ST-elevation Myocardial InfarctionGOODINCT03074214
Prognostic Value of Copeptin for Infarct Size and Prognosis in Patients With ST-elevation Myocardial Infarction
An observational study of ST-elevation Myocardial Infarction, run by Shengjing Hospital at 1 site in China.
Trial summary
ST-elevation myocardial infarction (STEMI) has a serious health threaten to population. PCI, which can timely restore the blood flow to the ischemic myocardium, is a well-proved measure in STEMI management. However, the process of the restoration can induce injury. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ST-elevation Myocardial Infarction
- What is being tested?
- percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- How many people
- 275 participants
- Where
- 1 siteChina
- Study dates
- 6 Mar 2017to 31 Aug 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: 275 patients with STEMI receiving PPCI in department of Cardiology, Shengjing Hospital of China Medical University from March 1, 2017 to February 28, 2019
Who may be able to join
- chest pain present less than 12 hours from onset of pain to time of catheterization;
- significant ST-segment elevation (at least 0.1 mV in two or more standard leads or at least 0.2 mV in two or more contiguous precordial leads) or a new left bundle branch block;
- receiving primary PCI.
Who cannot join
- Patients with conditions other than STEMI that could cause increased copeptin levels, such as renal dysfunction (eGFR<30 ml/min), liver failure, respiratory tract infection, stroke, sepsis, hyponatremia (Serum sodium concentration<135mmol/L), central diabetes insipidus or malignancy;
- Patients with contraindications to perform cardiac magnetic resonance;
- Patients with cardiogenic shock (Killip class IV);
- Patients in whom reperfusion therapy failed;
- Patients who were referred for emergency coronary artery bypass grafting (CABG) in view of unfavourable coronary anatomy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 8611004
Hong Wang, Doctor, 8602496615 ext. 10026, llwyh@sj-hospital.org
Qiyong Guo, Doctor, 8602496615 ext. 10027, guoqy@sj-hospital.org
About this study
Official title: Study of Prognostic Value of Copeptin for Myocardial Infarct Size and 6-month Prognosis in Patients With ST-elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention: GOOD I Study
ST-elevation myocardial infarction (STEMI) has a serious health threaten to population. PCI, which can timely restore the blood flow to the ischemic myocardium, is a well-proved measure in STEMI management. However, the process of the restoration can induce injury. The phenomenon is defined as ischemia/reperfusion (I/R) injury. The studies indicate that I/R injury accounts for up to 50% of the final myocardial infarct size. However, previous attempts to target known mediators of myocardial I/R injury in patients have been disappointing, leading to calls for a reevaluation of factors affecting myocardial I/R injury [1]. Arginine vasopressin (AVP), that response to acute illness, is unstable and cleared rapidly from the circulation. However, copeptin, the C-terminal portion of provasopressin, is released in equimolar amounts to AVP and is easy to determine. So, copeptin can be a surrogate marker for AVP secretion. Recently, copeptin was found to serve as a potential prognostic biomarker in heart failure and acute myocardial infarction (AMI). AMI can activate the AVP axis, which have a causative role in the evolution of heart failure. Increasing copeptin was shown to correlate with myocardial remodeling, mortality and morbidity. In patients with STEMI, myocardial infarct size is a stronger outcome predictor than LV function, and is related to LV remodeling, which often indicates a significant worse prognosis after AMI. As the gold standard for characterisation of cardiac structure and function, cardiac magnetic resonance (CMR) parameters can serve as surrogate end points in clinical trials of STEMI. We hypothesised that plasma copeptin values, tested before and after PCI, are related to myocardial infarct size, myocardial function both and outcomes at baseline and 6 months follow-up as assessed by CMR in patients with STEMI.
