Influence of Cardiac Implantable Electronic Devices on the Hemostatic System

Sponsor

Ryazan State Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04499612

Collaborator

(none)

250

Enrollment

Location

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Thromboembolism Cardiac Event Hemostatic Disorder	Procedure: Cardiac implantable electronic device implantation. Procedure: Cardiac implantable electronic device replace. Diagnostic Test: Duplex ultrasound. Diagnostic Test: Echocardiography. Diagnostic Test: Blood sampling.

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 Design

Study Type:

Observational

Anticipated Enrollment :

250 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2020

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
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).	Procedure: Cardiac implantable electronic device replace. Patients who have indications will receive cardiac implantable electronic device replace. 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 "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.

Outcome Measures

Primary Outcome Measures

Development of thromboembolism: venous thrombosis, pulmonary embolism, arterial thrombosis, arterial thromboembolism, transient ischemic attack, stroke. [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.
Development of cardiovascular event: myocardial infarction, acute coronary syndrome, atrial fibrillation, decompensation of chronic heart failure. [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.

Secondary Outcome Measures

Hemostasis system markers deviations. [Up to 2 years after enrollment (according to the study design).]
Deviation of investigated markers of the hemostasis system from normal values.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.