DSS's Role in Evaluating the Diagnosis and Treatment System of Ischemic Cardiovascular and Cerebrovascular Diseases
The Research on DSS in Evaluating the Diagnosis and Treatment System of Acute Ischemic Cardiovascular and Cerebrovascular Diseases
1 other identifier
observational
1,900
1 country
2
Brief Summary
Background: Acute ischemic cardiovascular and cerebrovascular diseases are a kind of diseases with high incidence, rapid progression, poor prognosis and high mortality and disability rate of the circulatory system, mainly including acute myocardial infarction, acute ischemic stroke and acute limb ischemia, which place a heavy burden on individuals, families and society due to their severe prognosis and high medical costs. At present, the diagnosis and treatment of ischemic cardiovascular and cerebrovascular diseases mainly focus on single organ diagnosis and treatment of target organs, lacking of indicators to comprehensively evaluate the body's pathophysiology. As ischemic disease of the circulatory system, ischemic cardiovascular and cerebrovascular diseases have common pathophysiological basis such as ischemia, hypoxia and inflammation. These common pathophysiological basis suggests that different acute ischemic cardiovascular and cerebrovascular diseases can be monitored and evaluated from an integrated perspective, it suggests the possibility of comprehensive diagnosis, evaluation and treatment guidance. At present, the "circulatory integration" therapy represented by the combined treatment of heart and brain has achieved certain results, but there is no corresponding evaluation system to provide accurate guidance. Therefore, with the concept of "circulation integration", it is an urgent problem to find the common indicators of the circulation system and construct the hierarchical diagnosis and subsequent evaluation system of acute cardiovascular and cerebrovascular integration. The development of efficient and comprehensive stratified diagnosis and prognosis evaluation system is of great significance in clinical, market and social aspects. At the early stage of the efforts our team, it was found that Dan Shen Su-(±)-3, 4-dihydroxyphenylacetic acid (DSS) could be detected in the plasma and urine of patients with acute myocardial infarction and ischemic stroke through metabolomics. It has been proved that it can be generated by the transformation of dihydroxyphenylalanine by proteus mirabilis, and its structure is consistent with the water-soluble component of salvia miltiorrhiza, which is related to the body's states of ischemia, hypoxia and inflammation. The findings provide a material basis for the "circulatory integration" assessment of acute ischemic cardiovascular and cerebrovascular diseases. Objectives: This study aims at acute ischemic cardiovascular and cerebrovascular diseases, with the concept of "circulatory integration", to build a hierarchical diagnosis and prognosis evaluation system with DSS as the core, in order to improve the diagnosis rate and cure rate, improve the prognosis and reduce mortality of ischemic cardiovascular diseases. Methods: The project included 500 patients with acute myocardial infarction, 300 patients with acute ischemic stroke, 300 patients with acute lower limb ischemia, and 200 healthy controls in the Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, Peoples R China. Plasma and urine were collected during the disease process. Various relevant clinical indicators including DSS level were included, COX model was applied to analyze the influence of multiple factors on the prognosis of the above diseases, and the indicators were screened and the integrated stratified diagnosis and prognosis evaluation system of acute ischemic cardio-cerebrovascular system with DSS as the core were established. The newly established integrated stratified diagnosis and prognosis assessment system was used to evaluate 200 patients with each of the three diseases, and the sensitivity and specificity of the new assessment system were tested. And a simple, rapid and accurate method for detecting DSS was developed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2020
2 active sites
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
First Submitted
Initial submission to the registry
April 21, 2020
CompletedFirst Posted
Study publicly available on registry
April 24, 2020
CompletedStudy Start
First participant enrolled
July 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedAugust 26, 2021
August 1, 2021
1.4 years
April 21, 2020
August 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Incidence of disease recurrence
Incidence of disease recurrence，including acute myocardial infarction, ischemic stroke and acute lower limb ischemia.
12 months after admission
Incidence of cardiac death
All deaths were considered to have been from cardiac causes unless a explicit noncardiac cause could be documented.
