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

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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 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


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

Value
https://center6.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
Registered date File name