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

NCT04826497 | Unknown Phase 4 DMC

• 1 other identifier: 2021KC20122
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Coronary Heart Disease

Keywords

nicorandil; primary percutaneous coronary intervention; acute ST segment elevation myocardial infarction; cardiac sympathetic nerve

Outcome Measures

Primary Outcomes (1)

• Comparison of the delayed heart/mediastinum count (H/M) ratio

  The delayed heart/mediastinum count (H/M) ratio was determined from 123I-meta-iodobenzylguanidine (MIBG) images

  10 days after primary PCI

Secondary Outcomes (6)

• The total defect score (TDS)

  10 days after primary PCI

• Rate of slow re-flow/no-reflow phenomenon

  5 minutes after primary PCI

• Rate fo complete ST-segment resolution

  2 hours after primary PCI

• Rate of unplanned hospitalization for heart failure

  6 months after primary PCI

• The washout rate (WR)

  10 days after primary PCI

Study Arms (2)

Nicorandil

EXPERIMENTAL

Patients who received intracoronary and intravenous nicorandil before and after reperfusion with primary percutaneous coronary intervention

Drug: nicorandil

Placebo （normal saline）

PLACEBO COMPARATOR

Patients who received intracoronary and intravenous placebo before and after reperfusion with primary percutaneous coronary intervention

Drug: Placebo（normal saline）

Interventions

nicorandil DRUG

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

Also known as: Experiment Group

Nicorandil

Placebo（normal saline） DRUG

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

Also known as: Control Group

Placebo （normal saline）

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• kidney dysfunction (creatinine \>2 mg/dl),
• History of previous liver disease,
• Cardiogenic shock,
• History of myocardial infarction (MI)
• History of coronary artery bypass grafting
• History of allergic response to drugs
• Severe hypovolemia

Sponsors & Collaborators

• Xuzhou Central Hospital: lead

Related Publications (7)

• Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.

  PMID: 28886621 RESULT

• Piper HM, Meuter K, Schafer C. Cellular mechanisms of ischemia-reperfusion injury. Ann Thorac Surg. 2003 Feb;75(2):S644-8. doi: 10.1016/s0003-4975(02)04686-6.

  PMID: 12607706 RESULT

• Ji Z, Zhang R, Lu W, Ma G, Qu Y. The effect of nicorandil in patients with acute myocardial infarction undergoing percutaneous coronary intervention: a systematic review and meta-analysis. Ir J Med Sci. 2020 Feb;189(1):119-131. doi: 10.1007/s11845-019-02034-3. Epub 2019 May 30.

  PMID: 31147987 RESULT

• Xu L, Wang L, Li K, Zhang Z, Sun H, Yang X. Nicorandil prior to primary percutaneous coronary intervention improves clinical outcomes in patients with acute myocardial infarction: a meta-analysis of randomized controlled trials. Drug Des Devel Ther. 2019 Apr 29;13:1389-1400. doi: 10.2147/DDDT.S195918. eCollection 2019.

  PMID: 31118574 RESULT

• Fukui Y, Nozawa T, Ihori H, Sobajima M, Nakadate T, Matsuki A, Nonomura M, Fujii N, Inoue H, Kinugawa K. Nicorandil Attenuates Ischemia-Reperfusion Injury Via Inhibition of Norepinephrine Release From Cardiac Sympathetic Nerve Terminals. Int Heart J. 2017 Oct 21;58(5):787-793. doi: 10.1536/ihj.16-391. Epub 2017 Sep 30.

  PMID: 28966311 RESULT

• Kasama S, Toyama T, Kumakura H, Takayama Y, Ichikawa S, Suzuki T, Kurabayashi M. Effects of nicorandil on cardiac sympathetic nerve activity after reperfusion therapy in patients with first anterior acute myocardial infarction. Eur J Nucl Med Mol Imaging. 2005 Mar;32(3):322-8. doi: 10.1007/s00259-004-1672-0. Epub 2004 Oct 2.

  PMID: 15791442 RESULT

• Hicks KA, Mahaffey KW, Mehran R, Nissen SE, Wiviott SD, Dunn B, Solomon SD, Marler JR, Teerlink JR, Farb A, Morrow DA, Targum SL, Sila CA, Thanh Hai MT, Jaff MR, Joffe HV, Cutlip DE, Desai AS, Lewis EF, Gibson CM, Landray MJ, Lincoff AM, White CJ, Brooks SS, Rosenfield K, Domanski MJ, Lansky AJ, McMurray JJV, Tcheng JE, Steinhubl SR, Burton P, Mauri L, O'Connor CM, Pfeffer MA, Hung HMJ, Stockbridge NL, Chaitman BR, Temple RJ; Standardized Data Collection for Cardiovascular Trials Initiative (SCTI). 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials. J Am Coll Cardiol. 2018 Mar 6;71(9):1021-1034. doi: 10.1016/j.jacc.2017.12.048.

  PMID: 29495982 RESULT

MeSH Terms

Conditions

Coronary Disease; ST Elevation Myocardial Infarction

Interventions

Nicorandil; Control Groups

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Nitrates; Organic Chemicals; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Institute of Cardiovascular Disease Xuzhou Central Hospital

  Southeast University

  STUDY DIRECTOR

Central Study Contacts

chunguang Feng, PhD

CONTACT

+8618936376559; fcg999@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: April 1, 2021
• Study Start: April 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: February 1, 2022
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share