Acute Myocardial InfarctionPhase 4NCT04952259
Effect of Shexiang Tongxin Dropping Pills on Microcirculation in Patients With AMI
A Phase 4 study testing Shexiang Tongxin Dropping Pills + routine treatment and routine treatment in people with Acute Myocardial Infarction, run by Peking University Third Hospital.
Trial summary
This study is a randomized, controlled clinical trial. Evaluation of microcirculation resistance by index of microcirculation resistance to explore the protective effect of Shexiang Tongxin dripping pills on microcirculation in patients with acute anterior myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Shexiang Tongxin Dropping Pills + routine treatment and routine treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2021to 31 Jul 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old, no gender limit;
- Anterior wall STEMI within 12 hours of onset (diagnostic criteria: ischemic chest pain lasting ≥30min; ST-segment elevation or new left bundle branch block in two or more adjacent leads on the ECG; with or without Elevated myocardial markers), emergency PCI treatment is planned;
- Infarct-related coronary vascular anatomy is suitable for PCI treatment;
- Agree and cooperate to participate in this research, and sign an informed consent form
Who cannot join
- Past history of myocardial infarction history;
- The arteries related to infarction have received PCI in the past;
- Past CABG history;
- Killip grade of cardiac function ≥ grade III or cardiogenic shock;
- Systolic blood pressure ≤90mmHg;
- Bradycardia, heart rate <60 beats/min, or atrioventricular block of degree II or more;
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- Allergic to Shexiang Tongxin Dropping Pills
- Past history of asthma or severe COPD;
- Severe liver and kidney dysfunction;
- Participate in other clinical trials within 3 months;
- Pregnancy or breastfeeding.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the Effect of Shexiang Tongxin Dripping Pills on Coronary Microcirculation in Patients With Acute Anterior Myocardial Infarction by Microcirculation Resistance Index
This study is a randomized, controlled clinical trial. Evaluation of microcirculation resistance by index of microcirculation resistance to explore the protective effect of Shexiang Tongxin dripping pills on microcirculation in patients with acute anterior myocardial infarction.
Read the detailed description
Percutaneous coronary intervention (PCI) is the best way to improve the prognosis of patients with acute myocardial infarction (AMI), and ischemia-reperfusion injury (I/R) can damage the vascular endothelium through complex mechanisms, leading to microcirculation dysfunction and aggravation myocardial damage and affect the prognosis. Cell and animal experiments have proved that Shexiang Tongxin Dropping Pill has anti-inflammatory, anti-oxidant, reducing I/R damage, reducing infarct size, improving peripheral muscle microcirculation, and improving coronary slow blood flow, but it lacks directive evidences of improved coronary microcirculation in AMI patients. The microcirculation resistance index (IMR) is a parameter to evaluate the microcirculation state obtained by the pressure/temperature guidewire during PCI, which can accurately and quantitatively reflect the patient's coronary microcirculation state. In this study, patients with acute anterior wall elevation ST-segment myocardial infarction (STEMI) who were prospectively selected for direct PCI treatment were randomly divided into treatment group and control group. The treatment group was given Shexiang Tongxin Dropping Pills before PCI and received direct PCI treatment, the control group only received direct PCI treatment. The IMR of the two groups was detected immediately after PCI, and the differences in IMR values, myocardial injury markers and cardiac function parameters between the two groups were analyzed. It is hoped to prove that Shexiang Tongxin dripping pills have coronary microcirculation protection in acute anterior wall elevation ST-segment myocardial infarction with undergoing direct PCI treatment, and the effect is rapid, so as to provide a basis for optimizing AMI treatment strategies.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Shexiang Tongxin Dropping Pills + routine treatment, routine treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shexiang Tongxin Dropping Pills + routine treatmentDrug
Also called drugs and surgery
oral+percutaneous coronary intervention
routine treatmentProcedure or surgery
Also called surgery
percutaneous coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Shexiang Tongxin dripping pills + routine treatment Receives: Drug: Shexiang Tongxin Dropping Pills + routine treatment |
| Control group | Active comparator | routine treatment Receives: Procedure: routine treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
IMR
microcirculation resistance index
Measured: detected immediately after percutaneous coronary intervention
Secondary outcomes (1)
Myocardial injury markers
cardiac enzymes and troponin T
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start1 Aug 2021 (estimated)
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Jul 2023 (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 Peking University Third 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liyun He, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952259
- Sponsor's protocol ID
- M2019480
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2021
- Last updated
- 7 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Shexiang Tongxin Dripping Pills on Coronary Microcirculation in Patients With Acute Anterior Myocardial Infarction by Microcirculation Resistance Index
- ClinicalTrials.gov ID
- NCT04952259
- Acronym / sponsor ID
- M2019480
- Conditions
- Acute Myocardial Infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 7 Jul 2021 (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.
