UMIN-CTR Clinical Trial

Public title

Tight Heart Rate Control for Acute Aortic Dissection(THAAD-2):Multicenter Randomized Controlled Study in Patients with Type A Acute Aortic Intramural Hematoma

Acronym

Tight Heart Rate Control for Type A Aortic Intramural Hematoma

Scientific Title

Tight Heart Rate Control for Acute Aortic Dissection(THAAD-2):Multicenter Randomized Controlled Study in Patients with Type A Acute Aortic Intramural Hematoma

Scientific Title:Acronym

Tight Heart Rate Control for Type A Aortic Intramural Hematoma

Region

Japan

Condition

Type A Acute Aortic Intramural Hematoma

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Aortic dissection is a catastrophic cardiovascular disease associated with high morbidity and mortality.Blood pressure control using beta-adrenergic receptor blocker is widely accepted for treating type B acute aortic dissection.The goal is to lower systolic blood pressure to the lowest level commensurate with adequate vital organ perfusion, usually 100 to 120 mmHg. Although lowering heart rate is also thought to be important, the target setting of heart rate has not been well established. We have reported that tight heart rate control of less than 60bpm improved the outcome of medical treatment in patients with type B acute aortic dissection in the retrospective study.(Kodama K, Nishigami K et al. Tight heart rate control reduces secondary adverse events in patients with type B acute aortic dissection. Circulation 2008,118(14Suppl),167-170) Regarding type A aortic intramural hematoma (IMH), we have reported that medical treatment could apply to patients with type A acute aortic intramural hematoma in whom the maximul aortic diameter was less than 5cm and there was no ulcer like projection in the ascending aorta.(Kaji S, Nishigami K et al. Predicition of progression or regression of type A aortic intamural hematoma by computed tomography. Circulation 1999;100(suppl2):2-281-2-286.) The purpose of the present study was to validate tight heart rate control,less than 60bpm, reduced subsequent adverse events in patients with type A acute aortic intramural hematoma.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Survival rate and Aortic event:aortic rupture, The progression of aneurysm(>5mm/6 months), The requirement of surgical intervention including stent-grafting. These events will be determined to be based on the CT findings at admission, 1 week and 2 weeks after the admission, 1 month, 3 months, 6 months, 1 year, 1.5 years, 2 years after the discharge, and the occurence of aortic symptom.

Key secondary outcomes

The expansion rate of aortic diameter, The length of intensive care unit stay, The length of hospital stay, The agitation and delirium(scalling score), Hypoxia, (PaO2/FiO2 ratio), Acute kidney injury, The length of the required intra-venous anti-hypertensive medicine, sedative score.
Blood chemical examination: the count of white blood cell, red blood cell, and platelet, hemoglobin, hematocrit,prothrombin time, activated partial thromboplastin time, fibrinogen, fibrinogen degradation products, plasmin-alpha2 plasmin inhibitor complex, thrombin-antithorombin complex, D-dimmer, antithrombin three, total protein, albumin, total bilirubin, aspartate aminotransferase, alanine aminotransferase, gammma-glutamyl transpeptidase, lactate dehydrogenase, alkaline phosphatase, creatine phosphokinase, uric acid, blood urea nitrogen, creatinine, serum sodium, serum potassium, serum chloride, C-reactive protein, brain natriuretic peptide, catecholamine 3 fractionation, plasma renin activity,transforming growth factor-beta.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Dose comparison

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Heart rate control to < 60bpm using beta-blocker

Interventions/Control_2

Heart rate control to 60-80 bpm using beta-blocker

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

90

years-old

>

Gender

Male and Female

Key inclusion criteria

1)The admitted patient with type A acute aortic intramural hematoma within two days after the onset
2)The patient that the agreement by the sentence is provided having ability for agreement

Key exclusion criteria

1)Cardiac tamponade, Organ ischemia, >50mm in maximum aortic diameter,ulcer like projection in the ascending aorta
2)Contraindications of beta-blocker including bronchial asthama
3)Marfan syndrome
4)Shock vital including < 100mmHg in systolic blood pressure
5)The less than one year in survival prognosis due to malignancy et al
6)The participation in this study is not appropriate.

Target sample size

422

Name of lead principal investigator

1st name
Middle name
Last name	Takashi Unoki

Organization

Saiseikai Kumamoto Hospital

Division name

Intensive Care Unit

Zip code

Address

5-3-1 Chikami Minamiku Kumamoto, 861-4193 Japan

TEL

096-351-8000

Email

takashi-unoki@saiseikaikumamoto.jp

Name of contact person

1st name
Middle name
Last name	Takashi Unoki

Organization

Saiseikai Kumamoto Hospital

Division name

Intensive Care Unit

Zip code

Address

5-3-1 Chikami Minamiku Kumamoto, 861-4193 Japan

TEL

096-351-8000

Homepage URL

Email

takashi-unoki@saiseikaikumamoto.jp

Institute

Saiseikai Kumamoto Hospital Intensive Care Unit

Institute

Department

Personal name

Organization

Social Welfare Organization Saiseikai Imperial Gift Foundation, Inc.

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Saiseikai Matsuyama Hospital
Saiseikai Futsukaichi Hospital
Saiseikai Omuta Hospital
Saiseikai Yokohamashi Tobu Hospital

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

済生会熊本病院（熊本県）、済生会松山病院（愛媛県）、済生会二日市病院（福岡県）、済生会大牟田病院（福岡県）、済生会横浜市東部病院（神奈川県）

Date of disclosure of the study information

2014

Year

08

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2013

Year

10

Month

15

Day

Date of IRB

Anticipated trial start date

2014

Year

01

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

08

Month

06

Day

Last modified on

2019

Year

02

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017184