UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014779
Receipt No. R000017184
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
Date of disclosure of the study information 2014/08/06
Last modified on 2017/06/14

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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 Enrolling by invitation
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
2017 Year 06 Month 14 Day


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


Contact us.