Read the detailed description
Acute myocardial infarction (AMI) is a major concern in public health in China. Ischemia/reperfusion injury cripples the treatment effect of reperfusion management, and increases the final myocardial infarct size. Copeptin is related to the prognosis of heart failure and AMI, and may be a potential prognostic biomarker for myocardial infarct size, myocardial function and outcomes in patients with STEMI undergoing PCI.This study will enroll consecutive STEMI patients undergoing PCI, who meet the inclusion and exclusion criteria, in a large-scale hospital in Northeast China. After obtaining an informed consent, blood samples will be drawn at the time of before, immediately after, and 3 days after PPCI. They will be collected in EDTA tubes and centrifuged for 10 min at 2000 g within 0.5 h. Plasma will be stored at -80°C until analysis. Plasma copeptin concentrations will be determined by a commercially available automated immunofluorescent assay (R\&D Systems Inc. Minneapolis, USA). And other information about symptoms, functioning, quality of life, medical care, demographic characteristics, medical history, clinical features, diagnostic tests, medications and procedural data will be also collected. Baseline CMR will be performed 3-5 days after PPCI. All scans were performed on a 3.0 Tesla scanner. At 1 month, 3 month, and 12 month after discharge, participants will receive a follow-up by phone. At 6 month after discharge, participants will return to the clinic for follow up visits, and a face-to-face interview will be conducted to get information about clinical events, symptoms, functioning, quality of life, and medical care during the recovery period. Follow-up CMR scan will be conducted. Follow-up blood samples will be drawn for testing copeptin.
Sample Size Calculation A study size analysis was performed using PASS (version 11.0.4, 2011, NCSS, LLC, USA). In a previous study, the 90-day primary composite end point of all-causes death, ventricular fibrillation, cardiogenic shock, and congestive heart failure requiring rehospitalization or an emergency room visit through 90 days was 10.3% in STEMI patients undergoing PCI. [1] Although available data for detecting clinically relevance between copeptin and prognosis in STEMI patients undergoing PCI was limited, a previous study demonstrated that a high concentration (quartile 4 vs. quartiles 1 to 3) of copeptin identified an increased risk of CV death or HF (HR:2.80,95%CI:2.24-3.51,P<0.001). [2] When the ratio between groups1 and 2 is 3:1, an overall sample size of 275 subjects, of which 207 are in group 1 and 68 are in group 2, achieves 90% power at a 0.0500 significance level to detect a difference of 0.1280 between 0.9290 and 0.8010--the proportions surviving in groups 1 and 2, respectively. The proportion of patients lost during follow up was 0.1000.
- Conditions
- ST-elevation Myocardial Infarction
- Being tested
- percutaneous coronary intervention
- Keywords
- copeptin, myocardial infarct size, prognosis, ST-elevation myocardial infarction, percutaneous coronary intervention
- Medical subject headings
- ST Elevation Myocardial Infarction, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous coronary interventionProcedure or surgery
All STEMI patients enrolled will at first receive "Device"(such as: stent or balloon) treatment for their coronary artery.
| Study group | Role | What they receive |
|---|---|---|
| STEMI patients receiving PCI | patients with STEMI receiving percutaneous coronary intervention Receives: Procedure: percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events (MACE)
Composite of MACE including cardiac death, non-fatal myocardial reinfarction, unplanned repeat revascularization, congestive heart failure or angina requiring rehospitalization or an emergency room visit, ventricular fibrillation or ventricular tachycardia with hemodynamic instability
Measured: 6 months
Secondary outcomes (17)
All-cause death
All-cause death
Measured: 6 months
Cardiac death
Cardiac death
Measured: 6 months
unplanned repeat revascularization
unplanned repeat revascularization which included any unplanned repeat PCI or surgical bypass of target or non-target vessels
Measured: 6 months
congestive heart failure requiring rehospitalization or an emergency room visit
congestive heart failure requiring rehospitalization or an emergency room visit
Measured: 6 months
angina requiring rehospitalization or an emergency room visit
angina requiring rehospitalization or an emergency room visit
Measured: 6 months
ventricular fibrillation or severe ventricular tachycardia
ventricular fibrillation or severe ventricular tachycardia with hemodynamic instability occurring more than 2 hours after PCI
Measured: 6 months
acute heart failure during the index hospitalization
acute heart failure during the index hospitalization
Measured: 6 months
in-stent stent thrombosis
acute, subacute or chronic in-stent stent thrombosis
Measured: 6 months
contrast-induced nephropathy
Contrast-induced nephropathy was defined as an increase in serum creatinine concentration ≥0.5 mg/dl (44.2 mmol/l) or ≥25% above baseline 72 h after exposure to the contrast medium.
