Myocardial InfarctionPhase 4SF-STEMINCT02709798
ShenFu Injection for Myocardial Protection in Patients With Acute ST Segment Elevation Myocardial Infarction
A Phase 4 study testing Shenfu Injection and 5% Glucose Injection in people with Myocardial Infarction, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate whether perioperative use of Shenfu Injection could reduce myocardial injury (enzymatic infarct size and infarct volume according to cardiac magnetic resonance imaging) in patients with STEMI after primary PCI Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Shenfu Injection and 5% Glucose Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to Feb 2018
- Phase
- Phase 4
- 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
Who may be able to join
- Age ≥18 and <75 years;
- First-time acute anterior STEMI;
- The time from onset of ischemic symptom to the time of initial PCI balloon inflation ≤6 hours;
- >0.1 mV ST segment elevation in at least two contiguous precordial leads according to electrocardiogram;
- Scheduled for primary PCI;
- The presence of left anterior descending branch (LAD) occlusion in proximal or middle segment with pre-PCI TIMI flow 0 or 1 according to baseline coronary angiogram;
- Written informed consent.
Who cannot join
- Hypertrophic cardiomyopathy, aortic valve stenosis and/or regurgitation, pericarditis, or myocarditis;
- Cardiogenic shock, severe ventricular arrhythmia, serious heart failure (Killip class III and above) or mechanical complications;
- Patients after cardiopulmonary resuscitation (CPR) (including cardioversion);
- Patients who have already received thrombolytic therapy;
- Prior myocardial infarction or coronary artery bypass surgery;
- Known serious hepatic, renal, blood, respiratory, or neuropsychiatric diseases;
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- Malignant tumor, lymphoma, HIV-positive, or hepatitis;
- Uncontrolled hypertension (systolic BP >160 mm Hg or a diastolic BP >100 mmHg on at least two consecutive readings);
- Patients with active bleeding, major surgery or trauma within 3 months and cerebrovascular accident within 6 months;
- History of anemia (hemoglobin<90g/L) or thrombocytopenia (thrombocyte<90×109/L);
- Multi-vessel disease with non-culprit vessel intervention;
- Breastfeeding, pregnant, or potentially fertile women;
- Patients who have known to be allergic to Shenfu Injection or its components or patients with serious adverse effect;
- Patients with potential contraindication to CMR;
- Participation in other clinical trial in recent 3 months;
- Patients who cannot complete this trial or comply with the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Effect of Shenfu Injection on Reperfusion Injury in Patients With Acute ST Segment Elevation Myocardial Infarction After Primary Percutaneous Coronary Intervention: A Pilot Trial
The purpose of this study is to evaluate whether perioperative use of Shenfu Injection could reduce myocardial injury (enzymatic infarct size and infarct volume according to cardiac magnetic resonance imaging) in patients with STEMI after primary PCI
- Conditions
- Myocardial Infarction
- Being tested
- Shenfu Injection, 5% Glucose Injection
- Keywords
- Shenfu Injection, Reperfusion Injury, Myocardial Protection, Percutaneous Coronary Intervention
- Medical subject headings
- Myocardial Infarction, Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shenfu InjectionDrug
Also called Shenfu Zhusheye
5% Glucose InjectionDrug
| Study group | Role | What they receive |
|---|---|---|
| Shenfu Injection | Experimental | 80ml Shenfu Injection + 70ml 5% glucose injection), ivdrip, 30 minutes before PCI and 1-5 days (once a day) after PCI (6 times in total). Drug titration time should be no less than 30 minutes. Receives: Drug: Shenfu Injection |
| 5% Glucose Injection | Placebo comparator | 150 ml 5% glucose injection, ivdrip, 30 minutes before PCI and 1-5 days (once a day) after PCI (6 times in total). Drug titration time should be no less than 30 minutes. Receives: Drug: 5% Glucose Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infarct size
Infarct size was assessed by measuring the area under the curve (AUC) of creatine kinase isoenzyme (CK-MB) within 72 hours after PCI and by performing cardiac magnetic resonance (CMR) imaging at 4±1days after PCI.
Measured: immediately after admission (0 hour), and 6, 12, 18, 24, 48, and 72 hours after PCI, as well as 4±1days after PCI
Secondary outcomes (5)
AUC of cardiac troponin I (cTnI)
Measured: immediately after admission (0 hour), and 6, 12, 18, 24, 48, and 72 hours after PCI
Peak value of CK-MB and cTnI
Measured: 72 hours after PCI
ST segment resolution (%) according to ECG
Measured: up to 24 hours after PCI
Left ventricular end-diastolic diameter (LVEDD), left ventricular end-systolic diameter (LVESD), and Left ventricular ejection fraction (LVEF)
Measured: up to 28 days after PCI
Main adverse cardiovascular and cerebrovascular events (MACCE, including death, non-fatal myocardial infarction, target vessel revascularization, stroke, new-onset severe heart failure, re-hospitalization for heart failure)
Measured: up to 28 days after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Shao-Ping Nie, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02709798
- Sponsor's protocol ID
- D99-2015(043)-TCM-4
- Acronym
- SF-STEMI
- Status last verified
- Aug 2018
- First submitted
- 11 Mar 2016
- Last updated
- 7 Aug 2018
- Results posted
- No
Publications
Wang X, Miao H, Yan Y, Guo R, Gong W, He Y, Wang H, Ma X, Nie S. Effect of Shenfu Injection on Reperfusion Injury in Patients Undergoing Primary Percutaneous Coronary Intervention for ST Segment Elevation Myocardial Infarction: A Pilot Randomized Clinical Trial. Front Cardiovasc Med. 2021 Dec 3;8:736526. doi: 10.3389/fcvm.2021.736526. eCollection 2021.
