Acute Myocardial InfarctionNCT04359589
DSS's Role in Evaluating the Diagnosis and Treatment System of Ischemic Cardiovascular and Cerebrovascular Diseases
An observational study of Acute Myocardial Infarction and Acute Ischemic Stroke, run by First Affiliated Hospital Xi'an Jiaotong University at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Myocardial Infarction, Acute Ischemic Stroke, Ischemic Cardiovascular Disease
- How many people
- 1,900 participants
- Where
- 2 sitesChina
- Study dates
- 22 Jul 2020to 31 Dec 2021
- Phase
- Observational
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Show all 14Show fewer
- 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.
Who cannot join
- • 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 710000
Wanying Yang, MD, 0086-18392885451, 18392885451@163.com
- Recruiting
First Affiliated Hospital Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Xiaopu Zheng, MD, 0086-029-85323818, gaokenkx@163.com
About this study
Official title: The Research on DSS in Evaluating the Diagnosis and Treatment System of Acute Ischemic Cardiovascular and Cerebrovascular Diseases
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.
Read more
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.
Read the detailed description
The experiments as follows:
Experiment 1. Observe the dynamic changes of DSS level in acute ischemic cardiovascular and cerebrovascular diseases of different severity.
- Research object Acute myocardial infarction (AMI) group: 500 patients with AMI; Acute ischemic stroke group: 300 patients with acute ischemic stroke; Acute lower limb ischemia group: 300 subjects with acute lower limb ischemia; Control group: 200 healthy volunteers were included as controls. All the subjects were from the first and second affiliated hospitals of the Xi'an Jiaotong University and the Shaanxi Provincial People's Hospital;
- Collecting indicators 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. The investigators collected several demographics, clinical and analytical parameters. Age, gender, height and weight were recorded, and body mass index (kg/m2) was calculated. Blood pressure (BP) was measured three times or more by a nurse while patients were seated after 5 min of rest. Several parameters, including myocardial enzyme, serum uric acid, total cholesterol, total triglycerides low density lipoprotein-cholesterol, high density lipoprotein-cholesterol, estimated glomerular filtration rate and high sensitivity C-reactive protein were measured. The patient was included in all the clinical data after admission and as the admission diagnosis, including: medical history (including risk factors), physical examination, laboratory examination, imaging examination, nursing report, records of interventional operation and all the indicators of in-hospital examination.
- Analyze the regularity curve of DSS level in disease DSS levels of blood and urine were detected by gas chromatography -mass spectrometry (GC-MS). In the disease progression of patients with AMI, acute ischemic stroke and acute lower limb ischemia, the difference of DSS production was analyzed, and the regular curve of the dynamic change process of ischemic cardiovascular and cerebrovascular diseases was plotted based on the normal control group.
Experiment 2. To establish an assessment system of "circulatory integration" for acute ischemic cardiovascular and cerebrovascular diseases with DSS as the core.
- The Clinical outcomes on follow up 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 time of recurrence, complication or death, type of complication and cause of death were recorded in detail.
- Establish a diagnosis and treatment evaluation system Blood and urine DSS levels were measured by GC-MS. COX regression model analysis, including DSS level, basic information, risk factors, symptoms, physical examination, laboratory tests, image examination and electrocardiogram, assess the influence of various factors on major adverse events in patients with acute ischemic cardiovascular and cerebrovascular diseases and the prognosis of three diseases. Moreover, these indicators were used to build a scoring system, and analyze its correlation with prognosis.
Experiment 3. To verify the "circulatory integration" diagnosis and treatment evaluation system of acute ischemic cardiovascular and cerebrovascular diseases with DSS as the core
- Research Object AMI group: 200 patients with AMI; Acute ischemic stroke group: 200 patients with acute ischemic stroke; Acute lower limb ischemia group: 200 subjects with acute lower limb ischemia; All these subjects were from the first and second affiliated hospitals of the Xi'an Jiaotong University and the Shaanxi Provincial People's Hospital;
- Collecting Indicators Peripheral blood and morning urine were collected and measured.
- Follow up and record the outcome The major adverse events were observed and recorded in the same way as in the above-mentioned experiment.
- Verify the diagnosis and treatment evaluation system The newly established "circulatory integration" diagnosis and treatment evaluation system of acute ischemic cardiovascular and cerebrovascular diseases with DSS as the core was used to predict the prognosis of the newly included 600 patients with acute ischemic cardiovascular and cerebrovascular diseases. This paper analyzes the specificity and sensitivity of the newly built "circular integration" diagnosis and treatment evaluation system through its disease evaluation and actual adverse events.
- Keywords
- Acute myocardial infarction, Dan shen su, Acute lower limb ischemia
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of disease recurrence
Incidence of disease recurrence，including acute myocardial infarction, ischemic stroke and acute lower limb ischemia.
Measured: 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.
Measured: 12 months after admission
Incidence of all-cause death
All deaths were taken into account unless there is a definite cause of accidental death.