Measured: 6 months
ischemia stroke
ischemia stroke was defined as an acute event of non-hemorrhagic cerebrovascular origin causing focal or global neurologic dysfunction lasting >24 h, which was confirmed by both clinical and radiographic criteria.
Measured: 6 months
Bleeding Academic Research Consortium Definition for Bleeding: type 3 or 5
Bleeding Academic Research Consortium Definition for Bleeding: Type 3 Type 3a Overt bleeding plus hemoglobin drop of 3 to 5 g/dL* (provided hemoglobin drop is related to bleed) Any transfusion with overt bleeding Type 3b Overt bleeding plus hemoglobin drop 5 g/dL* (provided hemoglobin drop is related to bleed) Cardiac tamponade Bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid) Bleeding requiring intravenous vasoactive agents;Type 3c Intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal) Subcategories confirmed by autopsy or imaging or lumbar puncture Intraocular bleed compromising vision Type 5: fatal bleeding Type 5a Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious Type 5b Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation
Measured: 6 months
Seattle angina questionnaire (SAQ)
Seattle angina questionnaire (SAQ)
Measured: 6 months
Quality of life (EQ-5D)
Quality of life (EQ-5D)
Measured: 6 months
Depression (PHQ-8)
Depression (PHQ-8)
Measured: 6 months
Stress (Chinese 14-item PSS)
Stress (Chinese 14-item PSS)
Measured: 6 months
Cognitive function (MMSE)
Cognitive function (MMSE)
Measured: 6 months
myocardial infarct size
myocardial infarct size
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start6 Mar 2017
- Primary completion28 Feb 2019 (estimated)
- Study completion31 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ST-elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe 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
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YU Tong-tong, Shengjing Hospital
- Investigators
- Zhaoqing Su, Doctor, Study chair, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074214
- Sponsor's protocol ID
- 2016PS373K
- Acronym
- GOODI
- Status last verified
- Mar 2017
- First submitted
- 28 Feb 2017
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not share IPD to protect our data very well.
Publications
Ellis SG, Tendera M, de Belder MA, van Boven AJ, Widimsky P, Janssens L, Andersen HR, Betriu A, Savonitto S, Adamus J, Peruga JZ, Kosmider M, Katz O, Neunteufl T, Jorgova J, Dorobantu M, Grinfeld L, Armstrong P, Brodie BR, Herrmann HC, Montalescot G, Neumann FJ, Effron MB, Barnathan ES, Topol EJ; FINESSE Investigators. Facilitated PCI in patients with ST-elevation myocardial infarction. N Engl J Med. 2008 May 22;358(21):2205-17. doi: 10.1056/NEJMoa0706816.
PubMed 18499565O'Malley RG, Bonaca MP, Scirica BM, Murphy SA, Jarolim P, Sabatine MS, Braunwald E, Morrow DA. Prognostic performance of multiple biomarkers in patients with non-ST-segment elevation acute coronary syndrome: analysis from the MERLIN-TIMI 36 trial (Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST-Elevation Acute Coronary Syndromes-Thrombolysis In Myocardial Infarction 36). J Am Coll Cardiol. 2014 Apr 29;63(16):1644-53. doi: 10.1016/j.jacc.2013.12.034. Epub 2014 Feb 13.
PubMed 24530676
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Prognostic Value of Copeptin for Myocardial Infarct Size and 6-month Prognosis in Patients With ST-elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention: GOOD I Study
- ClinicalTrials.gov ID
- NCT03074214
- Acronym / sponsor ID
- GOODI / 2016PS373K
- Conditions
- ST-elevation Myocardial Infarction
- Keywords
- copeptin, myocardial infarct size, prognosis, ST-elevation myocardial infarction, percutaneous coronary intervention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 28 Feb 2019 (estimated)
- Study completion
- 31 Aug 2019 (estimated)
- First posted
- 8 Mar 2017 (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.
