Metabolic SyndromeNCT04152395
Metabolic Syndrome in Patients Undergoing Endovascular Aortic Repair (EVAR)
An observational study of Metabolic Syndrome and Endovascular Aortic Repair, run by University of Thessaly.
Trial summary
This prospective study aims to identify the prevalence of metabolic syndrome in patients undergoing EVAR and the implications of metabolic syndrome on the postoperative outcome, the major complications, the thromboembolic events and the perioperative mortality and morbidity of the patients undergoing vascular surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Syndrome, Endovascular Aortic Repair
- What is being tested?
- EVAR
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 11 Dec 2022
- 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
- Adult, Older adult
Study population: Adult patients scheduled for elective EVAR
Who may be able to join
- elective EVAR
Who cannot join
- Patients incapable to give informed consent
- Pregnancy
- Cancer
- Systematic Inflammatory disease
- Use of steroids
- Emergency surgery
- Prior ICU admission
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Study of Metabolic Syndrome in Patients Undergoing Endovascular Aortic Repair (EVAR)
This prospective study aims to identify the prevalence of metabolic syndrome in patients undergoing EVAR and the implications of metabolic syndrome on the postoperative outcome, the major complications, the thromboembolic events and the perioperative mortality and morbidity of the patients undergoing vascular surgery.
Read the detailed description
Patients scheduled for elective EVAR will be randomly divided in two groups. One group patients with metabolic syndrome and one without.
Metabolic syndrome is defined by the definition of 2009 as:
Increased waist circumflex (>94 cm in men and > 80 cm in women), increased triglycerides or in therapy, decreased HDL (< 40 mg/dl in men and <50mg/dl in women) or in therapy, Increased blood pressure (Systolic Blood Pressure>130 mmHg or Diastolic Blood Pressure>85 mmHg) or in therapy, increased fasting glucose (>100mg/dl) or in therapy.
All the patients will be monitored throughout the perioperative period, at 30 days, 6 and 12 months, and any major or minor complication will be recorded.
- Conditions
- Metabolic Syndrome, Endovascular Aortic Repair
- Being tested
- EVAR
- Keywords
- Metabolic Syndrome, EVAR
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVAROther
Patients undergoing EVAR
| Study group | Role | What they receive |
|---|---|---|
| Metabolic group | Patients with metabolic syndrome undergoing EVAR Receives: Other: EVAR | |
| Control group | Patients without metabolic syndrome undergoing EVAR Receives: Other: EVAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Patients after EVAR who died in 30 days
Measured: 30 days
Mortality
Patients after EVAR who died in 6 months
Measured: 6 months
Mortality
Patients after EVAR who died in 12 months
Measured: 12 months
Secondary outcomes (18)
Systematic inflammatory response
Patients after EVAR that develop Systematic inflammatory response
Measured: 30 days
Systematic inflammatory response
Patients after EVAR that develop Systematic inflammatory response
Measured: 6 months
Systematic inflammatory response
Patients after EVAR that develop Systematic inflammatory response
Measured: 12 months
Postimplantation syndrome
Patients after EVAR that develop Postimplantation syndrome
Measured: 30 days
Postimplantation syndrome
Patients after EVAR that develop Postimplantation syndrome
Measured: 6 months
Postimplantation syndrome
Patients after EVAR that develop Postimplantation syndrome
Measured: 12 months
Renal insufficiency
Patients after EVAR that develop Renal insufficiency
Measured: 30 days
Renal insufficiency
Patients after EVAR that develop Renal insufficiency
Measured: 6 months
Renal insufficiency
Patients after EVAR that develop Renal insufficiency
Measured: 12 months
Cardiovascular events
Incidence of cardiovascular events in patients after EVAR
Measured: 30 days
Cardiovascular events
Incidence of cardiovascular events in patients after EVAR
Measured: 6 months