Measured: 12 months after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start22 Jul 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,900 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital of Xi'an Jiaotong University, Shaanxi Provincial People's Hospital
- Responsible party
- Sponsor
- Investigators
- Xiaopu Zheng, MD, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359589
- Sponsor's protocol ID
- 2019ZDLSF01-01-01
- Status last verified
- Aug 2021
- First submitted
- 21 Apr 2020
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Research on DSS in Evaluating the Diagnosis and Treatment System of Acute Ischemic Cardiovascular and Cerebrovascular Diseases
- ClinicalTrials.gov ID
- NCT04359589
- Acronym / sponsor ID
- 2019ZDLSF01-01-01
- Keywords
- Acute myocardial infarction, Dan shen su, Acute lower limb ischemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,900 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital of Xi'an Jiaotong University, Shaanxi Provincial People's Hospital
- Study start
- 22 Jul 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 24 Apr 2020 (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.
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.
Detailed description
The experiments as follows:
Experiment 1. Observe the dynamic changes of DSS level in acute ischemic cardiovascular and cerebrovascular diseases of different severity.
- Research object Acute myocardial infarction (AMI) group: 500 patients with AMI; Acute ischemic stroke group: 300 patients with acute ischemic stroke; Acute lower limb ischemia group: 300 subjects with acute lower limb ischemia; Control group: 200 healthy volunteers were included as controls. All the subjects were from the first and second affiliated hospitals of the Xi'an Jiaotong University and the Shaanxi Provincial People's Hospital;
- Collecting indicators 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. The investigators collected several demographics, clinical and analytical parameters. Age, gender, height and weight were recorded, and body mass index (kg/m2) was calculated. Blood pressure (BP) was measured three times or more by a nurse while patients were seated after 5 min of rest. Several parameters, including myocardial enzyme, serum uric acid, total cholesterol, total triglycerides low density lipoprotein-cholesterol, high density lipoprotein-cholesterol, estimated glomerular filtration rate and high sensitivity C-reactive protein were measured. The patient was included in all the clinical data after admission and as the admission diagnosis, including: medical history (including risk factors), physical examination, laboratory examination, imaging examination, nursing report, records of interventional operation and all the indicators of in-hospital examination.
- Analyze the regularity curve of DSS level in disease DSS levels of blood and urine were detected by gas chromatography -mass spectrometry (GC-MS). In the disease progression of patients with AMI, acute ischemic stroke and acute lower limb ischemia, the difference of DSS production was analyzed, and the regular curve of the dynamic change process of ischemic cardiovascular and cerebrovascular diseases was plotted based on the normal control group.
Experiment 2. To establish an assessment system of "circulatory integration" for acute ischemic cardiovascular and cerebrovascular diseases with DSS as the core.
- The Clinical outcomes on follow up 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 time of recurrence, complication or death, type of complication and cause of death were recorded in detail.
- Establish a diagnosis and treatment evaluation system Blood and urine DSS levels were measured by GC-MS. COX regression model analysis, including DSS level, basic information, risk factors, symptoms, physical examination, laboratory tests, image examination and electrocardiogram, assess the influence of various factors on major adverse events in patients with acute ischemic cardiovascular and cerebrovascular diseases and the prognosis of three diseases. Moreover, these indicators were used to build a scoring system, and analyze its correlation with prognosis.
Experiment 3. To verify the "circulatory integration" diagnosis and treatment evaluation system of acute ischemic cardiovascular and cerebrovascular diseases with DSS as the core
- Research Object AMI group: 200 patients with AMI; Acute ischemic stroke group: 200 patients with acute ischemic stroke; Acute lower limb ischemia group: 200 subjects with acute lower limb ischemia; All these subjects were from the first and second affiliated hospitals of the Xi'an Jiaotong University and the Shaanxi Provincial People's Hospital;
- Collecting Indicators Peripheral blood and morning urine were collected and measured.
- Follow up and record the outcome The major adverse events were observed and recorded in the same way as in the above-mentioned experiment.
- Verify the diagnosis and treatment evaluation system The newly established "circulatory integration" diagnosis and treatment evaluation system of acute ischemic cardiovascular and cerebrovascular diseases with DSS as the core was used to predict the prognosis of the newly included 600 patients with acute ischemic cardiovascular and cerebrovascular diseases. This paper analyzes the specificity and sensitivity of the newly built "circular integration" diagnosis and treatment evaluation system through its disease evaluation and actual adverse events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (14 listed)
- AMI patients:
- Acute ischemic stroke patients:
- Acute lower limb ischemia patients:
Key exclusion criteria (4 listed)
- • Patients with history of cardiogenic shock or cardiopulmonary resuscitation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of disease recurrence
Time frame: 12 months after admission
Incidence of disease recurrence，including acute myocardial infarction, ischemic stroke and acute lower limb ischemia.
Incidence of cardiac death
Time frame: 12 months after admission
All deaths were considered to have been from cardiac causes unless a explicit noncardiac cause could be documented.
Incidence of all-cause death
Time frame: 12 months after admission
All deaths were taken into account unless there is a definite cause of accidental death.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
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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.
Xiaopu Zheng, MD principal investigator
First Affiliated Hospital Xi'an Jiaotong University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction and Acute Ischemic Stroke, run by First Affiliated Hospital Xi'an Jiaotong University at 2 sites 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 14 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 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Xiaopu Zheng, MD (0086-029-85323818, gaokenkx@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of disease recurrence (time frame: 12 months after admission). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2021.