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Status unknownNCT05723315Updated Feb 10, 2023

Effect of rhBNP on CMD in Patients With STEMI After PPCI

An interventional study of recombinant human B-type natriuretic peptide in STEMI, sponsored by Henan Institute of Cardiovascular Epidemiology. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-02-10.

Sponsored by Henan Institute of Cardiovascular Epidemiology · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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 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.

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Conditions studied

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In context

ST Elevation Myocardial Infarction

688 studies on the registry are indexed under ST Elevation Myocardial Infarction; 184 are open to participants now.

This study's planned enrollment of 160 is below the median of 194 across 439 interventional studies indexed under ST Elevation Myocardial Infarction.

Browse ST Elevation Myocardial Infarction studies →

Lead sponsor

Henan Institute of Cardiovascular Epidemiology is the lead sponsor of 31 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • STEMI
  • PPCI within 24 hours of symptom onset
  • Target vessel QFR-MR>250mm Hg*s/m

Exclusion criteria

Exclusion Criteria:

  • claustrophobia
  • Postoperative TIMI grade 0-1
  • Pregnancy
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
160 participants (estimated)

Study arms

  • Experimental
    Experimental Group 1

    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).

    Drug: recombinant human B-type natriuretic peptide

  • No intervention
    Control Gruop

    The experimental group was given an intravenous infusion of the same amount of normal saline

Interventions

  • Drugrecombinant human B-type natriuretic peptide

    The recombinant human B-type natriuretic peptide produces physiological effects by imitating endogenous B-type natriuretic peptide

    Also known as: rhBNP

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What researchers measure

Primary outcomes

  1. MVO/LV(%)

    Microvascular obstruction assessed by magnetic resonance imaging

    Time frame: 3-14 days after PPCI

Secondary outcomes

  1. LGE/LV(%)

    Cardiac magnetic resonance imaging

    Time frame: 3-14 days and 90±7 days after PPCI

  2. IMH

    Intramuscular hemorrhageCardiac assessed by magnetic resonance imaging

    Time frame: 3-14 days after PPCI

  3. MVO/LV(%)

    Microvascular obstruction assessed by magnetic resonance imaging

    Time frame: 30±7 days after PPCI

  4. LVEDV(ml)

    Assessed by magnetic resonance imaging

    Time frame: 3-14 days and 90±7 days after PPCI

  5. LVESV(ml)

    Assessed by magnetic resonance imaging

    Time frame: 3-14 days and 90±7 days after PPCI

  6. Troponin (highest value)

    Troponin (highest value)

    Time frame: 3-14 days after PPCI

  7. MACCEs

    Major Adverse Cardiac and Cerebrovascular event:Death, nonfatal myocardial infarction, heart failure, revascularization, stroke

    Time frame: 7days,30days,3months,6 months

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2023; primary completion for Dec 2024, 22 months later.

Of 119 non-industry interventional studies with no phase under ST Elevation Myocardial Infarction, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 74. This study's planned 22 months is below that.

Counting every sponsor, half of 125 studies reached it within 38 months; a quarter within 19 and three quarters within 63.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 1, 2023
First posted
Feb 10, 2023
StartEst.
Feb 20, 2023
Primary completionEst.
Dec 20, 2024
CompletionEst.
Dec 20, 2025
Last update
Feb 10, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05723315
Lead sponsor
Henan Institute of Cardiovascular Epidemiology
Responsible party
Sponsor
First posted
Feb 10, 2023
Start date
Feb 20, 2023 (estimated)
Primary completion
Dec 20, 2024 (estimated)
Completion
Dec 20, 2025 (estimated)
Last update
Feb 10, 2023

Study contacts

Quan Guo
Contact
xinyiguoquan@163.com
+8615670510031
Muwei Li, MD
study chair · Fuwai central China cardiovascular hospotial

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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