ThromboembolismNCT04499612
Influence of Cardiac Implantable Electronic Devices on the Hemostatic System
An observational study of Thromboembolism and Cardiac Event, run by Ryazan State Medical University at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Thromboembolism, Cardiac Event, Hemostatic Disorder
- What is being tested?
- Cardiac implantable electronic device implantation., Cardiac implantable electronic device replace. and Duplex ultrasound.
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteRussia
- Study dates
- 1 Mar 2020to 1 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- active cancer or a remission period of less than 5 years;
- decompensated somatic pathology;
- pregnancy or breastfeeding in women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Thromboembolism, Cardiac Event, Hemostatic Disorder
- Being tested
- Cardiac implantable electronic device implantation., Cardiac implantable electronic device replace., Duplex ultrasound., Echocardiography., Blood sampling.
- Keywords
- Cardiac implantable electronic devices, Pacing, Hemostasis, Thromboembolism, Cardiovascular events, Arrhythmias, Atrial fibrillation, Chronic heart failure
- Medical subject headings
- Thromboembolism, Cardiovascular Diseases, Hemostatic Disorders, Arrhythmias, Cardiac, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac implantable electronic device implantation.Procedure or surgery
Patients who have indications will receive cardiac implantable electronic device implantation.
Cardiac implantable electronic device replace.Procedure or surgery
Patients who have indications will receive cardiac implantable electronic device replace.
Duplex ultrasound.Diagnostic test
Patients will undergo ultrasound examination of the vessels of the upper and lower extremities.
Echocardiography.Diagnostic test
Patients will undergo an ultrasound examination of the heart.
Blood sampling.Diagnostic test
Patients will be taken venous blood to determine the studied markers of hemostasis system.
| Study group | Role | What they receive |
|---|---|---|
| Group "Single-chamber CIED" (A1) | 50 patients with permanent atrial fibrillation and indications for cardiac implantable electronic device implantation (single-chamber system). Receives: 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). Receives: 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). Receives: 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). Receives: 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). Receives: Diagnostic Test: Duplex ultrasound.; Diagnostic Test: Echocardiography.; Diagnostic Test: Blood sampling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 2 years after enrollment (according to the study design).
Secondary outcomes (1)
Hemostasis system markers deviations.
Deviation of investigated markers of the hemostasis system from normal values.
Measured: Up to 2 years after enrollment (according to the study design).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start1 Mar 2020
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ryazan State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Igor A. Suchkov, MD, DSc, Principal investigator, Ryazan State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499612
- Sponsor's protocol ID
- 05/290120
- Status last verified
- Oct 2022
- First submitted
- 24 Jul 2020
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Basic demographic data, including sex, age, and ethnicity are to be shared if allowed by the privacy policy.
Publications
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.
PubMed 29240058
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Hemostatic System, Thromboembolic Complications and Cardiovascular Events in Patients With Cardiovascular Implantable Electronic Devices
- ClinicalTrials.gov ID
- NCT04499612
- Acronym / sponsor ID
- 05/290120
- Conditions
- Thromboembolism, Cardiac Event, Hemostatic Disorder
- Keywords
- Cardiac implantable electronic devices, Pacing, Hemostasis, Thromboembolism, Cardiovascular events, Arrhythmias, Atrial fibrillation, Chronic heart failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Ryazan State Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group "Single-chamber CIED" (A1) | – | Procedure: Cardiac implantable electronic device implantation., Diagnostic Test: Duplex ultrasound., Diagnostic Test: Echocardiography., Diagnostic Test: Blood sampling.50 patients with permanent atrial fibrillation and indications for cardiac implantable electronic device implantation (single-chamber system). |
| Group "Dual-chamber CIED" (A2) | – | Procedure: Cardiac implantable electronic device implantation., Diagnostic Test: Duplex ultrasound., Diagnostic Test: Echocardiography., Diagnostic Test: Blood sampling.50 patients with atrioventricular block/sick sinus syndrome and indications for cardiac implantable electronic device implantation (dual-chamber system). |
| Group "Dual-chamber CIED + Atrial fibrillation" (A3) | – | Procedure: Cardiac implantable electronic device implantation., Diagnostic Test: Duplex ultrasound., Diagnostic Test: Echocardiography., Diagnostic Test: Blood sampling.50 patients with atrioventricular block/sick sinus syndrome, paroxysmal or persistent atrial fibrillation and indications for cardiac implantable electronic device implantation (dual-chamber system). |
| Group "CIED Replace" (B) | – | Procedure: Cardiac implantable electronic device replace., Diagnostic Test: Duplex ultrasound., Diagnostic Test: Echocardiography., Diagnostic Test: Blood sampling.50 patients with cardiac implantable electronic device implantation 6-12 years ago (single- or dual-chamber system). |
| Group "Conservative" (C) | – | Diagnostic Test: Duplex ultrasound., Diagnostic Test: Echocardiography., Diagnostic Test: Blood sampling.50 patients with atrioventricular block/sick sinus syndrome/atrial fibrillation and without indications for cardiac implantable electronic device implantation (conservative group). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- active cancer or a remission period of less than 5 years;
- decompensated somatic pathology;
- pregnancy or breastfeeding in women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac implantable electronic device implantation.Patients who have indications will receive cardiac implantable electronic device implantation. | Procedure or surgery | Group "Dual-chamber CIED + Atrial fibrillation" (A3), Group "Dual-chamber CIED" (A2), Group "Single-chamber CIED" (A1) |
| Cardiac implantable electronic device replace.Patients who have indications will receive cardiac implantable electronic device replace. | Procedure or surgery | Group "CIED Replace" (B) |
| Duplex ultrasound.Patients will undergo ultrasound examination of the vessels of the upper and lower extremities. | Diagnostic test | 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.Patients will undergo an ultrasound examination of the heart. | Diagnostic test | 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.Patients will be taken venous blood to determine the studied markers of hemostasis system. | Diagnostic test | Group "CIED Replace" (B), Group "Conservative" (C), Group "Dual-chamber CIED + Atrial fibrillation" (A3), Group "Dual-chamber CIED" (A2), Group "Single-chamber CIED" (A1) |
Primary outcome
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.
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.
1 secondary outcome
Hemostasis system markers deviations.
Time frame: Up to 2 years after enrollment (according to the study design).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Background: PubMed 29240058Kalinin 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.
- Individual participant dataSharing planned: Undecided. Basic demographic data, including sex, age, and ethnicity are to be shared if allowed by the privacy policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Igor A. Suchkov, MD, DSc principal investigator
Ryazan State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thromboembolism and Cardiac Event, run by Ryazan State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04499612, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.