UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013859 |
|---|---|
| Receipt number | 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 10:03:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
ehyodo47@gmail.com
Sponsor or person
Institute
Department of Cardiology, Kansai Electric Power Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016168
