Aortic DissectionNCT02523300
Glucocorticoid on the Prognosis of TEVAR
A study testing TEVAR, Glucocorticoids and saline in people with Aortic Dissection, run by Changhai Hospital.
Trial summary
To explore the potential prognostic effect of glucocorticoid on the postoperative aorta-related adverse events after aortic dissections patients underwent thoracic endovascular aortic repair (TEVAR), glucocorticoid (30mg/kg) will be intravenously given within 2h after TEVAR. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aortic Dissection
- What is being tested?
- TEVAR, Glucocorticoids and saline
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Sep 2019
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age from 18 to 80, male or unpregnant female;
- diagnosed as aortic dissection, excluding intramural hematoma and penetrating aortic ulcer;
- complicated aortic dissection with definite indications of TEVAR;
- voluntarily signed the informed consent form;
- good compliance with the instructions and cooperate with follow-up.
Who cannot join
- no appropriate vessel approaches;
- patients with connective tissue diseases (such as Marfan syndrome);
- patients with endocrine disease,such as diabetes mellitus, or undergoing hormonotherapy;
- bad compliance with the instructions and follow-up;
- allergic to nitinol and contrast medium;
- estimated life expectancy is less than 24 months.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prognostic Value of Single-dose Glucocorticoid After Endovascular Repair for Aortic Dissection
To explore the potential prognostic effect of glucocorticoid on the postoperative aorta-related adverse events after aortic dissections patients underwent thoracic endovascular aortic repair (TEVAR), glucocorticoid (30mg/kg) will be intravenously given within 2h after TEVAR.
Read the detailed description
This is a prospective, open, single-center, randomized controlled trial. Number of patients: 240 patients will be included and undertaken TEVAR.About 120 patients will be given glucocorticoid within 2h after TEVAR as experimental group, and the other 120 patients will be given saline as control group.
Follow-up: 1. aortic computed tomographic angiography (CTA) examination 6, 12 and 24 months after TEVAR; 2. telephone or clinical follow-up at 1, 2, 3, 6, 12 and 24 months.
Primary outcome measure: aorta-related adverse events. Second outcome measure: 30-day mortality after TEVAR, success rate of endovascular repair, drug-related adverse events.
- Conditions
- Aortic Dissection
- Being tested
- TEVAR, Glucocorticoids, saline
- Medical subject headings
- Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEVARProcedure or surgery
Also called thoracic endovascular aortic repair
The patients will be undertaken TEVAR
GlucocorticoidsDrug
Also called methylprednisolone
About 120 patients will be given glucocorticoids within 2h after TEVAR as experimental group
salineDrug
Also called Vehicle
The other 120 patients will be given saline as control group
| Study group | Role | What they receive |
|---|---|---|
| TEVAR+GC | Experimental | The patients underwent TEVAR. Then glucocorticoids will be intravenously given after TEVAR Receives: Procedure: TEVAR; Drug: Glucocorticoids |
| TEVAR+Vehicle | Placebo comparator | The patients underwent TEVAR. Then saline will be given after TEVAR Receives: Procedure: TEVAR; Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aorta-related adverse events
Measured: 24 months
Secondary outcomes (3)
30-day mortality after TEVAR
Measured: 30 days
Success rate of endovascular repair
Measured: 24 months
Drug-related adverse events
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startOct 2015
- Primary completionSep 2017 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic DissectionStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zaiping JING, Changhai Hospital
- Investigators
- Zaiping Jing, Doctor, Principal investigator, Department of Vascular Surgery, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523300
- Sponsor's protocol ID
- GC-AD-2015-07
- Status last verified
- Aug 2015
- First submitted
- 11 Aug 2015
- Last updated
- 14 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wu M, Zhang L, Bao J, Zhao Z, Lu Q, Feng R, Song C, Zhou J, Jing Z. Postoperative glucocorticoid enhances recovery after endovascular aortic repair for chronic type B aortic dissection: a single-center experience. BMC Cardiovasc Disord. 2016 Mar 25;16:59. doi: 10.1186/s12872-016-0234-2.
