Thromboembolism Clinical Trial
Official title:
Assessment of the Hemostatic System, Thromboembolic Complications and Cardiovascular Events in Patients With Cardiovascular Implantable Electronic Devices
NCT number | NCT04499612 |
Other study ID # | 05/290120 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2020 |
Est. completion date | November 1, 2023 |
Verified date | October 2022 |
Source | Ryazan State Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 250 |
Est. completion date | November 1, 2023 |
Est. primary completion date | November 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Ryazan State Medical University | Ryazan' | Ryazan |
Lead Sponsor | Collaborator |
---|---|
Ryazan State Medical University |
Russian Federation,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | |
Primary | 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 | Hemostasis system markers deviations. | Deviation of investigated markers of the hemostasis system from normal values. | Up to 2 years after enrollment (according to the study design). |
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