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The purpose of this study is to evaluate and monitor perioperative management of patients with coronary stents undergoing noncardiac surgery.
Objectives:
(Not desired)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coronary Stent | Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiac and Cerebrovascular Events (MACCEs) | Cardiac Mortality, Myocardial Infarction, Angina Pectoris, new arrythmia, Congestive Heart Failure, Stroke, Cardiac Arrest | up to 90 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Major Haemorrhagic Events | Transfusion > = 2 red blood cells Units, haemoglobin descent >= 20 gr/dL, intracerebral haemorrhage | up to 90 days after surgery |
| Number of Patients With Adverse Events Related With Antiplatelet Therapy Management |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with coronary stents undergoing noncardiac surgery with admission between May 2010 and April 2012
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| Name | Affiliation | Role |
|---|---|---|
| Anna Rodriguez-Pont, MD | Corporacio Sanitaria Parc Tauli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Germans Trias i Pujol | Badalona | Barcelona | Spain | |||
| Hospital Municipal de Badalona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29397139 | Derived | Rodriguez A, Guilera N, Mases A, Sierra P, Oliva JC, Colilles C; REGISTRESTENTS group. Management of antiplatelet therapy in patients with coronary stents undergoing noncardiac surgery: association with adverse events. Br J Anaesth. 2018 Jan;120(1):67-76. doi: 10.1016/j.bja.2017.11.012. Epub 2017 Nov 21. |
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Patients scheduled for noncardiac surgery with admission
Observational, multicenter and prospective study, approved by the Ethics Committee. All patients with coronary stents undergoing noncardiac surgery with admission from February 2010 to April 2012 were the basis of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Coronary Stent | Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
20 patienet were not taking previous antiplatelet agents
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| ID | Title | Description |
|---|---|---|
| BG000 | Coronary Stent | Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | age < or = 70 years old age > 70 years old |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Major Adverse Cardiac and Cerebrovascular Events (MACCEs) | Cardiac Mortality, Myocardial Infarction, Angina Pectoris, new arrythmia, Congestive Heart Failure, Stroke, Cardiac Arrest | Posted | Number | participants | up to 90 days after surgery |
|
|
Perioperative events from surgery to 90 days after
We registered the adverse events from surgery to 90 days after All the events were included in our outcomes definitions
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cardiac and Cerebrovascular Events | Adverse events registered independently related with antiplatelet therapy management |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Arrest | Cardiac disorders | Systematic Assessment | In hospital Cardiac arrest |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke, Transient Ischaemic Attack | Nervous system disorders | Systematic Assessment |
This is a prospective and observational study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anna Rodriguez-Pont | Corporacion Sanitaria y Universitaria Parc Tauli | 0034937231010 | 21283 | anna.r.pont@gmail.com |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
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Perioperative withdrawal antiplatelet therapy is defined with > or = 5 days without therapy
We create 3 categories:
| 90 days after surgery |
| Badalona |
| Barcelona |
| Spain |
| Fundació Puigvert - IUNA | Barcelona | Barcelona | Spain |
| Hospital ClÃnic | Barcelona | Barcelona | Spain |
| Parc de Salut Mar-Esperança | Barcelona | Barcelona | Spain |
| Parc de Salut Mar | Barcelona | Barcelona | Spain |
| Hospital Igualada | Igualada | Barcelona | Spain |
| Hospital de Mataró | Mataró | Barcelona | Spain |
| Hospital de Sabadell. Corporació Sanità ria Parc Taulà | Sabadell | Barcelona | 08208 | Spain |
| Hospital de Sant Celoni | Sant Celoni | Barcelona | Spain |
| ClÃnica ASEPEYO | Sant Cugat del Vallès | Barcelona | Spain |
| Hospital Sant Joan Despi Moisès Broggi | Sant Joan Despà | Barcelona | Spain |
| Hospital Mútua de Terrassa | Terrassa | Barcelona | 08221 | Spain |
| Number |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Median | Full Range | Kgm^2 |
|
| Antiplatelet Therapy | patients taking previous aspirin, clopidogrel or both | Number | participants |
|
|
| Secondary | Major Haemorrhagic Events | Transfusion > = 2 red blood cells Units, haemoglobin descent >= 20 gr/dL, intracerebral haemorrhage | Posted | Number | participants | up to 90 days after surgery |
|
|
|
| Secondary | Number of Patients With Adverse Events Related With Antiplatelet Therapy Management | Perioperative withdrawal antiplatelet therapy is defined with > or = 5 days without therapy We create 3 categories:
| MACCEs | Posted | Number | participants | 90 days after surgery |
|
|
|
|
| 61 |
| 432 |
| 6 |
| 432 |
| Cardiac Death | Cardiac disorders | Systematic Assessment | Death with cardiac origin |
|
| Acute Myocardial Infarction | Cardiac disorders | Systematic Assessment |
|
| Unstable Angina | Cardiac disorders | Systematic Assessment |
|
| Significant Arrythmia | Cardiac disorders | Systematic Assessment |
|
| Cardiac Failure | Cardiac disorders | Systematic Assessment |
|
| Deep Venous Thrombosis | Vascular disorders | Systematic Assessment |
|
| Arterial ischaemia | Vascular disorders | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| 0.479 |
| Odds Ratio (OR) |
| 1.638 |
| 2-Sided |
| 95 |
| 0.733 |
| 3.662 |
| No |
| Superiority or Other |