ST-elevation myocardial infarction (STEMI) has a serious health threaten to population. PCI, which can timely restore the blood flow to the ischemic myocardium, is a well-proved measure in STEMI management. However, the process of the restoration can induce injury. The phenomenon is defined as ischemia/reperfusion (I/R) injury. The studies indicate that I/R injury accounts for up to 50% of the final myocardial infarct size. However, previous attempts to target known mediators of myocardial I/R injury in patients have been disappointing, leading to calls for a reevaluation of factors affecting myocardial I/R injury [1]. Arginine vasopressin (AVP), that response to acute illness, is unstable and cleared rapidly from the circulation. However, copeptin, the C-terminal portion of provasopressin, is released in equimolar amounts to AVP and is easy to determine. So, copeptin can be a surrogate marker for AVP secretion. Recently, copeptin was found to serve as a potential prognostic biomarker in heart failure and acute myocardial infarction (AMI). AMI can activate the AVP axis, which have a causative role in the evolution of heart failure. Increasing copeptin was shown to correlate with myocardial remodeling, mortality and morbidity. In patients with STEMI, myocardial infarct size is a stronger outcome predictor than LV function, and is related to LV remodeling, which often indicates a significant worse prognosis after AMI. As the gold standard for characterisation of cardiac structure and function, cardiac magnetic resonance (CMR) parameters can serve as surrogate end points in clinical trials of STEMI. We hypothesised that plasma copeptin values, tested before and after PCI, are related to myocardial infarct size, myocardial function both and outcomes at baseline and 6 months follow-up as assessed by CMR in patients with STEMI.
Detailed description
Acute myocardial infarction (AMI) is a major concern in public health in China. Ischemia/reperfusion injury cripples the treatment effect of reperfusion management, and increases the final myocardial infarct size. Copeptin is related to the prognosis of heart failure and AMI, and may be a potential prognostic biomarker for myocardial infarct size, myocardial function and outcomes in patients with STEMI undergoing PCI.This study will enroll consecutive STEMI patients undergoing PCI, who meet the inclusion and exclusion criteria, in a large-scale hospital in Northeast China. After obtaining an informed consent, blood samples will be drawn at the time of before, immediately after, and 3 days after PPCI. They will be collected in EDTA tubes and centrifuged for 10 min at 2000 g within 0.5 h. Plasma will be stored at -80°C until analysis. Plasma copeptin concentrations will be determined by a commercially available automated immunofluorescent assay (R\&D Systems Inc. Minneapolis, USA). And other information about symptoms, functioning, quality of life, medical care, demographic characteristics, medical history, clinical features, diagnostic tests, medications and procedural data will be also collected. Baseline CMR will be performed 3-5 days after PPCI. All scans were performed on a 3.0 Tesla scanner. At 1 month, 3 month, and 12 month after discharge, participants will receive a follow-up by phone. At 6 month after discharge, participants will return to the clinic for follow up visits, and a face-to-face interview will be conducted to get information about clinical events, symptoms, functioning, quality of life, and medical care during the recovery period. Follow-up CMR scan will be conducted. Follow-up blood samples will be drawn for testing copeptin.
Sample Size Calculation A study size analysis was performed using PASS (version 11.0.4, 2011, NCSS, LLC, USA). In a previous study, the 90-day primary composite end point of all-causes death, ventricular fibrillation, cardiogenic shock, and congestive heart failure requiring rehospitalization or an emergency room visit through 90 days was 10.3% in STEMI patients undergoing PCI. [1] Although available data for detecting clinically relevance between copeptin and prognosis in STEMI patients undergoing PCI was limited, a previous study demonstrated that a high concentration (quartile 4 vs. quartiles 1 to 3) of copeptin identified an increased risk of CV death or HF (HR:2.80,95%CI:2.24-3.51,P<0.001). [2] When the ratio between groups1 and 2 is 3:1, an overall sample size of 275 subjects, of which 207 are in group 1 and 68 are in group 2, achieves 90% power at a 0.0500 significance level to detect a difference of 0.1280 between 0.9290 and 0.8010--the proportions surviving in groups 1 and 2, respectively. The proportion of patients lost during follow up was 0.1000.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STEMI patients receiving PCI | – | Procedure: percutaneous coronary interventionpatients with STEMI receiving percutaneous coronary intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 275 patients with STEMI receiving PPCI in department of Cardiology, Shengjing Hospital of China Medical University from March 1, 2017 to February 28, 2019
Key inclusion criteria (3 listed)
- chest pain present less than 12 hours from onset of pain to time of catheterization;
- significant ST-segment elevation (at least 0.1 mV in two or more standard leads or at least 0.2 mV in two or more contiguous precordial leads) or a new left bundle branch block;
- receiving primary PCI.
