Aortic DissectionNCT05517356
Prospective Study of Tailored Management Strategies for Malperfusion Syndrome
A study testing Tailored management strategies in people with Aortic Dissection, run by Xiamen Cardiovascular Hospital, Xiamen University at 1 site in China.
Trial 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. 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?
- Tailored management strategies
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2024
- 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
- 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).
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Cardiac Surgery, Xiamen Cardiovascular Hospital of Xiamen University, School of Medicine, Xiamen University
Xiamen, Fujian, 361008
Shuangkun Chen, MD, +86-15695904322, 757450275@qq.com
About this study
Official title: PRospective Study of tailOred Management Strategies fOr Acute Type A Aortic Dissection complicatEd With Malperfusion Syndrome (PROMOTE)
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.
Read the detailed description
ATAAD complicated with malperfusion syndrome Malperfusion syndrome is the most devastating complication of acute type A aortic dissection (ATAAD), which has a poor clinical outcome and has operative mortality ranging from 29% to 89%. However, different views on management of malperfusion exist, with debating on addressing the dissection or the organ malperfusion in priority.
Current different treatment strategies for ATAAD with malperfusion syndrome Immediate central repair, restoration of true lumen flow and depressurization of the false lumen, is the most widely practiced approaches for treating ATAAD regardless of malperfusion syndrome. Nevertheless, with very high operative mortality by the conventional approach for patients with malperfusion, several studies have suggested that patients undergo endovascular reperfusion first until the malperfusion resolves, followed by delayed central repair. This strategy has produced better outcomes for patients, however, it also carries risks of interim mortality due to aortic rupture or multiple-organ failure before central repair. Moreover, a recent study suggested an alternative strategy, which performed aortic surgery and endovascular reperfusion in a hybrid approach for static malperfusion or dynamic malperfusion symptoms more than 6 hours symptoms onset. This alternative strategy improved outcomes with a mortality rate of 16.7%, which was still a little bit high. Overall, the outcomes of ATAAD patients with malperfusion syndrome still need to be improved.
Tailored management strategies The tailored management strategies were: 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.
Study Rationale As noted above, malperfusion syndrome is a rapidly lethal condition that every cardiovascular surgeon is faced with at some point. Despite the optimization of approaches for ATAAD presented with malperfusion in recent years, there appears to be some room to improve our outcomes even further. The investigators believe that the tailored management strategies, which aimed at reducing the duration of end-organ ischemia, may provide a promising treatment option for these patients. However, further prospective study and follow-up data are necessary to confirm the efficacy and safety of this new strategy.
- Conditions
- Aortic Dissection
- Being tested
- Tailored management strategies
- Keywords
- Tailored management strategies; Aortic dissection; Malperfusion syndrome; Central repair; Endovascular reperfusion.
- Medical subject headings
- Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored management strategiesProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: Tailored management strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality (number of all cause death)
All cause death
Measured: 12 months
Secondary outcomes (6)
Low cardiac output syndrome
Number of participants complicated with low cardiac output syndrome after surgery
Measured: 30 days
New cerebrovascular events
Number of participants complicated with new cerebrovascular events after surgery
Measured: 30 days
Intestinal necrosis
Number of participants complicated with intestinal necrosis after surgery
Measured: 30 days
Lower limb necrosis
Number of participants complicated with lower limb necrosis after surgery
Measured: 30 days
Multiple organ failure
Number of participants complicated with multiple organ failure after surgery
Measured: 30 days
Extracorporeal membrane oxygenation
Number of participants requiring extracorporeal membrane oxygenation after surgery
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start1 Jan 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Aortic DissectionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiamen Cardiovascular Hospital, Xiamen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xijie Wu, Xiamen Cardiovascular Hospital, Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517356
- Sponsor's protocol ID
- 2022YLK19
- Status last verified
- Aug 2022
- First submitted
- 16 Aug 2022
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 9436553Geirsson 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.
PubMed 17500002Girdauskas 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.
PubMed 19733865Ahmed 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.
PubMed 34977693Fann 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.
PubMed 2256762Ehrlich 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.
