Cardiovascular Disease Clinical Trial
Official title:
Thromboembolic Complications Associated With Pacemaker or Implantable Cardioverter-Defibrillator Procedures: a Prospective Registry
This is a large prospective registry of patients submitted to cardiac electronic devices implantation designed to investigate the incidence, risk factors and prognostic of thromboembolic complications associated with transvenous lead implantation.
More than 235.500 cardiac pacemakers and cardioverter-defibrillators are implanted in the US
every year, with an estimated 25,000 new implants in Brazil. Despite its proven clinical
effectiveness and efficacy for a number of clinical conditions such as arrhythmias, the
number of adverse events in the post-implant period remains substantial. Among these
complications, venous obstructions occurs anywhere between 14% and 64% of all patients,
causing devastating consequences such as upper extremity deep venous thrombosis and
pulmonary embolism, ultimately leading to either significant impairment or death. Although
retrospective studies have demonstrated the high incidence of these complications, as a
consequence of a paucity of reliable registries we know next to nothing regarding how these
venous lesions may influence the clinical outcome and mortality of patients, whether
laboratorial markers may contribute to the early diagnosis of venous thrombosis and its
complications, and about properties of diagnostic imaging for the identification of
thromboembolic complications after permanent transvenous leads implantation.
The objective of this study is therefore to propose a significant improvement in an existing
clinical database located within the Heart Institute (INCOR) at the University of Sao Paulo
to enable the provision of answers to a clinical, biomarker, and imaging-related research
questions. Specifically, our aims are to:
- Aim 1 - Registry infrastructure: In collaboration with professors from Duke University,
we will create a series of improvements to the current database to enable it to serve
as a platform not only for the current studies but also for future longitudinal,
randomized studies. These include the standardization of variables in accordance with
international guidelines, increase in patient retention and the ability to have
additional data points in-between clinical appointments, improvement in the
determination of cause of mortality, data quality monitoring, the creation of an item
bank to measure aspects of quality of life that are specific for this population, as
well as the integration of images and biomarkers to the clinical database.
- Aim 2 - Diagnostic imaging methods: To identify the incidence of upper extremity deep
venous thrombosis after cardiac devices implantations or reoperation procedures, as
well, the incidence of symptomatic and asymptomatic pulmonary thromboembolism.
- Aim 3 - Prognostic clinical factors: To study the impact of thromboembolic
complications in the clinical prognostic and mortality of patients;
- Aim 4 - Prognostic biomarkers: To determine the association between the biomarkers
related with alterations in the hemostasis system and the occurrence of venous
thrombosis (biomarkers: Fibrinogen, D Dimer, Antithrombin, Prothrombin fragment 1 +2,
thromboxane B, Platelets, Plasminogen)
At the end of this study we will have a registry with one of the largest number of patients
with this condition around the world, fully equipped for future randomized controlled
trials. We will also have a much better understanding regarding clinical, imaging, and
biomarkers for this condition.
;
Observational Model: Cohort, Time Perspective: Prospective
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