Unique ID issued by UMIN | UMIN000014779 |
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Receipt number | R000017184 |
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 |
Date of disclosure of the study information | 2014/08/06 |
Last modified on | 2019/02/08 16:57:12 |
Tight Heart Rate Control for Acute Aortic Dissection(THAAD-2):Multicenter Randomized Controlled Study in Patients with Type A Acute Aortic Intramural Hematoma
Tight Heart Rate Control for Type A Aortic Intramural Hematoma
Tight Heart Rate Control for Acute Aortic Dissection(THAAD-2):Multicenter Randomized Controlled Study in Patients with Type A Acute Aortic Intramural Hematoma
Tight Heart Rate Control for Type A Aortic Intramural Hematoma
Japan |
Type A Acute Aortic Intramural Hematoma
Cardiology |
Others
NO
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.
Safety,Efficacy
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.
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.
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Dose comparison
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine |
Heart rate control to < 60bpm using beta-blocker
Heart rate control to 60-80 bpm using beta-blocker
20 | years-old | <= |
90 | years-old | > |
Male and Female
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
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.
422
1st name | |
Middle name | |
Last name | Takashi Unoki |
Saiseikai Kumamoto Hospital
Intensive Care Unit
5-3-1 Chikami Minamiku Kumamoto, 861-4193 Japan
096-351-8000
takashi-unoki@saiseikaikumamoto.jp
1st name | |
Middle name | |
Last name | Takashi Unoki |
Saiseikai Kumamoto Hospital
Intensive Care Unit
5-3-1 Chikami Minamiku Kumamoto, 861-4193 Japan
096-351-8000
takashi-unoki@saiseikaikumamoto.jp
Saiseikai Kumamoto Hospital Intensive Care Unit
Social Welfare Organization Saiseikai Imperial Gift Foundation, Inc.
Non profit foundation
Japan
Saiseikai Matsuyama Hospital
Saiseikai Futsukaichi Hospital
Saiseikai Omuta Hospital
Saiseikai Yokohamashi Tobu Hospital
NO
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)
2014 | Year | 08 | Month | 06 | Day |
Unpublished
Completed
2013 | Year | 10 | Month | 15 | Day |
2014 | Year | 01 | Month | 01 | Day |
2014 | Year | 08 | Month | 06 | Day |
2019 | Year | 02 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017184
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