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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000013859
Receipt No. R000016168
Scientific Title The TRAC-SI (Triage of Acute Chest pain using Speckle tracking Imaging) trial
Date of disclosure of the study information 2014/05/01
Last modified on 2019/05/05

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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
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
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/ctr_e/ctr_view.cgi?recptno=R000016168

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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