Cardiovascular ComplicationsRECONCT01045850
Prospective Cohort of Patient With Coronary Stents Undergoing Non Cardiac Surgery
An observational study of Cardiovascular Complications and Hemorrhagic Complications, run by University Hospital, Grenoble at 53 sites in France.
Trial summary
Non cardiac surgery in patients with coronary stents is complicated with cardiovascular and hemorrhagic events associated with perioperative management of antiplatelet agents. Several guidelines have outlined the importance of maintaining antiplatelet agents throughout surgical procedures to prevent cardiovascular… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Complications, Hemorrhagic Complications
- How many people
- 1,312 participants
- Where
- 53 sitesFrance
- Study dates
- Feb 2006to Jan 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with coronary stents undergoing non cardiac surgery or invasive procedures
Who may be able to join
- 18 years old or more
- patient requiring a non cardiac surgery
- patient with a coronary stent
- patient agree for personal health data collection and analysis
Who cannot join
- patient less than 18 years
- patient unable to understand
Trial locations and contacts
53 sites in 1 country.
53 sites in 1 country
France53 sites
HOSPITAL
Aix-en-Provence
HOSPITAL
Albi
HOSPITAL
Amiens
HOSPITAL
Angers
HOSPITAL
Avignon
HOSPITAL
Beaumont
HOSPITAL
Berck
HOSPITAL
Besançon
HOSPITAL
Bordeaux
HOSPITAL
Cabestany
HOSPITAL
Castres
HOSPITAL
Cavaillon
HOSPITAL
Chalon En Champagne
HOSPITAL
Chenôve
HOSPITAL
Clermont-Ferrand
HOSPITAL
Cornebarrieu
HOSPITAL
Dracy-le-Fort
HOSPITAL
Équeurdreville-Hainneville
HOSPITAL
Grenoble
HOSPITAL
Hyères
HOSPITAL
Istres
HOSPITAL
La Roche-sur-Yon
HOSPITAL
La Rochelle
HOSPITAL
La Seyne-sur-Mer
HOSPITAL
Le Mans
HOSPITAL
Lyon
HOSPITAL
Manosque
HOSPITAL
Mantes-la-Jolie
HOSPITAL
Marseille
HOSPITAL
Maubeuge
HOSPITAL
Metz
HOSPITAL
Montpellier
HOSPITAL
Mulhouse
HOSPITAL
Nancy
HOSPITAL
Nantes
HOSPITAL
Nice
HOSPITAL
Niort
HOSPITAL
Paris
HOSPITAL
Perpignan
HOSPITAL
Pierre-Bénite
HOSPITAL
Redon
HOSPITAL
Rennes
HOSPITAL
Romans
HOSPITAL
Rouen
HOSPITAL
Saint-Denis
HOSPITAL
Saint-Dizier
HOSPITAL
Saint-Etienne
HOSPITAL
Saint-Herblain
HOSPITAL
St-Malo
HOSPITAL
Toulouse
HOSPITAL
Trélazé
HOSPITAL
Villeneuve-sur-Lot
HOSPITAL
Voiron
About this study
Official title: Multicenter, Prospective Cohort of Patient With Coronary Stents Undergoing Non Cardiac Surgery or Invasive Procedures.
Non cardiac surgery in patients with coronary stents is complicated with cardiovascular and hemorrhagic events associated with perioperative management of antiplatelet agents. Several guidelines have outlined the importance of maintaining antiplatelet agents throughout surgical procedures to prevent cardiovascular complications. On the other hand, interruption of antiplatelet agents is still a usual standard to avoid surgical complications. We investigate the impact of perioperative antiplatelet drugs management on these complications, through a multicenter, prospective cohort (RECO stands for "Registre des patients porteurs d'Endoprothèses Coronaires, Opérés de chirurgie non cardiaque"), including all patients with coronary stents undergoing non cardiac surgery or invasive procedures. The aim of this study is primarily to measure the incidence of cardiovascular (including stent thrombosis) and hemorrhagic complications and to identify pre and postoperative risk factors associated with these complications.
