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出境医 / 临床实验 / Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (Multicenter Retrospective Study) III

Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (Multicenter Retrospective Study) III

Study Description
Brief Summary:
Anatomopathological classifications have been well identified in aortic dissection with important therapeutic implications. The authors evaluated the inflammatory response in patients with aortic dissection (AD) and assessed the presence of distinct inflammatory subphenotypes within this disease.

Condition or disease Intervention/treatment
Aortic Dissection Biological: inflammatory response

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Inflammatory Response and Anti-inflammatory Action for Aortopathy & Arteriopathy (5A-Plan): A Multicenter Retrospective Study
Actual Study Start Date : January 1, 2021
Actual Primary Completion Date : August 30, 2021
Actual Study Completion Date : August 30, 2021
Arms and Interventions
Group/Cohort Intervention/treatment
inflammatory subphenotype Biological: inflammatory response
laboratory data (leukocyte, neutrophils, monocyte, lymphocytes, platelet, fibrinogen, D-dimer, neutrophils-lymphocyte ratio, platelet-lymphocyte ratio, lymphocyte-monocyte ratio)
Outcome Measures
Primary Outcome Measures :
  1. 30-day mortality [ Time Frame: 30 days after surgery ]
    any cause death within 30 days of surgery


Secondary Outcome Measures :
  1. ICU mortality [ Time Frame: 7 days after surgery ]
    any cause death within ICU


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients underwent venipuncture during primary evaluation in the Emergency Department. Venous blood samples were immediately sent to the laboratory for analysis.
Criteria

Inclusion Criteria:

  • acute type Aortic dissection;

Exclusion Criteria:

  • Iatrogenic aortic dissection OR traumatic aortic dissection
  • Patients with hematological diseases, infectious diseases, malignant tumors, immune system diseases, or severe liver diseases.
  • Preoperative use of mechanical ventilation, blood transfusion, renal replacement therapy, extracorporeal membrane oxygenation, or intra-aortic balloon pump during the current admission.
Contacts and Locations

Locations
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China, Jiangsu
The first affiliated hospital of nanjing medical university
Nanjing, Jiangsu, China, 210029
Sponsors and Collaborators
Nanjing Medical University
The First Affiliated Hospital with Nanjing Medical University
Beijing Anzhen Hospital
The Affiliated Hospital of Qingdao University
The First Affiliated Hospital of Shantou University Medical College
The First Affiliated Hospital of Guangzhou Medical University
TEDA International Cardiovascular Hospital
Xiamen Cardiovascular Hospital
Shanghai East Hospital Tongji University
Tianjin Chest Hospital, Tianjin Medical University
Nanjing First Hospital, Nanjing Medical University
Xiangya Hospital of Central South University
First Affiliated Hospital Bengbu Medical College
Tracking Information
First Submitted Date June 3, 2021
First Posted Date June 8, 2021
Last Update Posted Date October 26, 2021
Actual Study Start Date January 1, 2021
Actual Primary Completion Date August 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 3, 2021) 		30-day mortality [ Time Frame: 30 days after surgery ]
any cause death within 30 days of surgery
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 3, 2021) 		ICU mortality [ Time Frame: 7 days after surgery ]
any cause death within ICU
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (Multicenter Retrospective Study) III
Official Title Inflammatory Response and Anti-inflammatory Action for Aortopathy & Arteriopathy (5A-Plan): A Multicenter Retrospective Study
Brief Summary Anatomopathological classifications have been well identified in aortic dissection with important therapeutic implications. The authors evaluated the inflammatory response in patients with aortic dissection (AD) and assessed the presence of distinct inflammatory subphenotypes within this disease.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients underwent venipuncture during primary evaluation in the Emergency Department. Venous blood samples were immediately sent to the laboratory for analysis.
Condition Aortic Dissection
Intervention Biological: inflammatory response
laboratory data (leukocyte, neutrophils, monocyte, lymphocytes, platelet, fibrinogen, D-dimer, neutrophils-lymphocyte ratio, platelet-lymphocyte ratio, lymphocyte-monocyte ratio)
Study Groups/Cohorts inflammatory subphenotype
Intervention: Biological: inflammatory response
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 7, 2021) 		2000
Original Estimated Enrollment
 (submitted: June 3, 2021) 		1000
Actual Study Completion Date August 30, 2021
Actual Primary Completion Date August 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • acute type Aortic dissection;

Exclusion Criteria:

  • Iatrogenic aortic dissection OR traumatic aortic dissection
  • Patients with hematological diseases, infectious diseases, malignant tumors, immune system diseases, or severe liver diseases.
  • Preoperative use of mechanical ventilation, blood transfusion, renal replacement therapy, extracorporeal membrane oxygenation, or intra-aortic balloon pump during the current admission.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04918108
Other Study ID Numbers 5A-Plan III
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Hong Liu, Nanjing Medical University
Study Sponsor Nanjing Medical University
Collaborators
  • The First Affiliated Hospital with Nanjing Medical University
  • Beijing Anzhen Hospital
  • The Affiliated Hospital of Qingdao University
  • The First Affiliated Hospital of Shantou University Medical College
  • The First Affiliated Hospital of Guangzhou Medical University
  • TEDA International Cardiovascular Hospital
  • Xiamen Cardiovascular Hospital
  • Shanghai East Hospital Tongji University
  • Tianjin Chest Hospital, Tianjin Medical University
  • Nanjing First Hospital, Nanjing Medical University
  • Xiangya Hospital of Central South University
  • First Affiliated Hospital Bengbu Medical College
Investigators Not Provided
PRS Account Nanjing Medical University
Verification Date October 2021