This study is a randomized, controlled clinical trial. Evaluation of microcirculation resistance by index of microcirculation resistance to explore the protective effect of Shexiang Tongxin dripping pills on microcirculation in patients with acute anterior myocardial infarction.
Detailed description
Percutaneous coronary intervention (PCI) is the best way to improve the prognosis of patients with acute myocardial infarction (AMI), and ischemia-reperfusion injury (I/R) can damage the vascular endothelium through complex mechanisms, leading to microcirculation dysfunction and aggravation myocardial damage and affect the prognosis. Cell and animal experiments have proved that Shexiang Tongxin Dropping Pill has anti-inflammatory, anti-oxidant, reducing I/R damage, reducing infarct size, improving peripheral muscle microcirculation, and improving coronary slow blood flow, but it lacks directive evidences of improved coronary microcirculation in AMI patients. The microcirculation resistance index (IMR) is a parameter to evaluate the microcirculation state obtained by the pressure/temperature guidewire during PCI, which can accurately and quantitatively reflect the patient's coronary microcirculation state. In this study, patients with acute anterior wall elevation ST-segment myocardial infarction (STEMI) who were prospectively selected for direct PCI treatment were randomly divided into treatment group and control group. The treatment group was given Shexiang Tongxin Dropping Pills before PCI and received direct PCI treatment, the control group only received direct PCI treatment. The IMR of the two groups was detected immediately after PCI, and the differences in IMR values, myocardial injury markers and cardiac function parameters between the two groups were analyzed. It is hoped to prove that Shexiang Tongxin dripping pills have coronary microcirculation protection in acute anterior wall elevation ST-segment myocardial infarction with undergoing direct PCI treatment, and the effect is rapid, so as to provide a basis for optimizing AMI treatment strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Shexiang Tongxin Dropping Pills + routine treatmentShexiang Tongxin dripping pills + routine treatment |
| Control group | Active comparator | Procedure: routine treatmentroutine treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years old, no gender limit;
- Anterior wall STEMI within 12 hours of onset (diagnostic criteria: ischemic chest pain lasting ≥30min; ST-segment elevation or new left bundle branch block in two or more adjacent leads on the ECG; with or without Elevated myocardial markers), emergency PCI treatment is planned;
- Infarct-related coronary vascular anatomy is suitable for PCI treatment;
- Agree and cooperate to participate in this research, and sign an informed consent form
Key exclusion criteria (11 listed)
- Past history of myocardial infarction history;
- The arteries related to infarction have received PCI in the past;
- Past CABG history;
- Killip grade of cardiac function ≥ grade III or cardiogenic shock;
- Systolic blood pressure ≤90mmHg;
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 |
|---|---|---|
| Shexiang Tongxin Dropping Pills + routine treatmentAlso: drugs and surgeryoral+percutaneous coronary intervention | Drug | Intervention group |
| routine treatmentAlso: surgerypercutaneous coronary intervention | Procedure or surgery | Control group |
Primary outcome
IMR
Time frame: detected immediately after percutaneous coronary intervention
microcirculation resistance index
1 secondary outcome
Myocardial injury markers
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Liyun He study director
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Shexiang Tongxin Dropping Pills + routine treatment and routine treatment in people with Acute Myocardial Infarction, run by Peking University Third Hospital.
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 4 inclusion and 11 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 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liyun He (+8613901132937, hly26@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IMR (time frame: detected immediately after percutaneous coronary intervention). 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 7 Jul 2021.