PubMed 11082396Girardi 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.
PubMed 15063257Uchida 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.
PubMed 29548594Yang 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.
PubMed 30474418Chiu 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.
PubMed 29615333Tsagakis 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.
PubMed 30529161
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRospective Study of tailOred Management Strategies fOr Acute Type A Aortic Dissection complicatEd With Malperfusion Syndrome (PROMOTE)
- ClinicalTrials.gov ID
- NCT05517356
- Acronym / sponsor ID
- 2022YLK19
- Conditions
- Aortic Dissection
- Keywords
- Tailored management strategies; Aortic dissection; Malperfusion syndrome; Central repair; Endovascular reperfusion.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Xiamen Cardiovascular Hospital, Xiamen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Aug 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.
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.
Detailed description
ATAAD complicated with malperfusion syndrome Malperfusion syndrome is the most devastating complication of acute type A aortic dissection (ATAAD), which has a poor clinical outcome and has operative mortality ranging from 29% to 89%. However, different views on management of malperfusion exist, with debating on addressing the dissection or the organ malperfusion in priority.
Current different treatment strategies for ATAAD with malperfusion syndrome Immediate central repair, restoration of true lumen flow and depressurization of the false lumen, is the most widely practiced approaches for treating ATAAD regardless of malperfusion syndrome. Nevertheless, with very high operative mortality by the conventional approach for patients with malperfusion, several studies have suggested that patients undergo endovascular reperfusion first until the malperfusion resolves, followed by delayed central repair. This strategy has produced better outcomes for patients, however, it also carries risks of interim mortality due to aortic rupture or multiple-organ failure before central repair. Moreover, a recent study suggested an alternative strategy, which performed aortic surgery and endovascular reperfusion in a hybrid approach for static malperfusion or dynamic malperfusion symptoms more than 6 hours symptoms onset. This alternative strategy improved outcomes with a mortality rate of 16.7%, which was still a little bit high. Overall, the outcomes of ATAAD patients with malperfusion syndrome still need to be improved.
Tailored management strategies The tailored management strategies were: 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.
Study Rationale As noted above, malperfusion syndrome is a rapidly lethal condition that every cardiovascular surgeon is faced with at some point. Despite the optimization of approaches for ATAAD presented with malperfusion in recent years, there appears to be some room to improve our outcomes even further. The investigators believe that the tailored management strategies, which aimed at reducing the duration of end-organ ischemia, may provide a promising treatment option for these patients. However, further prospective study and follow-up data are necessary to confirm the efficacy and safety of this new strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Malperfusion Cohort | Experimental | Procedure: Tailored management strategiesPatients 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (4 listed)
- 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;
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 |
|---|---|---|
| Tailored management strategiesOur 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. | Procedure or surgery | Malperfusion Cohort |
Primary outcome
Mortality (number of all cause death)
Time frame: 12 months
All cause death
6 secondary outcomes
Low cardiac output syndrome
Time frame: 30 days
New cerebrovascular events
Time frame: 30 days
Intestinal necrosis
Time frame: 30 days
Lower limb necrosis
Time frame: 30 days
Multiple organ failure
Time frame: 30 days
Extracorporeal membrane oxygenation
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Background: PubMed 9436553Deeb 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.
- Background: PubMed 17500002Geirsson 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.
- Background: PubMed 19733865Girdauskas 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.
- Background: PubMed 34977693Ahmed 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.
- Background: PubMed 2256762Fann 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.
- Background: PubMed 11082396Ehrlich 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.
- Background: PubMed 15063257Girardi 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.
- Background: PubMed 29548594Uchida 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.
- Background: PubMed 30474418Yang 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.
- Background: PubMed 29615333Chiu 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.
- Background: PubMed 30529161Tsagakis 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.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored management strategies in people with Aortic Dissection, run by Xiamen Cardiovascular Hospital, Xiamen 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 5 inclusion and 4 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 26 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xijie Wu, PhD (+86-13799959630, wxjusa@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (number of all cause death) (time frame: 12 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 NCT05517356, which also lists 11 linked publications.
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 26 Aug 2022.