PubMed 34926601
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Effect of Shenfu Injection on Reperfusion Injury in Patients With Acute ST Segment Elevation Myocardial Infarction After Primary Percutaneous Coronary Intervention: A Pilot Trial
- ClinicalTrials.gov ID
- NCT02709798
- Acronym / sponsor ID
- SF-STEMI / D99-2015(043)-TCM-4
- Conditions
- Myocardial Infarction
- Keywords
- Shenfu Injection, Reperfusion Injury, Myocardial Protection, Percutaneous Coronary Intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Collaborators
- China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.
- Study start
- Apr 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 16 Mar 2016 (estimated)
- 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.
The purpose of this study is to evaluate whether perioperative use of Shenfu Injection could reduce myocardial injury (enzymatic infarct size and infarct volume according to cardiac magnetic resonance imaging) in patients with STEMI after primary PCI
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shenfu Injection | Experimental | Drug: Shenfu Injection80ml Shenfu Injection + 70ml 5% glucose injection), ivdrip, 30 minutes before PCI and 1-5 days (once a day) after PCI (6 times in total). Drug titration time should be no less than 30 minutes. |
| 5% Glucose Injection | Placebo comparator | Drug: 5% Glucose Injection150 ml 5% glucose injection, ivdrip, 30 minutes before PCI and 1-5 days (once a day) after PCI (6 times in total). Drug titration time should be no less than 30 minutes. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 and <75 years;
- First-time acute anterior STEMI;
- The time from onset of ischemic symptom to the time of initial PCI balloon inflation ≤6 hours;
- >0.1 mV ST segment elevation in at least two contiguous precordial leads according to electrocardiogram;
- Scheduled for primary PCI;
Key exclusion criteria (16 listed)
- Hypertrophic cardiomyopathy, aortic valve stenosis and/or regurgitation, pericarditis, or myocarditis;
- Cardiogenic shock, severe ventricular arrhythmia, serious heart failure (Killip class III and above) or mechanical complications;
- Patients after cardiopulmonary resuscitation (CPR) (including cardioversion);
- Patients who have already received thrombolytic therapy;
- Prior myocardial infarction or coronary artery bypass 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 |
|---|---|---|
| Shenfu InjectionAlso: Shenfu Zhusheye | Drug | Shenfu Injection |
| 5% Glucose Injection | Drug | 5% Glucose Injection |
Primary outcome
Infarct size
Time frame: immediately after admission (0 hour), and 6, 12, 18, 24, 48, and 72 hours after PCI, as well as 4±1days after PCI
Infarct size was assessed by measuring the area under the curve (AUC) of creatine kinase isoenzyme (CK-MB) within 72 hours after PCI and by performing cardiac magnetic resonance (CMR) imaging at 4±1days after PCI.
5 secondary outcomes
AUC of cardiac troponin I (cTnI)
Time frame: immediately after admission (0 hour), and 6, 12, 18, 24, 48, and 72 hours after PCI
Peak value of CK-MB and cTnI
Time frame: 72 hours after PCI
ST segment resolution (%) according to ECG
Time frame: up to 24 hours after PCI
Left ventricular end-diastolic diameter (LVEDD), left ventricular end-systolic diameter (LVESD), and Left ventricular ejection fraction (LVEF)
Time frame: up to 28 days after PCI
Main adverse cardiovascular and cerebrovascular events (MACCE, including death, non-fatal myocardial infarction, target vessel revascularization, stroke, new-onset severe heart failure, re-hospitalization for heart failure)
Time frame: up to 28 days after PCI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Derived from this study: PubMed 34926601Wang X, Miao H, Yan Y, Guo R, Gong W, He Y, Wang H, Ma X, Nie S. Effect of Shenfu Injection on Reperfusion Injury in Patients Undergoing Primary Percutaneous Coronary Intervention for ST Segment Elevation Myocardial Infarction: A Pilot Randomized Clinical Trial. Front Cardiovasc Med. 2021 Dec 3;8:736526. doi: 10.3389/fcvm.2021.736526. eCollection 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Shenfu Injection and 5% Glucose Injection in people with Myocardial Infarction, run by Beijing Anzhen 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 7 inclusion and 16 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: finished, as of the sponsor's last update on 7 Aug 2018. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infarct size (time frame: immediately after admission (0 hour), and 6, 12, 18, 24, 48, and 72 hours after PCI, as well as 4±1days after PCI). 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 NCT02709798, which also lists 1 linked publication.
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 7 Aug 2018.