Effect of Recombinant Human Brain Natriuretic Peptide on Ventricular Remodeling and Cardiac Function in Patients With Acute Anterior Myocardial Infraction Undergoing Percutaneous Coronary Intervention

June 16, 2024 updated by: The First Affiliated Hospital with Nanjing Medical University
This study is designed to evaluate the efficacy and safety of Recombinant Human Brain Natriuretic Peptide (rhBNP) in improving ventricular remodeling and cardiac function after acute anterior myocardial infarction undergoing percutaneous coronary intervention. 100 patients with acute anterior myocardial infarction after primary Percutaneous Coronary Intervention (pPCI) are randomly assigned 1:1 to rhBNP group(n=50) and control group(n=50) with follow-up of 24 weeks. Both groups are treated with standard therapy of AAMI, with the rhBNP group intravenous dripping rhBNP after pPCI for 3 days and the control group treated with placebo at the same time. The primary endpoint is the change in N terminal pro-B-type natriuretic peptide（NT-proBNP ）and cardiac troponin T(cTnT) level.The secondary endpoint is the change in 24-week echocardiographic including left ventricle ejection fraction (LVEF) , left ventricular end-diastolic volume index (LVEDVI) and left ventricular end-systolic volume index (LVESVI), arrhythmia and cardiovascular events (death, cardiac arrest or cardiopulmonary resuscitation, hospitalization due to heart failure or angina pectoris).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • The First Affiliated Hospital of Nanjing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

People who are about 18 to 75 years old get the first acute anterior myocardial infarction ( AMI ) within 12 hours ( or more than 12 hours but the ischemic symptoms continue ) and undergo emergency PCI within the effective time window,after which the blood reflows ( TIMI = 3 ).

Description

Inclusion Criteria:

  1. The first acute anterior myocardial infarction ( AMI ) within 12 hours ( or more than 12 hours but the ischemic symptoms continue ).
  2. Age 18-75 years old, gender unlimited
  3. Patients with acute anterior myocardial infarction undergoing emergency PCI within the effective time window
  4. Successful reflow after interventional therapy ( TIMI = 3 ).
  5. To understand and sign the informed consent.

Exclusion Criteria：

  1. Patients with a history of coronary artery bypass grafting
  2. Patients with cardiogenic shock
  3. Patients with systolic blood pressure ( SBP ) ≤ 90 mmHg after treatment with vasopressors
  4. Patients with mechanical complications ( ventricular septal perforation, mitral chordae rupture )
  5. Patients with suspected aortic dissection
  6. Patients with severe liver and kidney dysfunction
  7. Allergic or intolerant to rhBNP.
  8. Patients with chronic renal insufficiency requiring long-term dialysis
  9. Patients using diuretics during the screening period
  10. Pregnant / lactating women
  11. Heart diseases that are not suitable for vasodilators, such as severe valve stenosis, restrictive cardiomyopathy, restrictive pericarditis, etc

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
patients who take Recombinant Human Brain Natriuretic Peptide
Drug: Recombinant Human Brain Natriuretic Peptide
we divide our subjects into two groups;one is required to take recombinant human brain natriuretic peptide,the other is not required to take recombinant human brain natriuretic peptide
patients who do not take Recombinant Human Brain Natriuretic Peptide

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ultrasonic cardiogram：left ventricle ejection fraction (LVEF)
Time Frame: from baseline to 6 months
LVEF refers to the percentage of stroke output to left ventricular end-diastolic
from baseline to 6 months
ultrasonic cardiogram：left ventricular end-diastolic volume index (LVEDVI)
Time Frame: from baseline to 6 months
LVEDVI（ml/m2）=left ventricular end-diastolic volume（ml）/body surface area
from baseline to 6 months
ultrasonic cardiogram：left ventricular end-systolic volume index (LVESVI)
Time Frame: from baseline to 6 months
LVESVI（ml/m2）=left ventricular end-systolic volume（ml）/body surface area
from baseline to 6 months
N terminal pro-B-type natriuretic peptide（NT-proBNP ）decline level
Time Frame: from baseline to 6 months
NT-proBNP is a protein which is an "ingredient" for making the BNP hormone and a sign of heart failure can be obteined by blood
from baseline to 6 months
The level of Cardiac Troponin T(cTnT)
Time Frame: from baseline to 6 months
The level of Cardiac Troponin T(cTnT) at 6 month
from baseline to 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Adverse cardiovascular events
Time Frame: from baseline to 6 months
from baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 3, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REBUILD-AAMI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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