UMIN-CTR Clinical Trial

Basic information
Public title	The TRAC-SI (Triage of Acute Chest pain using Speckle tracking Imaging) trial
Acronym	The TRAC-SI trial
Scientific Title	The TRAC-SI (Triage of Acute Chest pain using Speckle tracking Imaging) trial
Scientific Title:Acronym	The TRAC-SI trial
Region	Japan

Condition
Condition	Acute coronary syndrome
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the usefulness of resting 2D speckle tracking echocardiography in the triage of patients with acute coronary syndrome (ACS) who visit the emergency department complaining of chest pain. (To determine whether strain analysis using 2D speckle tracking echocardiography improves the initial diagnosis of ACS in patients with chest pain who visit the emergency department.)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Using the final diagnosis of ACS (truth standard) as the true value (sick or healthy), sensitivity is assessed for each of the three protocols: (1) combination of initial diagnosis and 2D speckle tracking echocardiography (Index + 2DST method), (2) initial diagnosis alone (Index method), and (3) 2D speckle tracking echocardiography alone (2DST method).
Key secondary outcomes	specificity, positive predictive value, and negative predictive value of above.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who visit the emergency department with a chief symptom of chest pain (newly onset, rest onset, and/or worsening) for 24 hours or less and are judged to meet all of the following conditions by the attending physician are enrolled in this trial. 1) Patients who are 20 years of age or older on the day informed consent is obtained (no upper age limit) 2) Patients with no significant ST elevation or abnormal Q waves on ECG 3) Patients with no systolic wall motion abnormalities
Key exclusion criteria	Patients who meet any one of the following conditions are excluded from the trial. 1) Patients who show signs of moderate congestive heart failure (NYHA III or higher) 2) Patients who are in shock 3) Patients with LVEF less than 50% 4) Patients with left bundle branch block 5) Patients with a history of myocardial infarction or other myocardial disease 6) Patients with valvular heart disease for which invasive treatment is judged to be necessary 7) Patients in whom acceptable ultrasound images cannot be obtained 8) Patients who are found to have abnormal cardiac wall contraction by echocardiography 9) Patients with atrial fibrillation 10) Patients with a heart rate of 40 bpm or less or 100 bpm or higher 11) Patients with a serum creatinine level of 2.0 or higher 12) Patients with a history of allergy to contrast medium 13) Patients who are pregnant or breastfeeding, patients who may be pregnant 14) Patients who should be excluded from the trial for medical reasons, based on the judgment of their attending physician
Target sample size	403

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Ishii, Katsuhisa
Organization	Kansai Electric Power Hospital
Division name	Department of Cardiology
Zip code
Address	2-1-7 Fukushima, Fukushima-ku, Osaka-shi 553-0003
TEL	06-6458-5821
Email	ishii.katsuhisa@b2.kepco.co.jp

Public contact
1st name of contact person	1st name Middle name Last name Hyodo, Eiichi
Organization	Nishinomiya Watanabe Cardiovascular Center
Division name	Division of Cardiology
Zip code
Address	3-25, Ikedachyo, Nishinomiya City, Hyogo, Japan 662-0911
TEL	0798-36-1880
Homepage URL
Email	ehyodo47@gmail.com

Sponsor
Institute	Department of Cardiology, Kansai Electric Power Hospital
Institute
Department

Funding Source
Organization	Toshiba Medical Systems
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions

Institutions

Mayoクリニック　　　　　　　　　　　　　　　　　 Jae K. Oh 西宮渡辺心臓血管センター　　　　　　　　　　　　　吉川純一、兵頭永一 島根大学医学部附属病院　　　　　　　　　　　　　　田邊一明 東京ベイ・浦安市川医療センター・ハートセンター　　渡辺弘之 東京大学附属病院　　　　　　　　　　　　　　　　　大門雅夫、川田貴之 和歌山県立医科大学附属病院　　　　　　　　　　　　赤阪隆史、田中篤、平田久美子 筑波大学附属病院　　　　　　　　　　　　　　　　　瀬尾由広、石津智子 東住吉森本病院　　　　　　　　　　　　　　　　　　宮崎知奈美 東京医科大学附属病院　　　　　　　　　　　　　　　田中信大、武井康悦 手稲渓仁会病院　　　　　　　　　　　　　　　　　　村上弘則 杏林大学医学部附属病院　　　　　　　　　　　　　　坂田好美 九州大学医学部付属病院　　　　　　　　　　　　　　　有田武史 東京女子医科大学附属病院　　　　　　　　　　　　　新井光太郎 紀南病院　　　　　　　　　　　　　　　　　　　　　木村桂三

Other administrative information
Date of disclosure of the study information	2014 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 03 Month 21 Day
Date of IRB	2014 Year 09 Month 02 Day
Anticipated trial start date	2014 Year 03 Month 22 Day
Last follow-up date	2017 Year 09 Month 30 Day
Date of closure to data entry	2019 Year 05 Month 05 Day
Date trial data considered complete	2019 Year 05 Month 05 Day
Date analysis concluded	2019 Year 05 Month 05 Day

Other

Other related information

This is an open-label trial, but the analysis of images acquired using 2D speckle tracking echocardiography by the core laboratories should be conducted in a blinded manner. 1) Initial diagnosis ACS-positive patients should be defined based on the ECG and troponin values 1. Among the 16 left ventricular segments, 4 segments in the apical region and 6 segments in the basal region are excluded from analysis, and only the segments in the mid region are analyzed. The peak systolic strain value (%), time to peak strain, SIDI, and post systolic index are measured in each of the coronary artery territories (average of mid anterior septum and mid anterior wall for the anterior descending branch, mid inferior wall for the right coronary artery, and mid lateral wall for the circumflex branch). Apical-approach three-plane images are used for analysis of longitudinal strain, while short-axis images at the papillary muscle level are used for analysis of radial strain and circumferential strain. 2. Among the 16 left ventricular segments, 6 segments in the basal region are excluded from analysis, and only the segments in the apical and mid regions are analyzed. The peak systolic strain value (%), time to peak strain, SIDI, and post systolic index are measured in the territory of each coronary artery (average of apical and mid anterior septum and apical and mid anterior wall for the anterior descending branch, mid inferior wall for the right coronary artery, and mid lateral wall for the circumflex branch). Apical-approach three-plane images are used for analysis of longitudinal strain, while short-axis images at the papillary muscle level are used for analysis of radial strain and circumferential strain.

Management information
Registered date	2014 Year 05 Month 01 Day
Last modified on	2019 Year 05 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016168