NCT05517356

Brief Summary

Management strategy of malperfusion syndrome in acute type A aortic dissection (ATAAD) patients remains controversial, with different views on when the surgery should be offered. At present, the mortality of ATAAD patients complicated with malperfusion is stubbornly high. The purpose of this study is to improve the outcomes of ATAAD with malperfusion syndrome. The investigators formulated tailored management strategies for malperfused patients based on the duration of symptoms onset.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 26, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

August 26, 2022

Status Verified

August 1, 2022

Enrollment Period

3 years

First QC Date

August 16, 2022

Last Update Submit

August 25, 2022

Conditions

Aortic Dissection

Keywords

Tailored management strategies; Aortic dissection; Malperfusion syndrome; Central repair; Endovascular reperfusion.

Outcome Measures

Primary Outcomes (1)

  • Mortality (number of all cause death)

    All cause death

    12 months

Secondary Outcomes (6)

  • Low cardiac output syndrome

    30 days

  • New cerebrovascular events

    30 days

  • Intestinal necrosis

    30 days

  • Lower limb necrosis

    30 days

  • Multiple organ failure

    30 days

  • +1 more secondary outcomes

Study Arms (1)

Malperfusion Cohort

EXPERIMENTAL

Patients presenting to hospital with ATAAD meeting criteria for malperfusion syndrome which includes both components: 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 (abnormal left ventricular wall motion, disorder of consciousness or paralysis, abdominal pain, distended abdomen, pulselessness, loss of sensory or motor function of the lower extremities) OR Laboratory findings suggestive of end organ ischemia (elevated troponin, elevated creatine kinase, lactic acidosis, elevated myoglobin).

Procedure: Tailored management strategies

Interventions

Tailored management strategiesPROCEDURE

Our basic surgical strategies for the central repair operations for ATAAD are as follows. As arterial lines for cardiopulmonary bypass, side branches of the axillary and femoral arteries were used. Circulatory arrest was established when the nasopharyngeal temperature reached 25°C. Anterograde selective cerebral perfusion was performed through the right axillary artery, and the brain was perfused at approximately 5 mL/kg/min. The extent of aortic replacement was determined according to the extent of dissection involvement. For malperfused patients with symptom onset within 6 hours, the immediate central repair was performed followed by repeat CTA postoperatively, and endovascular reperfusion was applied if the malperfusion persisted. While for patients with symptom onset beyond 6 hours, delayed central repair were performed after the organ functions improved.

Malperfusion Cohort

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute type A aortic dissection is confirmed by CTA;
  • The symptoms onset time \< 2 weeks;
  • Patients diagnosed with an ATAAD , with a new diagnosis of malperfusion syndrome, by meeting both of the following criteria:
  • Radiographic findings reveal occlusion of the corresponding arteries (including either coronary artery, either carotid artery, celiac trunk, superior mesenteric artery or either iliac artery)
  • Clinical features of end organ ischemia (abnormal left ventricular wall motion, disorder of consciousness or paralysis, abdominal pain, distended abdomen, pulselessness, loss of sensory or motor function of the lower extremities) OR Laboratory findings suggestive of end organ ischemia (elevated troponin, elevated creatine kinase, lactic acidosis, elevated myoglobin).

You may not qualify if:

  • The branch arteries did not involved by ATAAD (non-malperfusion);
  • Patients presented with bloody stools or melena on admission;
  • Patients presented with bilaterally fixed dilated pupils, hemorrhagic infarction or herniation of brain;
  • Patients and (or) their families refused surgery;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiac Surgery, Xiamen Cardiovascular Hospital of Xiamen University, School of Medicine, Xiamen University

Xiamen, Fujian, 361008, China

RECRUITING

Related Publications (11)

  • Deeb GM, Williams DM, Bolling SF, Quint LE, Monaghan H, Sievers J, Karavite D, Shea M. Surgical delay for acute type A dissection with malperfusion. Ann Thorac Surg. 1997 Dec;64(6):1669-75; discussion 1675-7. doi: 10.1016/s0003-4975(97)01100-4.

    PMID: 9436553BACKGROUND

  • Geirsson A, Szeto WY, Pochettino A, McGarvey ML, Keane MG, Woo YJ, Augoustides JG, Bavaria JE. Significance of malperfusion syndromes prior to contemporary surgical repair for acute type A dissection: outcomes and need for additional revascularizations. Eur J Cardiothorac Surg. 2007 Aug;32(2):255-62. doi: 10.1016/j.ejcts.2007.04.012. Epub 2007 May 17.

