Comparison of Conservative and Endovascular Treatment for Spontaneously Isolated Superior Mesenteric Artery Dissection

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.

Study Overview

• Status: Recruiting
• Conditions: Spontaneous Isolated Superior Mesenteric Artery Dissection

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Wang WEI, Ph.D.; Phone Number: 13808482650; Email: weiwangcsu@csu.edu.cn

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Xiangya Hospital of Central South University
      • Contact: Wang Wei; Phone Number: 13808482650; Email: weiwangcsu@csu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with symptoms or history of isolated superior mesenteric artery dissection and confirmed by CTA.

Description

Inclusion Criteria:

1. Aged 18 and above;
2. Isolated superior mesenteric artery dissection with clear symptoms or history and confirmed by CTA
3. Signed informed consent forms, willing to receive treatments

Exclusion Criteria:

1. Symptoms are severe and patients need exploratory laparotomy;
2. Patients with aortic dissection, iliac artery dissection, or autoimmune vasculitis;
3. Patients with mental illness cannot cooperate subjectively;
4. Patients who are allergic to contrast agents, or contraindicated to conservative treatment drugs, and cannot be treated with drugs;
5. Pregnancy and breastfeeding women, or patients who have recent birth plans;
6. Patients who are participating in other clinical projects;
7. Patients are not suitable to participate in this study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality during follow-up period	up to 5 years
Rate of symptom relief	Rate of symptom relief during follow-up period	up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reintervention rate	Reintervention related to SISMAD after treatments during follow-up period	Follow-up period（ 5 years）
Recurrence rate	SISMAD Recurrence after treatments during follow-up period	Follow-up period（5 years）
Disease-related complications	Disease-related complications after treatments during follow-up period	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	Follow-up period（5 years）

Collaborators and Investigators

• Sponsor: Xiangya Hospital of Central South University
• Collaborators: West China Hospital; Henan Provincial People's Hospital; Renmin Hospital of Wuhan University; Peking University Shenzhen Hospital; Second Affiliated Hospital of Nanchang University; The Affiliated Hospital of Inner Mongolia Medical University; Affiliated Hospital of Chengde Medical University; The First Medical Center of Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 30, 2022
• Primary Completion (Anticipated): April 1, 2027
• Study Completion (Anticipated): April 1, 2028

Study Registration Dates

• First Submitted: April 10, 2022
• First Submitted That Met QC Criteria: April 15, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 15, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting
• Other Study ID Numbers: ISMAD2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No