STEMINCT05723315
Effect of rhBNP on CMD in Patients With STEMI After PPCI
A study testing recombinant human B-type natriuretic peptide in people with STEMI, run by Henan Institute of Cardiovascular Epidemiology.
Trial summary
The target population of this interventional study was STEMI patients. Primary discussion: Early rhBNP reduces microcirculation obstruction in STEMI patients undergoing primary PCI Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- STEMI
- What is being tested?
- recombinant human B-type natriuretic peptide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2023to 20 Dec 2025
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- STEMI
- PPCI within 24 hours of symptom onset
- Target vessel QFR-MR>250mm Hg*s/m
Who cannot join
- claustrophobia
- Postoperative TIMI grade 0-1
- Pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of rhBNP on Coronary Microcirculation in Patients With Acute ST-segment Elevation Myocardial Infarction After Primary PCI
The target population of this interventional study was STEMI patients. Primary discussion: Early rhBNP reduces microcirculation obstruction in STEMI patients undergoing primary PCI
Read the detailed description
Direct percutaneous coronary intervention is the preferred reperfusion strategy for acute ST-segment elevation myocardial infarction. During the opening of infarct-related vessels, 5%-50% of patients showed slow flow or no reflow and other coronary microcirculation dysfunction, which aggravated myocardial injury and increased the incidence and mortality of heart failure. Studies have shown that recombinant human brain natriuretic peptide (rhBNP) can reduce reperfusion injury and reduce myocardial infarction area CMD. Prolonged ischemia leads to rapid depletion of intracellular ATP and tissue metabolic acidosis. Blood flow irrigation during reperfusion leads to decreased levels of ATP precursors, calcium overload in mitochondria, release of a large number of inflammatory factors and oxygen free radicals, which can lead to injury or death of myocardial and endothelial cells. rhBNP can enhance the activity of antioxidant enzymes, reduce the irreversible oxidative damage caused by free radicals to myocardium, reduce the myocardial infarction area during ischemia reperfusion, and may reduce the reperfusion injury and protect the viable myocardium.
- Conditions
- STEMI
- Being tested
- recombinant human B-type natriuretic peptide
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant human B-type natriuretic peptideDrug
Also called rhBNP
The recombinant human B-type natriuretic peptide produces physiological effects by imitating endogenous B-type natriuretic peptide
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group 1 | Experimental | The experimental group was given neoptin within 3h after PCI for 72 hours (first at 1.5μg /kg intravenous load, then at 0.015μg /kg/min). Receives: Drug: recombinant human B-type natriuretic peptide |
| Control Gruop | No intervention | The experimental group was given an intravenous infusion of the same amount of normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
MVO/LV(%)
Microvascular obstruction assessed by magnetic resonance imaging
Measured: 3-14 days after PPCI
Secondary outcomes (7)
LGE/LV(%)
Cardiac magnetic resonance imaging
Measured: 3-14 days and 90±7 days after PPCI
IMH
Intramuscular hemorrhageCardiac assessed by magnetic resonance imaging
Measured: 3-14 days after PPCI
MVO/LV(%)
Microvascular obstruction assessed by magnetic resonance imaging
Measured: 30±7 days after PPCI
LVEDV(ml)
Assessed by magnetic resonance imaging
Measured: 3-14 days and 90±7 days after PPCI
LVESV(ml)
Assessed by magnetic resonance imaging
Measured: 3-14 days and 90±7 days after PPCI
Troponin (highest value)
Troponin (highest value)
Measured: 3-14 days after PPCI
MACCEs
Major Adverse Cardiac and Cerebrovascular event：Death, nonfatal myocardial infarction, heart failure, revascularization, stroke
Measured: 7days，30days，3months，6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start20 Feb 2023 (estimated)
- Primary completion20 Dec 2024 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMIStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Institute of Cardiovascular Epidemiology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muwei Li, MD, Study chair, Fuwai central China cardiovascular hospotial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723315
- Sponsor's protocol ID
- HenanICE202301
- Status last verified
- Feb 2023
- First submitted
- 1 Feb 2023
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of rhBNP on Coronary Microcirculation in Patients With Acute ST-segment Elevation Myocardial Infarction After Primary PCI
- ClinicalTrials.gov ID
- NCT05723315
- Acronym / sponsor ID
- HenanICE202301
- Conditions
- STEMI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Henan Institute of Cardiovascular EpidemiologyUniversity, hospital or other
- Study start
- 20 Feb 2023 (estimated)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 10 Feb 2023 (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.