    PMID: 17500002BACKGROUND

  • Girdauskas E, Kuntze T, Borger MA, Falk V, Mohr FW. Surgical risk of preoperative malperfusion in acute type A aortic dissection. J Thorac Cardiovasc Surg. 2009 Dec;138(6):1363-9. doi: 10.1016/j.jtcvs.2009.04.059. Epub 2009 Sep 5.

    PMID: 19733865BACKGROUND

  • Ahmed Y, van Bakel PAJ, Patel HJ. Addressing malperfusion first before repairing type A dissection. JTCVS Tech. 2021 May 4;10:1-5. doi: 10.1016/j.xjtc.2021.04.029. eCollection 2021 Dec. No abstract available.

    PMID: 34977693BACKGROUND

  • Fann JI, Sarris GE, Mitchell RS, Shumway NE, Stinson EB, Oyer PE, Miller DC. Treatment of patients with aortic dissection presenting with peripheral vascular complications. Ann Surg. 1990 Dec;212(6):705-13. doi: 10.1097/00000658-199012000-00009.

    PMID: 2256762BACKGROUND

  • Ehrlich MP, Ergin MA, McCullough JN, Lansman SL, Galla JD, Bodian CA, Apaydin A, Griepp RB. Results of immediate surgical treatment of all acute type A dissections. Circulation. 2000 Nov 7;102(19 Suppl 3):III248-52. doi: 10.1161/01.cir.102.suppl_3.iii-248.

    PMID: 11082396BACKGROUND

  • Girardi LN, Krieger KH, Lee LY, Mack CA, Tortolani AJ, Isom OW. Management strategies for type A dissection complicated by peripheral vascular malperfusion. Ann Thorac Surg. 2004 Apr;77(4):1309-14; discussion 1314. doi: 10.1016/j.athoracsur.2003.09.056.

    PMID: 15063257BACKGROUND

  • Uchida K, Karube N, Kasama K, Minami T, Yasuda S, Goda M, Suzuki S, Imoto K, Masuda M. Early reperfusion strategy improves the outcomes of surgery for type A acute aortic dissection with malperfusion. J Thorac Cardiovasc Surg. 2018 Aug;156(2):483-489. doi: 10.1016/j.jtcvs.2018.02.007. Epub 2018 Feb 13.

    PMID: 29548594BACKGROUND

  • Yang B, Rosati CM, Norton EL, Kim KM, Khaja MS, Dasika N, Wu X, Hornsby WE, Patel HJ, Deeb GM, Williams DM. Endovascular Fenestration/Stenting First Followed by Delayed Open Aortic Repair for Acute Type A Aortic Dissection With Malperfusion Syndrome. Circulation. 2018 Nov 6;138(19):2091-2103. doi: 10.1161/CIRCULATIONAHA.118.036328.

    PMID: 30474418BACKGROUND

  • Chiu P, Tsou S, Goldstone AB, Louie M, Woo YJ, Fischbein MP. Immediate operation for acute type A aortic dissection complicated by visceral or peripheral malperfusion. J Thorac Cardiovasc Surg. 2018 Jul;156(1):18-24.e3. doi: 10.1016/j.jtcvs.2018.01.096. Epub 2018 Feb 21.

    PMID: 29615333BACKGROUND

  • Tsagakis K, Janosi RA, Frey UH, Schlosser T, Chiesa R, Rassaf T, Jakob H. True Lumen Stabilization to Overcome Malperfusion in Acute Type I Aortic Dissection. Semin Thorac Cardiovasc Surg. 2019 Winter;31(4):740-748. doi: 10.1053/j.semtcvs.2018.11.012. Epub 2018 Dec 8.

    PMID: 30529161BACKGROUND

MeSH Terms

Conditions

Aortic Dissection

Condition Hierarchy (Ancestors)

Dissection, Blood VesselAneurysmVascular DiseasesCardiovascular DiseasesAcute Aortic SyndromeAortic Diseases

Central Study Contacts

Xijie Wu, PhD

CONTACT

+86-13799959630wxjusa@163.com

Shuangkun Chen, MD

CONTACT

+86-15695904322757450275@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of Cardiosurgery, Clinical Professor

Study Record Dates

First Submitted

August 16, 2022

First Posted

August 26, 2022

Study Start

January 1, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

August 26, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)