Spontaneous Isolated Superior Mesenteric Artery DissectionNCT05342233
Comparison of Conservative and Endovascular Treatment for Spontaneously Isolated Superior Mesenteric Artery Dissection
An observational study of Spontaneous Isolated Superior Mesenteric Artery Dissection, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
Spontaneous isolated superior mesenteric artery dissection(SISMAD) is an increasingly diagnosed disease. However, prospective, multicenter studies that can provide evidence to support clinical decisions are very limited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spontaneous Isolated Superior Mesenteric Artery Dissection
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2022to 1 Apr 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 symptoms or history of isolated superior mesenteric artery dissection and confirmed by CTA.
Who may be able to join
- Aged 18 and above;
- Isolated superior mesenteric artery dissection with clear symptoms or history and confirmed by CTA
- Signed informed consent forms, willing to receive treatments
Who cannot join
- Symptoms are severe and patients need exploratory laparotomy;
- Patients with aortic dissection, iliac artery dissection, or autoimmune vasculitis;
- Patients with mental illness cannot cooperate subjectively;
- Patients who are allergic to contrast agents, or contraindicated to conservative treatment drugs, and cannot be treated with drugs;
- Pregnancy and breastfeeding women, or patients who have recent birth plans;
- Patients who are participating in other clinical projects;
- Patients are not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan
Wang Wei, 13808482650, weiwangcsu@csu.edu.cn
About this study
Official title: Comparison of Conservative and Endovascular Treatment for Spontaneously Isolated Superior Mesenteric Artery Dissection: A Real-world, Multicenter, Observational Study
Spontaneous isolated superior mesenteric artery dissection(SISMAD) is an increasingly diagnosed disease. However, prospective, multicenter studies that can provide evidence to support clinical decisions are very limited. This study aims to compare the therapeutic efficacy of conservative and endovascular treatment for SISMAD.
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 |
|---|---|---|
| Endovascular treatment Group | Patients receiving endovascular treatments | |
| Conservative treatment Group | Patients receiving conservative treatments, including blood pressure control, bowel rest, antithrombotic therapy, nutrition treatment and pain management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality during follow-up period
Measured: up to 5 years
Rate of symptom relief
Rate of symptom relief during follow-up period
Measured: up to 5 years
Secondary outcomes (4)
Reintervention rate
Reintervention related to SISMAD after treatments during follow-up period
Measured: Follow-up period（ 5 years）
Recurrence rate
SISMAD Recurrence after treatments during follow-up period
Measured: Follow-up period（5 years）
Disease-related complications
Disease-related complications after treatments during follow-up period
Measured: Follow-up period（5 years）
Complete remodeling rate of superior mesenteric artery dissection
Complete remodeling rate of superior mesenteric artery dissection after receiving different treatments
Measured: Follow-up period（5 years）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start30 Apr 2022 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous Isolated Superior Mesenteric Artery DissectionStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe 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
- 200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- The First Medical Center of Chinese PLA General Hospital, West China Hospital, Renmin Hospital of Wuhan University, Peking University Shenzhen Hospital, Affiliated Hospital of Chengde Medical University, Second Affiliated Hospital of Nanchang University, Henan Provincial People's Hospital, The Affiliated Hospital of Inner Mongolia Medical University
- Responsible party
- Principal investigator, xueguanwaike, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342233
- Sponsor's protocol ID
- ISMAD2022
- Status last verified
- Apr 2022
- First submitted
- 10 Apr 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conservative and Endovascular Treatment for Spontaneously Isolated Superior Mesenteric Artery Dissection: A Real-world, Multicenter, Observational Study
- ClinicalTrials.gov ID
- NCT05342233
- Acronym / sponsor ID
- ISMAD2022
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- The First Medical Center of Chinese PLA General Hospital, West China Hospital, Renmin Hospital of Wuhan University, Peking University Shenzhen Hospital, Affiliated Hospital of Chengde Medical University, Second Affiliated Hospital of Nanchang University, Henan Provincial People's Hospital, The Affiliated Hospital of Inner Mongolia Medical University
- Study start
- 30 Apr 2022 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 22 Apr 2022 (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.
Spontaneous isolated superior mesenteric artery dissection(SISMAD) is an increasingly diagnosed disease. However, prospective, multicenter studies that can provide evidence to support clinical decisions are very limited. This study aims to compare the therapeutic efficacy of conservative and endovascular treatment for SISMAD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovascular treatment Group | – | –Patients receiving endovascular treatments |
| Conservative treatment Group | – | –Patients receiving conservative treatments, including blood pressure control, bowel rest, antithrombotic therapy, nutrition treatment and pain management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptoms or history of isolated superior mesenteric artery dissection and confirmed by CTA.
Key inclusion criteria (3 listed)
- Aged 18 and above;
- Isolated superior mesenteric artery dissection with clear symptoms or history and confirmed by CTA
- Signed informed consent forms, willing to receive treatments
Key exclusion criteria (7 listed)
- Symptoms are severe and patients need exploratory laparotomy;
- Patients with aortic dissection, iliac artery dissection, or autoimmune vasculitis;
- Patients with mental illness cannot cooperate subjectively;
- Patients who are allergic to contrast agents, or contraindicated to conservative treatment drugs, and cannot be treated with drugs;
- Pregnancy and breastfeeding women, or patients who have recent birth plans;
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
Mortality
Time frame: up to 5 years
Mortality during follow-up period
Rate of symptom relief
Time frame: up to 5 years
Rate of symptom relief during follow-up period
4 secondary outcomes
Reintervention rate
Time frame: Follow-up period（ 5 years）
Recurrence rate
Time frame: Follow-up period（5 years）
Disease-related complications
Time frame: Follow-up period（5 years）
Complete remodeling rate of superior mesenteric artery dissection
Time frame: Follow-up period（5 years）
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spontaneous Isolated Superior Mesenteric Artery Dissection, run by Xiangya Hospital of Central South University at 1 site in China.
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 3 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: looking for participants now, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wang WEI, Ph.D. (13808482650, weiwangcsu@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: up to 5 years). The study lists 2 primary outcomes in all. 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 22 Apr 2022.