The target population of this interventional study was STEMI patients. Primary discussion: Early rhBNP reduces microcirculation obstruction in STEMI patients undergoing primary PCI
Detailed description
Direct percutaneous coronary intervention is the preferred reperfusion strategy for acute ST-segment elevation myocardial infarction. During the opening of infarct-related vessels, 5%-50% of patients showed slow flow or no reflow and other coronary microcirculation dysfunction, which aggravated myocardial injury and increased the incidence and mortality of heart failure. Studies have shown that recombinant human brain natriuretic peptide (rhBNP) can reduce reperfusion injury and reduce myocardial infarction area CMD. Prolonged ischemia leads to rapid depletion of intracellular ATP and tissue metabolic acidosis. Blood flow irrigation during reperfusion leads to decreased levels of ATP precursors, calcium overload in mitochondria, release of a large number of inflammatory factors and oxygen free radicals, which can lead to injury or death of myocardial and endothelial cells. rhBNP can enhance the activity of antioxidant enzymes, reduce the irreversible oxidative damage caused by free radicals to myocardium, reduce the myocardial infarction area during ischemia reperfusion, and may reduce the reperfusion injury and protect the viable myocardium.
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 |
|---|---|---|
| Experimental Group 1 | Experimental | Drug: recombinant human B-type natriuretic peptideThe experimental group was given neoptin within 3h after PCI for 72 hours (first at 1.5μg /kg intravenous load, then at 0.015μg /kg/min). |
| Control Gruop | No intervention | –The experimental group was given an intravenous infusion of the same amount of normal saline |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- STEMI
- PPCI within 24 hours of symptom onset
- Target vessel QFR-MR>250mm Hg*s/m
Key exclusion criteria (3 listed)
- claustrophobia
- Postoperative TIMI grade 0-1
- Pregnancy
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 |
|---|---|---|
| recombinant human B-type natriuretic peptideAlso: rhBNPThe recombinant human B-type natriuretic peptide produces physiological effects by imitating endogenous B-type natriuretic peptide | Drug | Experimental Group 1 |
Primary outcome
MVO/LV(%)
Time frame: 3-14 days after PPCI
Microvascular obstruction assessed by magnetic resonance imaging
7 secondary outcomes
LGE/LV(%)
Time frame: 3-14 days and 90±7 days after PPCI
IMH
Time frame: 3-14 days after PPCI
MVO/LV(%)
Time frame: 30±7 days after PPCI
LVEDV(ml)
Time frame: 3-14 days and 90±7 days after PPCI
LVESV(ml)
Time frame: 3-14 days and 90±7 days after PPCI
Troponin (highest value)
Time frame: 3-14 days after PPCI
MACCEs
Time frame: 7days，30days，3months，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 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for STEMI
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Incremental Prognostic Utility of CBC-derived Inflammatory Indices After Incomplete Coronary Revascularization: Association With 12-months Cardiovascular Outcomes
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Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
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.
Muwei Li, MD study chair
Fuwai central China cardiovascular hospotial
Questions about this trial
What is this clinical trial studying?
A study testing recombinant human B-type natriuretic peptide in people with STEMI, run by Henan Institute of Cardiovascular Epidemiology.
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 3 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 Feb 2023. 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.
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 Quan Guo (+8615670510031, xinyiguoquan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MVO/LV(%) (time frame: 3-14 days after PPCI). 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 10 Feb 2023.