PubMed 27013022
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Single-dose Glucocorticoid After Endovascular Repair for Aortic Dissection
- ClinicalTrials.gov ID
- NCT02523300
- Acronym / sponsor ID
- GC-AD-2015-07
- Conditions
- Aortic Dissection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 14 Aug 2015 (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.
To explore the potential prognostic effect of glucocorticoid on the postoperative aorta-related adverse events after aortic dissections patients underwent thoracic endovascular aortic repair (TEVAR), glucocorticoid (30mg/kg) will be intravenously given within 2h after TEVAR.
Detailed description
This is a prospective, open, single-center, randomized controlled trial. Number of patients: 240 patients will be included and undertaken TEVAR.About 120 patients will be given glucocorticoid within 2h after TEVAR as experimental group, and the other 120 patients will be given saline as control group.
Follow-up: 1. aortic computed tomographic angiography (CTA) examination 6, 12 and 24 months after TEVAR; 2. telephone or clinical follow-up at 1, 2, 3, 6, 12 and 24 months.
Primary outcome measure: aorta-related adverse events. Second outcome measure: 30-day mortality after TEVAR, success rate of endovascular repair, drug-related adverse events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEVAR+GC | Experimental | Procedure: TEVAR, Drug: GlucocorticoidsThe patients underwent TEVAR. Then glucocorticoids will be intravenously given after TEVAR |
| TEVAR+Vehicle | Placebo comparator | Procedure: TEVAR, Drug: salineThe patients underwent TEVAR. Then saline will be given after TEVAR |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age from 18 to 80, male or unpregnant female;
- diagnosed as aortic dissection, excluding intramural hematoma and penetrating aortic ulcer;
- complicated aortic dissection with definite indications of TEVAR;
- voluntarily signed the informed consent form;
- good compliance with the instructions and cooperate with follow-up.
Key exclusion criteria (6 listed)
- no appropriate vessel approaches;
- patients with connective tissue diseases (such as Marfan syndrome);
- patients with endocrine disease,such as diabetes mellitus, or undergoing hormonotherapy;
- bad compliance with the instructions and follow-up;
- allergic to nitinol and contrast medium;
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 |
|---|---|---|
| TEVARAlso: thoracic endovascular aortic repairThe patients will be undertaken TEVAR | Procedure or surgery | TEVAR+GC, TEVAR+Vehicle |
| GlucocorticoidsAlso: methylprednisoloneAbout 120 patients will be given glucocorticoids within 2h after TEVAR as experimental group | Drug | TEVAR+GC |
| salineAlso: VehicleThe other 120 patients will be given saline as control group | Drug | TEVAR+Vehicle |
Primary outcome
Aorta-related adverse events
Time frame: 24 months
3 secondary outcomes
30-day mortality after TEVAR
Time frame: 30 days
Success rate of endovascular repair
Time frame: 24 months
Drug-related adverse events
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2015.
- Derived from this study: PubMed 27013022Wu M, Zhang L, Bao J, Zhao Z, Lu Q, Feng R, Song C, Zhou J, Jing Z. Postoperative glucocorticoid enhances recovery after endovascular aortic repair for chronic type B aortic dissection: a single-center experience. BMC Cardiovasc Disord. 2016 Mar 25;16:59. doi: 10.1186/s12872-016-0234-2.
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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.
Zaiping Jing, Doctor principal investigator
Department of Vascular Surgery, Changhai Hospital
Questions about this trial
What is this clinical trial studying?
A study testing TEVAR, Glucocorticoids and saline in people with Aortic Dissection, run by Changhai Hospital.
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 5 inclusion and 6 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 14 Aug 2015. 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. Some participants in this study may receive a placebo. 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 Jian Zhou, Doctor (86-21-31161669, zhoujian1-2@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aorta-related adverse events (time frame: 24 months). 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 NCT02523300, 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 14 Aug 2015.