Effect of Nicorandil on Cardiac Sympathetic Nerve for the Patients of Acute ST Segment Elevation Myocardial Infarction

March 31, 2021 updated by: Xuzhou Central Hospital

Effects of Nicorandil on Cardiac Sympathetic Nerve Activity and Distribution in Patients With Acute Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention

The investigators evaluate the effects of intracoronary and intravenous administration of nicorandil on cardiac sympathetic nerve activity and distribution in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Reperfusion injury might occur in patients with acute ST segment elevation myocardial infarction undergoing the primary percutaneous coronary intervention(P-PCI),characterized by myocardial stunning, reperfusion-induced arrhythmia, microvascular dysfunction and injury of cardiac sympathetic nerve, etc.

Nicorandil is an antianginal agent with a dual mechanism of action: nitrate and K+ATP channel opener. The nitrate action causes vasodilation of systemic veins and epicardial coronary arteries, while the adenosine triphosphate (ATP)-sensitive potassium channel opener action causes vasodilation of peripheral and coronary resistance arterioles. Nicorandil not only decreases preload and afterload but also increases coronary blood flow.

The study will compare the effectiveness between nicorandil and placebo of preventing the reperfusion injury especially injury of cardiac sympathetic nerve in patients with acute ST segment elevation myocardial infarction undergoing the P-PCI.It is intended that before reperfusion injury ,nicorandil which was early used by intracoronary injection could prevent and release the microcirculatory spasm, release the coronary microvascular endothelial swelling,decrease embolism of atherosclerotic debris and thrombus formation,moreover,it could reduces the release of norepinephrine from sympathetic endings of the heart directly.So,it could decrease the phenomenon of no-reflow/slow reflow,reperfusion-induced arrhythmia and injury of cardiac sympathetic nerve.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

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

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

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. acute ST-segment elevation myocardial infarction within 12 hours of symptom onset;
  2. Age20-80,All genders
  3. anterior myocardial infarction
  4. The first myocardial infarction
  5. The infarct-related artery(IRA) is totally occlusive
  6. Blood pressure is higher than 90/60 millimeters of mercury（mmHg）
  7. The time from myocardial infarction onset to reach the hospital is less than 12 hs

Exclusion Criteria:

  1. kidney dysfunction (creatinine >2 mg/dl),
  2. History of previous liver disease,
  3. Cardiogenic shock,
  4. History of myocardial infarction (MI)
  5. History of coronary artery bypass grafting
  6. History of allergic response to drugs
  7. Severe hypovolemia

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nicorandil
Patients who received intracoronary and intravenous nicorandil before and after reperfusion with primary percutaneous coronary intervention
Drug: nicorandil
All patients received antiplatelet agents (aspirin, ticagrelor) and heparin.Diagnostic coronary angiography (CAG) was performed via the radial artery using the Seldinger method.The guidewire was passed into the culprit lesion.If the blood flow of culprit vessel reaches TIMI2-3 after balloon dilatation,6mg nicorandil was then administrated before stent implantation, A minimum 5-min interval occurred between the first and second doses of nicorandil to reduce adverse effects, subsequently , 6mg/h ivgtt. up to 48h after coronary intervention
Other Names:
  • Experiment Group
Placebo Comparator: Placebo （normal saline）
Patients who received intracoronary and intravenous placebo before and after reperfusion with primary percutaneous coronary intervention
Drug: Placebo（normal saline）
All patients received antiplatelet agents (aspirin, ticagrelor) and heparin.Diagnostic coronary angiography (CAG) was performed via the radial artery using the Seldinger method.The guidewire was passed into the culprit lesion.If the blood flow of culprit vessel reaches TIMI2-3 after balloon dilatation,6mg placebo was then administrated before stent implantation, A minimum 5-min interval occurred between the first and second doses of placebo to reduce adverse effects, subsequently , 6mg/h ivgtt. up to 48h after coronary intervention
Other Names:
  • Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the delayed heart/mediastinum count (H/M) ratio
Time Frame: 10 days after primary PCI
The delayed heart/mediastinum count (H/M) ratio was determined from 123I-meta-iodobenzylguanidine (MIBG) images
10 days after primary PCI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The total defect score (TDS)
Time Frame: 10 days after primary PCI
The total defect score was determined from 123I-meta-iodobenzylguanidine (MIBG) images
10 days after primary PCI
Rate of slow re-flow/no-reflow phenomenon
Time Frame: 5 minutes after primary PCI
TIMI myocardial perfusion grade (TMPG) of the final coronary flow in the culprit artery
5 minutes after primary PCI
Rate fo complete ST-segment resolution
Time Frame: 2 hours after primary PCI
ST-segment resolution >50 percent in ECG
2 hours after primary PCI
Rate of unplanned hospitalization for heart failure
Time Frame: 6 months after primary PCI
Rate of unplanned hospitalization for heart failure
6 months after primary PCI
The washout rate (WR)
Time Frame: 10 days after primary PCI
The washout rate (WR) were determined from 123I-meta-iodobenzylguanidine (MIBG) images
10 days after primary PCI
The total defect score (TDS)
Time Frame: 7 days after primary PCI
The total defect score was determined from 99mTc-pyrophosphate scintigraphy
7 days after primary PCI

Collaborators and Investigators

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

Sponsor

Xuzhou Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

April 1, 2021

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

February 1, 2022

Study Registration Dates

First Submitted

March 23, 2021

First Submitted That Met QC Criteria

March 31, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 31, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021KC20122

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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