- Keywords
- coronary stents, non cardiac surgery, cardiovascular complications, hemorrhagic complications, antiplatelet agents, bare metal stent, drug eluting stent, surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite cardiovascular and hemorrhagic postoperative complications
Measured: 30 days
Secondary outcomes (1)
Postoperative death
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2010 (estimated)
- Study startFeb 2006
- Primary completionJun 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular ComplicationsStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- 1,312 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Investigators
- Pierre ALBALADEJO, MD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045850
- Sponsor's protocol ID
- DTCIC-09-29
- Other IDs
- CFAR
- Acronym
- RECO
- Status last verified
- Jan 2010
- First submitted
- 7 Jan 2010
- Last updated
- 13 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Albaladejo P, Charbonneau H, Samama CM, Collet JP, Marret E, Piriou V, Genty C, Bosson JL. Bleeding complications in patients with coronary stents during non-cardiac surgery. Thromb Res. 2014 Aug;134(2):268-72. doi: 10.1016/j.thromres.2014.05.015. Epub 2014 May 15.
PubMed 24913999Albaladejo P, Marret E, Samama CM, Collet JP, Abhay K, Loutrel O, Charbonneau H, Jaber S, Thoret S, Bosson JL, Piriou V. Non-cardiac surgery in patients with coronary stents: the RECO study. Heart. 2011 Oct;97(19):1566-72. doi: 10.1136/hrt.2011.224519. Epub 2011 Jul 26.
PubMed 21791513
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective Cohort of Patient With Coronary Stents Undergoing Non Cardiac Surgery or Invasive Procedures.
- ClinicalTrials.gov ID
- NCT01045850
- Acronym / sponsor ID
- RECO / DTCIC-09-29
- Keywords
- coronary stents, non cardiac surgery, cardiovascular complications, hemorrhagic complications, antiplatelet agents, bare metal stent, drug eluting stent, surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,312 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 11 Jan 2010 (estimated)
- 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.
Non cardiac surgery in patients with coronary stents is complicated with cardiovascular and hemorrhagic events associated with perioperative management of antiplatelet agents. Several guidelines have outlined the importance of maintaining antiplatelet agents throughout surgical procedures to prevent cardiovascular complications. On the other hand, interruption of antiplatelet agents is still a usual standard to avoid surgical complications. We investigate the impact of perioperative antiplatelet drugs management on these complications, through a multicenter, prospective cohort (RECO stands for "Registre des patients porteurs d'Endoprothèses Coronaires, Opérés de chirurgie non cardiaque"), including all patients with coronary stents undergoing non cardiac surgery or invasive procedures. The aim of this study is primarily to measure the incidence of cardiovascular (including stent thrombosis) and hemorrhagic complications and to identify pre and postoperative risk factors associated with these complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
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 non cardiac surgery or invasive procedures
Key inclusion criteria (4 listed)
- 18 years old or more
- patient requiring a non cardiac surgery
- patient with a coronary stent
- patient agree for personal health data collection and analysis
Key exclusion criteria (2 listed)
- patient less than 18 years
- patient unable to understand
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
Composite cardiovascular and hemorrhagic postoperative complications
Time frame: 30 days
1 secondary outcome
Postoperative death
Time frame: 30 days
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 13 Jan 2010.
- Derived from this study: PubMed 24913999Albaladejo P, Charbonneau H, Samama CM, Collet JP, Marret E, Piriou V, Genty C, Bosson JL. Bleeding complications in patients with coronary stents during non-cardiac surgery. Thromb Res. 2014 Aug;134(2):268-72. doi: 10.1016/j.thromres.2014.05.015. Epub 2014 May 15.
- Derived from this study: PubMed 21791513Albaladejo P, Marret E, Samama CM, Collet JP, Abhay K, Loutrel O, Charbonneau H, Jaber S, Thoret S, Bosson JL, Piriou V. Non-cardiac surgery in patients with coronary stents: the RECO study. Heart. 2011 Oct;97(19):1566-72. doi: 10.1136/hrt.2011.224519. Epub 2011 Jul 26.
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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.
Pierre ALBALADEJO, MD principal investigator
University Hospital, Grenoble
53 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Complications and Hemorrhagic Complications, run by University Hospital, Grenoble at 53 sites in France.
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 2 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 13 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in France. 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?
Composite cardiovascular and hemorrhagic postoperative complications (time frame: 30 days). 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 NCT01045850, which also lists 2 linked publications.
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 13 Jan 2010.