Influence of Cardiac Implantable Electronic Devices on the Hemostatic System

NCT04499612 | Completed

• 1 other identifier: 05/290120
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Thromboembolism; Cardiac Event; Hemostatic Disorder

Keywords

Cardiac implantable electronic devices; Pacing; Hemostasis; Thromboembolism; Cardiovascular events; Arrhythmias; Atrial fibrillation; Chronic heart failure

Outcome Measures

Primary Outcomes (2)

• Development of thromboembolism: venous thrombosis, pulmonary embolism, arterial thrombosis, arterial thromboembolism, transient ischemic attack, stroke.

  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.

  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 Outcomes (1)

• Hemostasis system markers deviations.

  Up to 2 years after enrollment (according to the study design).

Study Arms (5)

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.; Diagnostic Test: Duplex ultrasound.; Diagnostic Test: Echocardiography.; Diagnostic Test: Blood sampling.

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.; Diagnostic Test: Duplex ultrasound.; Diagnostic Test: Echocardiography.; Diagnostic Test: Blood sampling.

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.; Diagnostic Test: Duplex ultrasound.; Diagnostic Test: Echocardiography.; Diagnostic Test: Blood sampling.

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.; Diagnostic Test: Duplex ultrasound.; Diagnostic Test: Echocardiography.; Diagnostic Test: Blood sampling.

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.; Diagnostic Test: Echocardiography.; Diagnostic Test: Blood sampling.

Interventions

Cardiac implantable electronic device implantation. PROCEDURE

Patients who have indications will receive cardiac implantable electronic device implantation.

Group "Dual-chamber CIED + Atrial fibrillation" (A3); Group "Dual-chamber CIED" (A2); Group "Single-chamber CIED" (A1)

Cardiac implantable electronic device replace. PROCEDURE

Patients who have indications will receive cardiac implantable electronic device replace.

Group "CIED Replace" (B)

Duplex ultrasound. DIAGNOSTIC_TEST

Patients will undergo ultrasound examination of the vessels of the upper and lower extremities.

Group "CIED Replace" (B); Group "Conservative" (C); Group "Dual-chamber CIED + Atrial fibrillation" (A3); Group "Dual-chamber CIED" (A2); Group "Single-chamber CIED" (A1)

Echocardiography. DIAGNOSTIC_TEST

Patients will undergo an ultrasound examination of the heart.

Group "CIED Replace" (B); Group "Conservative" (C); Group "Dual-chamber CIED + Atrial fibrillation" (A3); Group "Dual-chamber CIED" (A2); Group "Single-chamber CIED" (A1)

Blood sampling. DIAGNOSTIC_TEST

Patients will be taken venous blood to determine the studied markers of hemostasis system.

Group "CIED Replace" (B); Group "Conservative" (C); Group "Dual-chamber CIED + Atrial fibrillation" (A3); Group "Dual-chamber CIED" (A2); Group "Single-chamber CIED" (A1)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ryazan State Medical University: lead

Study Sites (1)

Ryazan State Medical University

Ryazan, Ryazan Oblast, Russia

Location

Related Publications (1)

• Kalinin RE, Suchkov IA, Shitov II, Mzhavanadze ND, Povarov VO. [Venous thromboembolic complications in patients with cardiovascular implantable electronic devices]. Angiol Sosud Khir. 2017;23(4):69-74. Russian.

  PMID: 29240058 BACKGROUND

MeSH Terms

Conditions

Thromboembolism; Cardiovascular Diseases; Hemostatic Disorders; Arrhythmias, Cardiac; Atrial Fibrillation

Interventions

Ultrasonography, Doppler, Duplex; Echocardiography; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonography, Doppler; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Cardiac Imaging Techniques; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Igor A. Suchkov, MD, DSc

  Ryazan State Medical 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: July 24, 2020
• First Posted: August 5, 2020
• Study Start: March 1, 2020
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: November 18, 2023

Record last verified: 2022-10

Locations

RU (1)