UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Tight Heart Rate Control for Acute Aortic Dissection(THAAD-2):Multicenter Randomized Controlled Study in Patients with Type A Acute Aortic Intramural Hematoma
Title of the study (Brief title)	Tight Heart Rate Control for Type A Aortic Intramural Hematoma
Region	Japan

Condition
Condition	Type A Acute Aortic Intramural Hematoma
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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.

Base
Study type	Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Takashi Unoki
Organization	Saiseikai Kumamoto Hospital
Division name	Intensive Care Unit
Address	5-3-1 Chikami Minamiku Kumamoto, 861-4193 Japan
TEL	096-351-8000
Email	takashi-unoki@saiseikaikumamoto.jp

Public contact
Name of contact person	Takashi Unoki
Organization	Saiseikai Kumamoto Hospital
Division name	Intensive Care Unit
Address	5-3-1 Chikami Minamiku Kumamoto, 861-4193 Japan
TEL	096-351-8000
Homepage URL
Email	takashi-unoki@saiseikaikumamoto.jp

Sponsor
Institute	Saiseikai Kumamoto Hospital Intensive Care Unit
Institute
Department

Funding Source
Organization	Social Welfare Organization Saiseikai Imperial Gift Foundation, Inc.
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Saiseikai Matsuyama Hospital Saiseikai Futsukaichi Hospital Saiseikai Omuta Hospital Saiseikai Yokohamashi Tobu Hospital
Name of secondary funｄer(s)

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	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）

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 08 Month 06 Day
Last modified on	2019 Year 02 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017184