12 months after admission
Incidence of all-cause death
All deaths were taken into account unless there is a definite cause of accidental death.
12 months after admission
Study Arms (4)
Acute myocardial infarction (AMI) group
700 patients with AMI;several demographics, clinical and analytical parameters were collected, and peripheral blood and morning urine were collected from the patients and the volunteers after admission on the first, second, third and seventh days for DSS detection.Observe the dynamic changes of DSS level in acute ischemic cardiovascular disease of different severity. Adverse events (survival outcome) were observed and recorded in the hospital and at 1, 3, 6, and 12 months after discharge. Major adverse events mainly include disease recurrence, cardiac death and all-cause death. The newly established "circulatory integration" diagnosis and treatment evaluation system of acute ischemic cardiovascular with DSS as the core was used to predict the prognosis of patients with acute ischemic cardiovascular diseases.
Acute ischemic stroke group
500 patients with acute ischemic; several demographics, clinical and analytical parameters were collected,and peripheral blood and morning urine were collected from the patients and the volunteers after admission on the first, second, third and seventh days for DSS detection.Observe the dynamic changes of DSS level in acute ischemic cerebrovascular disease of different severity.Adverse events (survival outcome) were observed and recorded in the hospital and at 1, 3, 6, and 12 months after discharge. Major adverse events mainly include disease recurrence, cardiac death and all-cause death. The newly established "circulatory integration" diagnosis and treatment evaluation system of acute ischemic cardiovascular with DSS as the core was used to predict the prognosis of patients with acute cerebrovascular diseases.
Acute lower limb ischemia group
500 patients with acute lower limb ischemia; several demographics, clinical and analytical parameters were collected,and peripheral blood and morning urine were collected from the patients and the volunteers after admission on the first, second, third and seventh days for DSS detection.Observe the dynamic changes of DSS level in lower limb ischemia disease of different severity.Adverse events (survival outcome) were observed and recorded in the hospital and at 1, 3, 6, and 12 months after discharge. Major adverse events mainly include disease recurrence, cardiac death and all-cause death. The newly established "circulatory integration" diagnosis and treatment evaluation system of lower limb ischemia disease with DSS as the core was used to predict the prognosis of patients with acute cerebrovascular diseases.
Control group
200 healthy volunteers were included as controls
Eligibility Criteria
The project included patients with acute myocardial infarction, patients with acute ischemic stroke, patients with acute lower limb ischemia and 200 healthy controls in the Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, Peoples R China. The study was approved by both Research and Ethics Committees of the First Affiliated Hospital of Xi'an JiaoTong University.
You may qualify if:
- AMI patients:
- Patients with age between 18 to 75.
- Patients with acute ST-segment elevation myocardial infarction less than 12 hours.
- Without taking DSS and dihydroxyphenylalanine-containing drugs at least one week before admission.
- Acute ischemic stroke patients:
- Patients with age between 18 to 75.
- Patients with acute ischemic stroke less than 12 hours.
- National institutes of health stroke scale (NIHSS) scores ranged from 4 to 20.
- Without taking DSS and dihydroxyphenylalanine-containing drugs at least one week before admission.
- Acute lower limb ischemia patients:
- Patients with age between 18 to 75.
- Patients with typical " 6P " symptom within 14 days: pain, pulselessness, pallor, paresthesia, paralysis and poikilothermia.
- The magnetic resonance imaging and ultrasonography of the lower extremity artery showed that there was ischemia in the lower extremity.
- Without taking DSS and dihydroxyphenylalanine-containing drugs at least one week before admission.
You may not qualify if:
- Patients with history of cardiogenic shock or cardiopulmonary resuscitation.
- Woman during pregnancy or lactation or anyone with mental disorder.
- A self-identified history of stroke, renal failure, severe arrhythmia or malignant tumor.
- Previous coronary artery bypass graft surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 710000, China
First Affiliated Hospital Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaopu Zheng, MD
First Affiliated Hospital Xi'an Jiaotong University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2020
First Posted
April 24, 2020
Study Start
July 22, 2020
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
August 26, 2021
Record last verified: 2021-08