Cardiovascular events
Incidence of cardiovascular events in patients after EVAR
Measured: 12 months
Thromboembolic events
Incidence of thromboembolic events in patients after EVAR
Measured: 30 days
Thromboembolic events
Incidence of thromboembolic events in patients after EVAR
Measured: 6 months
Thromboembolic events
Incidence of thromboembolic events in patients after EVAR
Measured: 12 months
Complications of surgical procedure
Incidence of Complications of surgical procedure
Measured: 30 days
Complications of surgical procedure
Incidence of Complications of surgical procedure
Measured: 6 months
Complications of surgical procedure
Incidence of Complications of surgical procedure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start1 Jun 2020 (estimated)
- Primary completion11 Dec 2021 (estimated)
- Study completion11 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Arnaoutoglou, University of Thessaly
- Investigators
- Elena Arnaoutoglou, MD, PhD, Study chair, University of ThessalyHaralampos Milionis, MD, PhD, Study director, University of IoanninaKonstantina Kolonia, MD, PhD, Principal investigator, University Hospital of Larissa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152395
- Sponsor's protocol ID
- Metabolic syndrome in EVAR
- Status last verified
- May 2020
- First submitted
- 24 Sep 2019
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alberti KG, Eckel RH, Grundy SM, Zimmet PZ, Cleeman JI, Donato KA, Fruchart JC, James WP, Loria CM, Smith SC Jr; International Diabetes Federation Task Force on Epidemiology and Prevention; Hational Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; International Association for the Study of Obesity. Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation. 2009 Oct 20;120(16):1640-5. doi: 10.1161/CIRCULATIONAHA.109.192644. Epub 2009 Oct 5.
PubMed 19805654Alberti KG, Zimmet P, Shaw J; IDF Epidemiology Task Force Consensus Group. The metabolic syndrome--a new worldwide definition. Lancet. 2005 Sep 24-30;366(9491):1059-62. doi: 10.1016/S0140-6736(05)67402-8. No abstract available.
PubMed 16182882Grundy SM, Cleeman JI, Daniels SR, Donato KA, Eckel RH, Franklin BA, Gordon DJ, Krauss RM, Savage PJ, Smith SC Jr, Spertus JA, Fernando Costa. Diagnosis and management of the metabolic syndrome: an American Heart Association/National Heart, Lung, and Blood Institute scientific statement: Executive Summary. Crit Pathw Cardiol. 2005 Dec;4(4):198-203. doi: 10.1097/00132577-200512000-00018. No abstract available.
PubMed 18340209Aguilar M, Bhuket T, Torres S, Liu B, Wong RJ. Prevalence of the metabolic syndrome in the United States, 2003-2012. JAMA. 2015 May 19;313(19):1973-4. doi: 10.1001/jama.2015.4260. No abstract available.
PubMed 25988468
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Metabolic Syndrome in Patients Undergoing Endovascular Aortic Repair (EVAR)
- ClinicalTrials.gov ID
- NCT04152395
- Acronym / sponsor ID
- Metabolic syndrome in EVAR
- Conditions
- Metabolic Syndrome, Endovascular Aortic Repair
- Keywords
- Metabolic Syndrome, EVAR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 11 Dec 2021 (estimated)
- Study completion
- 11 Dec 2022 (estimated)
- First posted
- 5 Nov 2019 (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.
This prospective study aims to identify the prevalence of metabolic syndrome in patients undergoing EVAR and the implications of metabolic syndrome on the postoperative outcome, the major complications, the thromboembolic events and the perioperative mortality and morbidity of the patients undergoing vascular surgery.
Detailed description
Patients scheduled for elective EVAR will be randomly divided in two groups. One group patients with metabolic syndrome and one without.
Metabolic syndrome is defined by the definition of 2009 as:
Increased waist circumflex (>94 cm in men and > 80 cm in women), increased triglycerides or in therapy, decreased HDL (< 40 mg/dl in men and <50mg/dl in women) or in therapy, Increased blood pressure (Systolic Blood Pressure>130 mmHg or Diastolic Blood Pressure>85 mmHg) or in therapy, increased fasting glucose (>100mg/dl) or in therapy.
