venous blood to determine the studied markers of hemostasis system.
Group "CIED Replace" (B)
50 patients with cardiac implantable electronic device implantation 6-12 years ago (single- or dual-chamber system).
Diagnostic test: Duplex ultrasound.
Patients will undergo ultrasound examination of the vessels of the upper and lower extremities.
Diagnostic test: Echocardiography.
Patients will undergo an ultrasound examination of the heart.
Diagnostic test: Blood sampling.
Patients will be taken venous blood to determine the studied markers of hemostasis system.
Procedure: Cardiac implantable electronic device replace.
Patients who have indications will receive cardiac implantable electronic device replace.
Group "Conservative" (C)
50 patients with atrioventricular block/sick sinus syndrome/atrial fibrillation and without indications for cardiac implantable electronic device implantation (conservative group).
Diagnostic test: Duplex ultrasound.
Patients will undergo ultrasound examination of the vessels of the upper and lower extremities.
Diagnostic test: Echocardiography.
Patients will undergo an ultrasound examination of the heart.
Diagnostic test: Blood sampling.
Patients will be taken venous blood to determine the studied markers of hemostasis system.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Development of thromboembolism: venous thrombosis, pulmonary embolism, arterial thrombosis, arterial thromboembolism, transient ischemic attack, stroke.
Time Frame: Up to 2 years after enrollment (according to the study design).
Development of thromboembolic complications after the cardiac implantable electronic device implantation/replace or thromboembolism in conservative group patients during observation period.
Up to 2 years after enrollment (according to the study design).
Development of cardiovascular event: myocardial infarction, acute coronary syndrome, atrial fibrillation, decompensation of chronic heart failure.
Time Frame: Up to 2 years after enrollment (according to the study design).
Development of cardiovascular events after the cardiac implantable electronic device implantation/replace or in conservative group patients during observation period.
Up to 2 years after enrollment (according to the study design).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hemostasis system markers deviations.
Time Frame: Up to 2 years after enrollment (according to the study design).
Deviation of investigated markers of the hemostasis system from normal values.
Up to 2 years after enrollment (according to the study design).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ryazan State Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Igor A. Suchkov, MD, DSc, Ryazan State Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 05/290120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Basic demographic data, including sex, age, and ethnicity are to be shared if allowed by the privacy policy.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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