The Effect of Nicorandil on Left Ventricular Myocardial Strain in Patients With Coronary Chronic Total Occlusion
1 other identifier
interventional
61
1 country
1
Brief Summary
Background Nicorandil is recommended as a second-line treatment for stable angina, but randomized-controlled trials (RCTs) to evaluate the benefit of nicorandil for patients with chronic total occlusion (CTO) are still lack. Objective To determine whether nicorandil can improve left ventricular myocardial strain in patients with CTO. Methods Patients with CTO were included and were randomized to the nicorandil group and the control group. Nicorandil was given orally 15 mg/day for 3 months in the nicorandil group. 3-dimentional-speckle tracking echocardiography (3D-STE) and the Seattle angina questionnaire (SAQ) survey were performed at baseline and at 3 months. Participants were randomized according to an IBM SPSS23.0-generated randomization schedule, with a 1:1 allocation to the nicorandil group or the control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 coronary-artery-disease
Started Apr 2019
Shorter than P25 for phase_4 coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 8, 2020
CompletedFirst Submitted
Initial submission to the registry
October 10, 2021
CompletedFirst Posted
Study publicly available on registry
October 21, 2021
CompletedOctober 21, 2021
October 1, 2021
1.3 years
October 10, 2021
October 10, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
total area strain
3 months
Study Arms (2)
nicorandil group
EXPERIMENTALcontrol group
NO INTERVENTIONInterventions
Patients in the nicorandil group were also given nicorandil (Tohoku Nipro Pharmaceutical Corporation, Japan) orally 5 mg three times per day for 3 months
Eligibility Criteria
You may qualify if:
- age between 18 and 80 years;1 or more CTO vessels (≥2mm in diameter)
You may not qualify if:
- successful PCI for all CTO lesions; ST segment elevation myocardial infarction (STEMI) during the past 3 months; planed coronary artery bypass grafting (CABG) within 3 months; valvular heart disease or congenital heart disease; cardiomyopathy; heart failure with NYHA (New York Heart Association) class III or above; persistent atrial fibrillation or complete left bundle branch block; severe liver, kidney, or lung diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Related Publications (1)
Chen S, Ma C, Feng X, Cui M. Nicorandil Improves Left Ventricular Myocardial Strain in Patients With Coronary Chronic Total Occlusion. Front Cardiovasc Med. 2022 May 12;9:864223. doi: 10.3389/fcvm.2022.864223. eCollection 2022.
PMID: 35647043DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ming cui, doctor
Peking University Third Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2021
First Posted
October 21, 2021
Study Start
April 8, 2019
Primary Completion
July 8, 2020
Study Completion
July 8, 2020
Last Updated
October 21, 2021
Record last verified: 2021-10