All the patients will be monitored throughout the perioperative period, at 30 days, 6 and 12 months, and any major or minor complication will be recorded.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metabolic group | – | Other: EVARPatients with metabolic syndrome undergoing EVAR |
| Control group | – | Other: EVARPatients without metabolic syndrome undergoing EVAR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients scheduled for elective EVAR
Key inclusion criteria (1 listed)
- elective EVAR
Key exclusion criteria (7 listed)
- Patients incapable to give informed consent
- Pregnancy
- Cancer
- Systematic Inflammatory disease
- Use of steroids
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 |
|---|---|---|
| EVARPatients undergoing EVAR | Other | Control group, Metabolic group |
Primary outcome
Mortality
Time frame: 30 days
Patients after EVAR who died in 30 days
Mortality
Time frame: 6 months
Patients after EVAR who died in 6 months
Mortality
Time frame: 12 months
Patients after EVAR who died in 12 months
18 secondary outcomes
Systematic inflammatory response
Time frame: 30 days
Systematic inflammatory response
Time frame: 6 months
Systematic inflammatory response
Time frame: 12 months
Postimplantation syndrome
Time frame: 30 days
Postimplantation syndrome
Time frame: 6 months
Postimplantation syndrome
Time frame: 12 months
Renal insufficiency
Time frame: 30 days
Renal insufficiency
Time frame: 6 months
Renal insufficiency
Time frame: 12 months
Cardiovascular events
Time frame: 30 days
Cardiovascular events
Time frame: 6 months
Cardiovascular events
Time frame: 12 months
Thromboembolic events
Time frame: 30 days
Thromboembolic events
Time frame: 6 months
Thromboembolic events
Time frame: 12 months
Complications of surgical procedure
Time frame: 30 days
Complications of surgical procedure
Time frame: 6 months
Complications of surgical procedure
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Results publication: PubMed 19805654Alberti KG, Eckel RH, Grundy SM, Zimmet PZ, Cleeman JI, Donato KA, Fruchart JC, James WP, Loria CM, Smith SC Jr; International Diabetes Federation Task Force on Epidemiology and Prevention; Hational Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; International Association for the Study of Obesity. Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation. 2009 Oct 20;120(16):1640-5. doi: 10.1161/CIRCULATIONAHA.109.192644. Epub 2009 Oct 5.
- Results publication: PubMed 16182882Alberti KG, Zimmet P, Shaw J; IDF Epidemiology Task Force Consensus Group. The metabolic syndrome--a new worldwide definition. Lancet. 2005 Sep 24-30;366(9491):1059-62. doi: 10.1016/S0140-6736(05)67402-8. No abstract available.
- Results publication: PubMed 18340209Grundy SM, Cleeman JI, Daniels SR, Donato KA, Eckel RH, Franklin BA, Gordon DJ, Krauss RM, Savage PJ, Smith SC Jr, Spertus JA, Fernando Costa. Diagnosis and management of the metabolic syndrome: an American Heart Association/National Heart, Lung, and Blood Institute scientific statement: Executive Summary. Crit Pathw Cardiol. 2005 Dec;4(4):198-203. doi: 10.1097/00132577-200512000-00018. No abstract available.
- Results publication: PubMed 25988468Aguilar M, Bhuket T, Torres S, Liu B, Wong RJ. Prevalence of the metabolic syndrome in the United States, 2003-2012. JAMA. 2015 May 19;313(19):1973-4. doi: 10.1001/jama.2015.4260. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Elena Arnaoutoglou, MD, PhD study chair
University of Thessaly
Haralampos Milionis, MD, PhD study director
University of Ioannina
Konstantina Kolonia, MD, PhD principal investigator
University Hospital of Larissa
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome and Endovascular Aortic Repair, run by University of Thessaly.
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: status not confirmed, as of the sponsor's last update on 27 May 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Konstantina Kolonia, MD (+306958261393, kon.kolonia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 30 days). The study lists 3 primary outcomes in all. 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 NCT04152395, which also lists 4 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 27 May 2020.