Acute Coronary SyndromeRegistStentsNCT01171612
Perioperative Management of Patients With Coronary Stents Undergoing Noncardiac Surgery
An observational study of Acute Coronary Syndrome and Coronary Stent Occlusion, run by Corporacion Parc Tauli at 13 sites in Spain.
Trial summary
The purpose of this study is to evaluate and monitor perioperative management of patients with coronary stents undergoing noncardiac surgery. Objectives: To describe the incidence and severity of adverse cardiovascular events in patients with coronary stents undergoing noncardiac surgery with admission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Coronary Stent Occlusion, Surgery
- How many people
- 483 participants
- Where
- 13 sitesSpain
- Study dates
- Jun 2009to Jul 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with coronary stents undergoing noncardiac surgery with admission between May 2010 and April 2012
Who may be able to join
- > 18 years old, with coronary stents
- American Society of Anaesthesia physical status II-V
- noncardiac surgery wiht admission
- informed consent
Who cannot join
- < 18 years old
- American Society of Anaesthesia physical status I
- ambulatory surgery
- pregnancy
- obstetric anaesthesia
- endoscopic procedures
- cardiac surgery
- not informed consent
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Spain13 sites
Hospital Germans Trias i Pujol
Badalona, Barcelona
Hospital Municipal de Badalona
Badalona, Barcelona
Fundació Puigvert - IUNA
Barcelona, Barcelona
Hospital Clínic
Barcelona, Barcelona
Parc de Salut Mar-Esperança
Barcelona, Barcelona
Parc de Salut Mar
Barcelona, Barcelona
Hospital Igualada
Igualada, Barcelona
Hospital de Mataró
Mataró, Barcelona
Hospital de Sabadell. Corporació Sanitària Parc Taulí
Sabadell, Barcelona, 08208
Hospital de Sant Celoni
Sant Celoni, Barcelona
Clínica ASEPEYO
Sant Cugat del Vallès, Barcelona
Hospital Sant Joan Despi Moisès Broggi
Sant Joan Despí, Barcelona
Hospital Mútua de Terrassa
Terrassa, Barcelona, 08221
About this study
Official title: Evaluation and Monitoring of Perioperative Management of Patients With Coronary Stents Undergoing Noncardiac Surgery
The purpose of this study is to evaluate and monitor perioperative management of patients with coronary stents undergoing noncardiac surgery.
Objectives:
- To describe the incidence and severity of adverse cardiovascular events in patients with coronary stents undergoing noncardiac surgery with admission.
- To assess the following-up of the guidelines about the perioperative management of antiplatelet therapy in these patients.
- To assess the relationship between the incidence of cardiac or neurovascular events, as well as bleeding complications with the perioperative management of antiplatelet therapy.
- Number of Participants with Adverse Events as a Measure of Safety
Read the detailed description
(Not desired)
- Conditions
- Acute Coronary Syndrome, Coronary Stent Occlusion, Surgery
- Keywords
- Coronary Stent, BMS stent, DES stent, Date of stent implantation, cardiac event, neurovascular event, Bleeding, transfusion
- Medical subject headings
- Acute Coronary Syndrome, Cardiovascular Diseases, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Coronary Stent | Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac and Cerebrovascular Events (MACCEs)
Cardiac Mortality, Myocardial Infarction, Angina Pectoris, new arrythmia, Congestive Heart Failure, Stroke, Cardiac Arrest
Measured: up to 90 days after surgery
Secondary outcomes (2)
Major Haemorrhagic Events
Transfusion > = 2 red blood cells Units, haemoglobin descent >= 20 gr/dL, intracerebral haemorrhage
Measured: up to 90 days after surgery
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:
- Not withdrawal
- Complete withdrawal (5 or > days without antiplatelet drugs , mono or dual therapy)
- Incomplete withdrawal: patients under dual antiplatelet therapy, who maintain aspirin and stopped clopidogrel =/ > 5 days
Measured: 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
- Study startJun 2009
- Primary completionFeb 2010
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies 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
- 483 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Rodriguez Pont, Corporacion Parc Tauli
- Investigators
- Anna Rodriguez-Pont, MD, Principal investigator, Corporacio Sanitaria Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171612
- Sponsor's protocol ID
- CIR2009017
- Acronym
- RegistStents
- Status last verified
- Mar 2016
- First submitted
- 23 Jul 2010
- Last updated
- 7 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 29397139
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Monitoring of Perioperative Management of Patients With Coronary Stents Undergoing Noncardiac Surgery
- ClinicalTrials.gov ID
- NCT01171612
- Acronym / sponsor ID
- RegistStents / CIR2009017
- Conditions
- Acute Coronary Syndrome, Coronary Stent Occlusion, Surgery
- Keywords
- Coronary Stent, BMS stent, DES stent, Date of stent implantation, cardiac event, neurovascular event, Bleeding, transfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 483 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 28 Jul 2010 (estimated)
- Results
- Posted 25 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate and monitor perioperative management of patients with coronary stents undergoing noncardiac surgery.
Objectives:
- To describe the incidence and severity of adverse cardiovascular events in patients with coronary stents undergoing noncardiac surgery with admission.
- To assess the following-up of the guidelines about the perioperative management of antiplatelet therapy in these patients.
- To assess the relationship between the incidence of cardiac or neurovascular events, as well as bleeding complications with the perioperative management of antiplatelet therapy.
- Number of Participants with Adverse Events as a Measure of Safety
Detailed description
(Not desired)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary Stent | – | –Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary stents undergoing noncardiac surgery with admission between May 2010 and April 2012
Key inclusion criteria (4 listed)
- > 18 years old, with coronary stents
- American Society of Anaesthesia physical status II-V
- noncardiac surgery wiht admission
- informed consent
Key exclusion criteria (8 listed)
- < 18 years old
- American Society of Anaesthesia physical status I
- ambulatory surgery
- pregnancy
- obstetric anaesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major Adverse Cardiac and Cerebrovascular Events (MACCEs)
Time frame: up to 90 days after surgery
Cardiac Mortality, Myocardial Infarction, Angina Pectoris, new arrythmia, Congestive Heart Failure, Stroke, Cardiac Arrest
2 secondary outcomes
Major Haemorrhagic Events
Time frame: up to 90 days after surgery
Number of Patients With Adverse Events Related With Antiplatelet Therapy Management
Time frame: 90 days after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29397139Rodriguez 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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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.
Anna Rodriguez-Pont, MD principal investigator
Corporacio Sanitaria Parc Tauli
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Coronary Stent Occlusion, run by Corporacion Parc Tauli at 13 sites in Spain.
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 4 inclusion and 8 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 7 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Spain. 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?
Yes. Results are posted in the registry (first posted 25 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Major Adverse Cardiac and Cerebrovascular Events (MACCEs) (time frame: up to 90 days after surgery). 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 NCT01171612, 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 7 Apr 2016.