Aortic Aneurysm, AbdominalCCVSNCT03188341
Cardiac Complication After Vascular Surgery
An observational study of Aortic Aneurysm, Abdominal and Ventricular Arrythmia, run by Pomeranian Medical University Szczecin.
Trial summary
The vascular surgery is a highest risk procedure when considering postoperative complications associated with the cardiovascular system. The leading clinical presentation is acute hemodynamic decompensation. However, one of the possible pathomechanisms might be repolarization disturbances. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Abdominal, Ventricular Arrythmia, Peripheral Arterial Disease
- What is being tested?
- vascular surgery procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to Jun 2017
- 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: Adult patients diagnosed with abdominal subrenal aortic aneurysms or peripheral arterial disease scheduled for an elective "open" vascular surgery procedure. The study was conducted by the team from Department of Anaesthesiology, Intensive Care and Acute Poisoning of the tertiary teaching hospital at the Pomeranian Medical University in Szczecin, Poland.
Who may be able to join
- adult patients diagnosed with abdominal subrenal aortic aneurysms or peripheral arterial disease scheduled for an elective "open" vascular surgery procedure
Who cannot join
- heart stimulation,
- atrioventricular and intraventricular conduction defects,
- atrial fibrillation recorded before of the study,
- antiarrhythmic drug treatment (except beta-blockers),
- unoptimal patient general status (uncontrolled diabetes, active infection)
- reoperation
- emergency operations
About this study
Official title: The Reasons of Repolarization Disturbances Disclosure in Vascular Surgery
The vascular surgery is a highest risk procedure when considering postoperative complications associated with the cardiovascular system. The leading clinical presentation is acute hemodynamic decompensation. However, one of the possible pathomechanisms might be repolarization disturbances. Many of perioperative risk factors of cardiac complications are modifiable. The identification may help in the global perioperative risk reduction.
Aim: The aim of the study was an identification of the factors which may release clinically overt repolarization disturbances.
Methods: The study group consisted of 100 patients, diagnosed with abdominal subrenal aortic aneurysms or peripheral arterial disease scheduled for an elective "open" vascular surgery procedure. The authors investigated whether age, gender, comorbidities or some perioperative factors (including hemodynamic, metabolic or genetic) were related to the occurrence of clinically concealed repolarization disturbances or clinically disclosed cardiac complications in postoperative time up to 30 day and one year after vascular surgery procedure.
Read the detailed description
Vascular surgery is thought as the highest risk procedure in the context of cardiac complications. The range may include acute coronary syndrome, acute circulatory failure, severe arrhythmias, syncope and sudden cardiac death. The patient population is considered as a high risk, too. Popular calculators used for risk stratifications are based on preoperative patient's history and some general laboratory results. However, general status of the patient changes dynamically during vascular procedures leading to acquired increased risk. For this reason, sole preoperative risk prediction based on standard calculators is unsuitable and suboptimal. Advanced monitoring systems may record some temporary disturbances (e.g. ventricular repolarization disturbances), which may be asymptomatic. The clinical significance in postoperative risk prediction of such observations remains undefined. On the other hand, many of perioperative cardiac complications are caused by modifiable factors. The identification may help in the global perioperative risk reduction.
- Conditions
- Aortic Aneurysm, Abdominal, Ventricular Arrythmia, Peripheral Arterial Disease, Cardiac Complication
- Being tested
- vascular surgery procedure
- Keywords
- vascular surgery, repolarization disturbances, cardiac complications, high risk patient, high risk procedure
- Medical subject headings
- Aortic Aneurysm, Abdominal, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vascular surgery procedureOther
- an elective "open" vascular surgery procedure
- ECG Holter recording during the procedure and 24 hours after operation (continuous electrocardiographic tracing (digital Holter ECG monitor)
| Study group | Role | What they receive |
|---|---|---|
| vascular surgery patients | * clinically concealed repolarization disturbances during vascular surgery procedure
* clinically disclosed cardiac complications during and after vascular surgery procedure Receives: Other: vascular surgery procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac complications
cardiac complications according to European Society of Cardiology
Measured: up to 30 days after vascular procedure
Secondary outcomes (2)
cardiac complications
cardiac complications according to European Society of Cardiology
Measured: during surgical procedure
cardiac complications
cardiac complications according to European Society of Cardiology
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study startDec 2010
- Primary completionDec 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm, AbdominalStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jowita Biernawska, Pomeranian Medical University Szczecin
- Investigators
- Jowita Biernawska, MD, PhD, Principal investigator, Department of Anaesthesiology and Intensive Care of the Pomeranian Medical University in Szczecin, Poland.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188341
- Sponsor's protocol ID
- PomeranianMU
- Acronym
- CCVS
- Status last verified
- Jun 2017
- First submitted
- 8 Jun 2017
- Last updated
- 15 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reasons of Repolarization Disturbances Disclosure in Vascular Surgery
- ClinicalTrials.gov ID
- NCT03188341
- Acronym / sponsor ID
- CCVS / PomeranianMU
- Conditions
- Aortic Aneurysm, Abdominal, Ventricular Arrythmia, Peripheral Arterial Disease, Cardiac Complication
- Keywords
- vascular surgery, repolarization disturbances, cardiac complications, high risk patient, high risk procedure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- Dec 2010 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 15 Jun 2017 (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 vascular surgery is a highest risk procedure when considering postoperative complications associated with the cardiovascular system. The leading clinical presentation is acute hemodynamic decompensation. However, one of the possible pathomechanisms might be repolarization disturbances. Many of perioperative risk factors of cardiac complications are modifiable. The identification may help in the global perioperative risk reduction.
