Optimized Strategies for Malperfusion Syndrome

Optimized Strategies for Acute Type A Aortic Dissection Complicated With MalPerfusion Syndrome (OPTIMIZE-MPS)

An investigator-initiated, randomized, multicenter, two-arm, open-label study of consecutive patients presenting with acute type A aortic dissection (ATAAD) and malperfusion syndrome (MPS).

Objectives: The present study aimed to investigate the difference in all-cause mortality after optimized treatment strategies (OTS) versus traditional treatment strategies (TTS) for ATAAD patients with MPS.

Background: The mortality of ATAAD with MPS is high. However, the management strategies of MPS patients still not to be confirmed. Compare with TTS, OTS as a strategy for ATAAD patients with MPS might have be beneficial results.

Study Overview

• Status: Not yet recruiting
• Conditions: Aortic Dissection
• Intervention / Treatment: Procedure: Optimized treatment strategies; Procedure: Traditional treatment strategies

Detailed Description

A total of 236 subjects with ATAAD complicated with MPS who met inclusion criteria and do not have any exclusion criterion will be randomized to optimized treatment strategies (OTS) group and traditional treatment strategies (TTS) group.

1. Patients randomized to OTS group will be treated with optimized treatment strategies. The optimized strategies based on 6-hour threshold from symptom onset. For malperfused patients with symptom onset within 6 hours, central repair will be performed immediately. Additional stenting will be used in patients with persistent malperfusion. For malperfused patients with symptom onset beyond 6 hours, individualized delayed central repair according to the different types of MPS will be performed after organ function improved and the patient could tolerate central repair.
2. Patients randomized to TTS group will treated with traditional treatment strategies. Immediate central repair will performed for patients with coronary and cerebral malperfusion syndrome. However, for patients with mesenteric and lower extremity malperfusion syndrome, interventional therapy will be administered through fenestration and/or stenting to first alleviate organ ischemia. Once the patients had a resolution of organ failure, corrective open aortic repair will be performed.

• Study Type: Interventional
• Enrollment (Estimated): 236
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China, 361008
      • Xiamen Cardiovascular Hospital at Xiamen University
      • Contact: Xijie Wu; Phone Number: +86-13365910050; Email: wxjusa@163.com
      • Contact: Shuangkun Chen; Phone Number: +86-15695904322; Email: shuangkun_chen@foxmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Provision of informed consent prior to any study specific procedures;
• Acute type A aortic dissection is confirmed by computed tomography angiography;
• The symptoms onset within 2 weeks;

• Patients are diagnosed with ATAAD, with a new diagnosis of malperfusion syndrome ,by meeting both of the following criteria:

  1. Radiographic findings reveal occlusion of the corresponding arteries (including either coronary artery, either carotid artery, celiac trunk, superior mesenteric artery or either iliac artery);
  2. Clinical features of end organ ischemia (altered consciousness, paralysis, melena, abdominal pain, tenderness to palpation, loss of sensory or motor function of the lower extremities) OR laboratory findings suggestive of end organ ischemia (elevated cardiac enzymes, lactate, myoglobin, or creatine kinase).

Exclusion Criteria:

• Age <18 yr and >80 yr;
• Unstable condition with cardiac tamponade or aortic rupture on admission;
• Multiple types of malperfusion syndrome on admission;
• Bloody stools or melena on admission;
• Bilaterally fixed dilated pupils, hemorrhagic infarction or herniation of brain on admission;
• Cardiopulmonary arrest and required continuous uninterrupted cardiopulmonary resuscitation on admission;
• Irreversible multiple organ failure on admission;
• Life expectancy < 1 year;
• Patients and (or) their families refused surgery;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Optimized treatment strategies (OTS group); Patients randomized to OTS group will be treated with optimized treatment strategies.	Procedure: Optimized treatment strategies; The optimized strategies based on 6-hour threshold from symptom onset. For malperfused patients with symptom onset within 6 hours, central repair will be performed immediately. Additional stenting will be used in patients with persistent malperfusion. For malperfused patients with symptom onset beyond 6 hours, individualized delayed central repair according to the different types of MPS will be performed after organ function improved and the patient could tolerate central repair.
Active Comparator: Traditional treatment strategies (TTS group); Patients randomized to TTS group will be treated with traditional treatment strategies.	Procedure: Traditional treatment strategies; Immediate central repair will be performed for patients with coronary and cerebral malperfusion syndrome. However, for patients with mesenteric and lower extremity malperfusion syndrome, interventional therapy will be administered through fenestration and/or stenting to first alleviate organ ischemia. Once the patients had a resolution of organ failure, corrective open aortic repair will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative Mortality (OM)	Patients who died within 30 days	30-day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of composite of Major Adverse Pulmonary Events (MAPE)	Number of participants with MAPE which will include the composite rate of intubation >48 hours, pneumonia, reintubation, tracheostomy according to the Common Terminology Criteria for Adverse Events v4.0 (CTCAE)	30-day
Rate of composite of Major Adverse Events (MAE)	Number of participants with MAE which will include the composite rate of low cardiac output syndrome, new cerebrovascular accident, intestinal ischemia, lower limb necrosis, multiple organ failure according to Common Terminology Criteria for Adverse Events v4.0 (CTCAE)	30-day
Rate of reintervention	The number of participants who will require reoperation for distal aorta	3 year
Mid-term survival	The secondary endpoint of the study is the evaluation of mid-term survival	3 year

Collaborators and Investigators

• Sponsor: Xiamen Cardiovascular Hospital, Xiamen University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: July 26, 2024
• First Submitted That Met QC Criteria: July 31, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2024
• Last Update Submitted That Met QC Criteria: July 31, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Aortic dissection; Malperfusion syndrome; Optimized strategies; Central repair; Endovascular reperfusion
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome; Aortic Dissection
• Other Study ID Numbers: (2024) YLK-26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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