Key exclusion criteria (5 listed)
- Patients with conditions other than STEMI that could cause increased copeptin levels, such as renal dysfunction (eGFR<30 ml/min), liver failure, respiratory tract infection, stroke, sepsis, hyponatremia (Serum sodium concentration<135mmol/L), central diabetes insipidus or malignancy;
- Patients with contraindications to perform cardiac magnetic resonance;
- Patients with cardiogenic shock (Killip class IV);
- Patients in whom reperfusion therapy failed;
- Patients who were referred for emergency coronary artery bypass grafting (CABG) in view of unfavourable coronary anatomy.
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 |
|---|---|---|
| percutaneous coronary interventionAll STEMI patients enrolled will at first receive "Device"(such as: stent or balloon) treatment for their coronary artery. | Procedure or surgery | STEMI patients receiving PCI |
Primary outcome
Major adverse cardiovascular events (MACE)
Time frame: 6 months
Composite of MACE including cardiac death, non-fatal myocardial reinfarction, unplanned repeat revascularization, congestive heart failure or angina requiring rehospitalization or an emergency room visit, ventricular fibrillation or ventricular tachycardia with hemodynamic instability
17 secondary outcomes
All-cause death
Time frame: 6 months
Cardiac death
Time frame: 6 months
unplanned repeat revascularization
Time frame: 6 months
congestive heart failure requiring rehospitalization or an emergency room visit
Time frame: 6 months
angina requiring rehospitalization or an emergency room visit
Time frame: 6 months
ventricular fibrillation or severe ventricular tachycardia
Time frame: 6 months
acute heart failure during the index hospitalization
Time frame: 6 months
in-stent stent thrombosis
Time frame: 6 months
contrast-induced nephropathy
Time frame: 6 months
ischemia stroke
Time frame: 6 months
Bleeding Academic Research Consortium Definition for Bleeding: type 3 or 5
Time frame: 6 months
Seattle angina questionnaire (SAQ)
Time frame: 6 months
Quality of life (EQ-5D)
Time frame: 6 months
Depression (PHQ-8)
Time frame: 6 months
Stress (Chinese 14-item PSS)
Time frame: 6 months
Cognitive function (MMSE)
Time frame: 6 months
myocardial infarct size
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
- Background: PubMed 18499565Ellis SG, Tendera M, de Belder MA, van Boven AJ, Widimsky P, Janssens L, Andersen HR, Betriu A, Savonitto S, Adamus J, Peruga JZ, Kosmider M, Katz O, Neunteufl T, Jorgova J, Dorobantu M, Grinfeld L, Armstrong P, Brodie BR, Herrmann HC, Montalescot G, Neumann FJ, Effron MB, Barnathan ES, Topol EJ; FINESSE Investigators. Facilitated PCI in patients with ST-elevation myocardial infarction. N Engl J Med. 2008 May 22;358(21):2205-17. doi: 10.1056/NEJMoa0706816.
- Background: PubMed 24530676O'Malley RG, Bonaca MP, Scirica BM, Murphy SA, Jarolim P, Sabatine MS, Braunwald E, Morrow DA. Prognostic performance of multiple biomarkers in patients with non-ST-segment elevation acute coronary syndrome: analysis from the MERLIN-TIMI 36 trial (Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST-Elevation Acute Coronary Syndromes-Thrombolysis In Myocardial Infarction 36). J Am Coll Cardiol. 2014 Apr 29;63(16):1644-53. doi: 10.1016/j.jacc.2013.12.034. Epub 2014 Feb 13.
- Individual participant dataSharing planned: No. We will not share IPD to protect our data very well.
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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.
Zhaoqing Su, Doctor study chair
Shengjing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ST-elevation Myocardial Infarction, run by Shengjing Hospital 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 3 inclusion and 5 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 10 Mar 2017. 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 Tongtong Yu, Doctor (8602496615 ext. 22211, workhard31@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular events (MACE) (time frame: 6 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 NCT03074214, which also lists 2 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 10 Mar 2017.