Early rhBNP on Myocardial Work in Patients With STEMI

NCT ID: NCT04157868

Last Updated: 2019-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-30

Study Completion Date

2022-11-30

Brief Summary

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The study intends to evaluate the efficacy of early rhBNP on myocardial work in patients with anterior ST-segment elevation myocardial infarction after percutaneous coronary intervention

Detailed Description

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Conditions

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ST-Segment Elevated Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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rhBNP

rhBNP intra-coronary injection 1.5 ug/kg loading dose, with intravenous injection 0.0075-0.01 ug/kg/min persistent for 72 hour.

Group Type EXPERIMENTAL

rhBNP

Intervention Type DRUG

rhBNP intra-coronary injection 1.5 ug/kg loading dose, with intravenous injection 0.0075-0.01 ug/kg/min persistent for 72 hour.

Control

Saline intra-coronary injection 0.15ml/kg loading dose, with same intravenous injection speed for 72 hour after randomization.

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DRUG

Saline intra-coronary injection 0.15ml/kg loading dose, with same intravenous injection speed for 72 hour.

Interventions

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rhBNP

rhBNP intra-coronary injection 1.5 ug/kg loading dose, with intravenous injection 0.0075-0.01 ug/kg/min persistent for 72 hour.

Intervention Type DRUG

Control

Saline intra-coronary injection 0.15ml/kg loading dose, with same intravenous injection speed for 72 hour.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 1\. Anterior myocardial infarct (anterior myocardial infarct is defined as persistent chest pain for 30 mins at least, with ST-segment elevation of at least 0.2 mV in two or more contiguous precordial leads) within 12 hours after onsets of symptom;

2\. No contraindication for rhBNP;

3\. Left anterior descending (LAD) as culprit vessel, with TIMI 0-1 grade.

Exclusion Criteria

* 1.Cardiogenic shock (systolic BP \<90mmHg after fluid infusion or systolic BP\<100mmHg after vasoactive drugs);

2\. History of myocardial infarct;

3.Severe arrhythmia: with III degree A-V block ,atrial fibrillation,ventricular fibrillation,ventricular tachycardia;

4\. Any history of severe renal or hepatic dysfunction (hepatic failure, cirrhosis, portal hypertension or active hepatitis); neutropenia or thrombocytopenia; known acute pancreatitis;

5\. Pregnant or lactating;

6\. life expectancy≤12 months;

7\. Inability to follow the protocol and comply with follow-up requirements or any other reason the investigator feels would place the patient at increased risk;
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Song Ding, MD,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Central Contacts

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Song Ding, MD,Ph.D.

Role: CONTACT

86-21-68383477

References

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Reference Type BACKGROUND
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Wu GF, Wykrzykowska JJ, Rana JS, Pinto DS, Gibson CM, Li J, Sellke FW, Laham RJ. Effects of B-type natriuretic peptide (nesiritide) on coronary epicardial arteries, systemic vasculature and microvessels. J Invasive Cardiol. 2008 Feb;20(2):76-80.

Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Hubert A, Le Rolle V, Leclercq C, Galli E, Samset E, Casset C, Mabo P, Hernandez A, Donal E. Estimation of myocardial work from pressure-strain loops analysis: an experimental evaluation. Eur Heart J Cardiovasc Imaging. 2018 Dec 1;19(12):1372-1379. doi: 10.1093/ehjci/jey024.

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Reference Type BACKGROUND
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Boe E, Russell K, Eek C, Eriksen M, Remme EW, Smiseth OA, Skulstad H. Non-invasive myocardial work index identifies acute coronary occlusion in patients with non-ST-segment elevation-acute coronary syndrome. Eur Heart J Cardiovasc Imaging. 2015 Nov;16(11):1247-55. doi: 10.1093/ehjci/jev078. Epub 2015 Apr 6.

Reference Type BACKGROUND
PMID: 25851329 (View on PubMed)

Other Identifiers

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EARLY MYO-myocardial work

Identifier Type: -

Identifier Source: org_study_id

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