Aim: The aim of the study was an identification of the factors which may release clinically overt repolarization disturbances.
Methods: The study group consisted of 100 patients, diagnosed with abdominal subrenal aortic aneurysms or peripheral arterial disease scheduled for an elective "open" vascular surgery procedure. The authors investigated whether age, gender, comorbidities or some perioperative factors (including hemodynamic, metabolic or genetic) were related to the occurrence of clinically concealed repolarization disturbances or clinically disclosed cardiac complications in postoperative time up to 30 day and one year after vascular surgery procedure.
Detailed description
Vascular surgery is thought as the highest risk procedure in the context of cardiac complications. The range may include acute coronary syndrome, acute circulatory failure, severe arrhythmias, syncope and sudden cardiac death. The patient population is considered as a high risk, too. Popular calculators used for risk stratifications are based on preoperative patient's history and some general laboratory results. However, general status of the patient changes dynamically during vascular procedures leading to acquired increased risk. For this reason, sole preoperative risk prediction based on standard calculators is unsuitable and suboptimal. Advanced monitoring systems may record some temporary disturbances (e.g. ventricular repolarization disturbances), which may be asymptomatic. The clinical significance in postoperative risk prediction of such observations remains undefined. On the other hand, many of perioperative cardiac complications are caused by modifiable factors. The identification may help in the global perioperative risk reduction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vascular surgery patients | – | Other: vascular surgery procedure* clinically concealed repolarization disturbances during vascular surgery procedure * clinically disclosed cardiac complications during and after vascular surgery procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with abdominal subrenal aortic aneurysms or peripheral arterial disease scheduled for an elective "open" vascular surgery procedure. The study was conducted by the team from Department of Anaesthesiology, Intensive Care and Acute Poisoning of the tertiary teaching hospital at the Pomeranian Medical University in Szczecin, Poland.
Key inclusion criteria (1 listed)
- adult patients diagnosed with abdominal subrenal aortic aneurysms or peripheral arterial disease scheduled for an elective "open" vascular surgery procedure
Key exclusion criteria (7 listed)
- heart stimulation,
- atrioventricular and intraventricular conduction defects,
- atrial fibrillation recorded before of the study,
- antiarrhythmic drug treatment (except beta-blockers),
- unoptimal patient general status (uncontrolled diabetes, active infection)
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 |
|---|---|---|
| vascular surgery procedure* an elective "open" vascular surgery procedure * ECG Holter recording during the procedure and 24 hours after operation (continuous electrocardiographic tracing (digital Holter ECG monitor) | Other | vascular surgery patients |
Primary outcome
cardiac complications
Time frame: up to 30 days after vascular procedure
cardiac complications according to European Society of Cardiology
2 secondary outcomes
cardiac complications
Time frame: during surgical procedure
cardiac complications
Time frame: one year
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 15 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Jowita Biernawska, MD, PhD principal investigator
Department of Anaesthesiology and Intensive Care of the Pomeranian Medical University in Szczecin, Poland.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Aneurysm, Abdominal and Ventricular Arrythmia, run by Pomeranian Medical University Szczecin.
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 1 inclusion and 7 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 15 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
cardiac complications (time frame: up to 30 days after vascular procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2017.