UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024245
Receipt number R000027903
Scientific Title Stress myocardial perfusion CT during coronary CT exam
Date of disclosure of the study information 2016/09/30
Last modified on 2020/03/25 21:32:12

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Basic information

Public title

Stress myocardial perfusion CT during coronary CT exam

Acronym

The utility of stress myocardial CTP

Scientific Title

Stress myocardial perfusion CT during coronary CT exam

Scientific Title:Acronym

The utility of stress myocardial CTP

Region

Japan


Condition

Condition

apnea, myocardial infarction, diabetes mellitus, hypertension, dyslipidemia

Classification by specialty

Cardiology Endocrinology and Metabolism Radiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Myocardial ischemia and myocardial blood flow could be measured by adding stress dynamic myocardial CT perfusion to coronary CT angiography. The objective is to investigate the effect of these parameters on the prognosis and diagnosis of angina.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

MACE over a two-year period after the exam. Follow-up period might be extended when the event rate was lower than expected.

Key secondary outcomes

Assess patients who are eligible for stress myocardial CT perfusion.


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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Diabetes mellitus patients
2. If non-DM, patients with intermediate to high risk of coronary artery disease by Morise risk factor
3. Post percutaneous coronary intervention

Key exclusion criteria

1. Severe renal dysfunction
2. Active asthma
3. Allergy to contrast medium
4. Severe block

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Nobuo
Middle name
Last name Tomizawa

Organization

New Tokyo Hospital

Division name

Department of Radiology

Zip code

2702232

Address

1271 Wanagaya, Matsudo, Chiba

TEL

047-711-8700

Email

tomizawa-tky@umin.ac.jp


Public contact

Name of contact person

1st name Nobuo
Middle name
Last name Tomizawa

Organization

New Tokyo Hospital

Division name

Department of Radiology

Zip code

2702232

Address

1271 Wanagaya, Matsudo, Chiba

TEL

047-711-8700

Homepage URL


Email

tomizawa-tky@umin.ac.jp


Sponsor or person

Institute

New Tokyo Hospital

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

IRB of New Tokyo Hospital

Address

1271 Wanagaya, Matsudo, Chiba

Tel

+81477118700

Email

t-akutsu@sth-medical.co.jp


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



Other administrative information

Date of disclosure of the study information

2016 Year 09 Month 30 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

347

Results

1. Tomizawa N, Fujino Y, Kamitani M, et al. Longer diabetes duration reduces myocardial blood flow in remote myocardium assessed by dynamic myocardial CT perfusion. J Diabetes Complications. 2018 epub ahead of print

Results date posted

2020 Year 03 Month 25 Day

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

Completed

Date of protocol fixation

2016 Year 04 Month 01 Day

Date of IRB

2016 Year 02 Month 01 Day

Anticipated trial start date

2016 Year 04 Month 01 Day

Last follow-up date

2019 Year 05 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

None


Management information

Registered date

2016 Year 09 Month 30 Day

Last modified on

2020 Year 03 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027903


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name