UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026437
Receipt number R000030370
Scientific Title Prospective surveillance of patients with developing chronic pulmonary thromboembolism and chronic thromboembolic pulmonary hypertension after occurring acute pulmonary thromboembolism
Date of disclosure of the study information 2017/04/01
Last modified on 2023/03/12 11:08:29

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Basic information

Public title

Prospective surveillance of patients with developing chronic pulmonary thromboembolism and chronic thromboembolic pulmonary hypertension after occurring acute pulmonary thromboembolism

Acronym

Prospective surveillance of patients with developing chronic pulmonary thromboembolism and chronic thromboembolic pulmonary hypertension after occurring acute pulmonary thromboembolism

Scientific Title

Prospective surveillance of patients with developing chronic pulmonary thromboembolism and chronic thromboembolic pulmonary hypertension after occurring acute pulmonary thromboembolism

Scientific Title:Acronym

Prospective surveillance of patients with developing chronic pulmonary thromboembolism and chronic thromboembolic pulmonary hypertension after occurring acute pulmonary thromboembolism

Region

Japan


Condition

Condition

acute pulmonary thromboembolism

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the developing risk of chronic pulmonary thromboembolism and chronic thromboembolic pulmonary hypertension after ocurring acute pulmonary thromboembolism

Basic objectives2

Others

Basic objectives -Others

Prognosis of acute pulmonary thromboembolism

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The developing risk of chronic pulmonary thromboembolism and chronic thromboembolic pulmonary hypertension after one year ocurring acute pulmonary thromboembolism

Key secondary outcomes

1) developing risk of chronic pulmonary thromboembolism
2) developing risk of chronic thromboembolic pulmonary hypertension
3) recurrence of symptomatic acute pulmonary embolism
4)all cause death, cardiovascular death, non-cardiovascular death
5) incidence of bleeding
6) comparison of baseline characteristics
7) comparison among the treatments
8) trend of coagulation markers


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

16 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) patients with acute symptomatic pulmonary thromboembolism diagnosed by pulmonary arterial contrast enhanced CT, pulmonary angiography or ventilation/perfusion lung scan.
2) 16 years-old or older
3) obtained informed consent from patient

Key exclusion criteria

1) contrast medium allergy
2) eGFR lower than 30 mL/min/1.73m2
3) pregnancy

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Shiro
Middle name
Last name Adachi

Organization

Nagoya University Hospital

Division name

Department of Cardiology

Zip code

466-8560

Address

65 Tsurumai-cho, Shouwa-ku, Nagoya , Japan

TEL

+81-52-744-2150

Email

takahisa@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name Yoshihisa
Middle name
Last name Nakano

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Cardiology

Zip code

466-8560

Address

65 Tsurumai-cho, Shouwa-ku, Nagoya , Japan

TEL

+81-52-744-2150

Homepage URL


Email

okumura0607@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya University Graduate School of Medicine, Department of Cardiology

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Human Research Ethics Committees of Nagoya University Hospital

Address

65 Tsurumai-cho, Shouwa-ku, Nagoya , Japan

Tel

052-744-2423

Email

ethics@med.nagoya-u.ac.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

2017 Year 04 Month 01 Day


Related information

URL releasing protocol

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9303750/

Publication of results

Partially published


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9303750/

Number of participants that the trial has enrolled

52

Results

Fifty-two patients were enrolled. Two patients(3.8%)developed chronic thromboembolic pulmonary hypertension. A total of 43 patients completed evaluation at 1 year, among whom (74%) had residual thrombi, with a median modified CT obstruction index (mCTOI) of 10.7%. The tricuspid regurgitation pressure gradient 60 mmHg or over and left ventricular end-diastolic dimension at diagnosis were significantly related to mCTOI at 1 year.

Results date posted

2022 Year 09 Month 10 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

patients with acute pulmonary thromboembolism

Participant flow

patients diagnosed with acute PE were recruited and examinations were conducted at 1 month, 6 months, and 1 year. Especially at 1 year, patients were evaluated multifacetedly, including by laboratory tests, quality-of-life, 6-min walking test, and enhanced CT.

Adverse events

All cause death was obsreved in two patients, and major bleeding in two patients.

Outcome measures

residual thrombi one year after acute pulmonary thromboembolism

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 01 Month 01 Day

Date of IRB

2017 Year 03 Month 16 Day

Anticipated trial start date

2017 Year 04 Month 01 Day

Last follow-up date

2020 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2022 Year 12 Month 31 Day


Other

Other related information

none


Management information

Registered date

2017 Year 03 Month 07 Day

Last modified on

2023 Year 03 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030370


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name