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Overview

TCTC

Despite the advance in medical care, cardiovascular diseases (CVD's) are among the leading causes of death in the world and represent an immense clinical, social, and economic burden.

CVD's and stroke are always the number 2 and 3 killers for Taiwanese population in recent years, and they really cost much from our medical resource. New diagnostic and therapeutic modalities have been vigorously developed to reduce the CV mortality and morbidity and have a big market. To achieve the above goals, it is important to conduct multicenter trials in a more efficient way by a clinical trial consortium. The major tasks of TCTC-CVD include:

1. To establish and maintain a clinical trial consortium for cardiovascular diseases in Taiwan, which can conduct standardized multi-center clinical trials for cardiovascular diseases, promote international academic communication and cooperation, hold international seminars, and provide international clinical trial information and the platform to share the resources and information of this consortium.

2. Through multi-center clinical trials to define the best diagnosis and treatment strategies for cardiovascular diseases.

3. To collect demographic data, clinical information, laboratory data, biological samples, and establish an electronic database, which can be used for basic research, clinical research, and a service platform for the biomedical industry.

Strengths

TCTC

Because CVD's are a group of disorders of the heart and blood vessels, including: coronary heart disease, cerebrovascular disease, peripheral arterial disease, valvular heart disease, congenital heart disease, deep vein thrombosis and pulmonary embolism, arrhythmia, and heart failure, etc., we have divided our PI and Co-PI's from 14 medical centers into 12 disease-specific branches according to their sub-specialties in CVD's. Each PI or Co-PI is in charge or co-charge of one branch to integrate and run the clinical trials in a more efficient way, respectively.

Each branch could also cooperate with other branches to run one trial if necessarily, to enroll the patients quicker and save the man-power and expense. The major tasks of the branch PI and Co-PI are not only to integrate and help the existing trials run by each PI invited by the Taiwanese CRO and to attract the international medical or pharmaceutical companies to run their clinical trials in Taiwan, but also and most importantly, to help the domestic medical or pharmaceutical companies to run their clinical trials and research/development of new products. The 12 branches include:

1. Arrhythmia and sudden cardiac death

2. Cardiovascular biosignature and cardiac oncology

3. Surgery for CVD’s and cardiorenal syndrome

4. Diabetes and cardiovascular disease

5. Heart failure, valvular heart disease and its intervention

6. Hypertension

7. Ischemic heart disease and its intervention

8. Lipid, atherosclerosis, and vascular dementia

9. Peripheral vascular diseases

10. Pulmonary artery hypertension and resuscitation/hypothermia

11. Thromboembolism, antiplatelets, and anticoagulants

12. Cardiovascular image and miscellaneous

Major Achievements

TCTC

International cooperation:

The trial " Semaglutide effects on cardiovascular outcomes in people with overweight or obesity (SELECT)」" performed by Dr. Chau-Chung Wu of the consortium, has completed the enrollment of a total of 17,500 people worldwide, and there have been 155 patients (15 more than expected) enrolled in Taiwan. The performance is very good, ranking second globally (Japan is the first). This trial mainly evaluates whether patients who are overweight or obese and have previously suffered from cardiovascular disease (including myocardial infarction, stroke and peripheral artery disease) can reduce cardiovascular events through the use of Semaglutide. Dr. Wu also participates in the operation of its Global Expert Panel (GEP). Although the Asian headquarters of Novo Nordisk is located in Mainland China, Mainland is unable to conduct such clinical trials due to relevant laws and regulations. Therefore, due to the Taiwan’s excellent performance in clinical trials, Novo Nordisk commissioned TCTC-CVD to lead this clinical trial in Taiwan to collect a larger amount of data of Chinese people. This case is of considerable help for the cultivation of relevant talents and international cooperation, and is one of sparks of the consortium.

Industry-academic-research orientation:

The “Application of Multi-channel ECG Signal Measurement and Analysis in Cardiovascular Diseases” performed by Dr. Chau-Chung Wu of this consortium has obtained the support from the National Seedling Program of Taiwan MOST. This instrument is the first one in the world to use resting ECG to diagnose stable coronary artery disease.

It is planned to help establish a biotech startup company, to create job opportunities and promote the development of related biotechnology industries.

Social impact:

TCTC-CVD has conducted more than 50 clinical trials, and the "Taiwan Dyslipidemia Primary and Secondary Prevention Registration Cohort Study" has been being run for 11 years. 14,323 cases have been enrolled. The information collected from this cohort has been used to understand the current status of domestic patients with hypertension and hyperlipidemia, which can provide evidence for designing medical policy. The results have also become an important reference for Taiwan to formulate blood lipid treatment guidelines.

On August 1, 2013, Taiwan National Health Insurance Administration (NHIA) revised the reimbursement standards for lipid-lowering drugs based on the data of this study; and the Taiwan Society of Lipid and Arteriosclerosis also revised the Taiwanese blood lipid treatment guidelines for ACS patients in 2017, and the THIA updated again on February 1, 2019, according to this treatment guideline, the lipid-lowering drug reimbursement standards for patients with ACS and CAD who have undergone interventional surgery. It is hoped that the number of cardiovascular events in Taiwan will be greatly reduced in the future, and related medical expenditures will be reduced.

Economic impact:

Through clinical trials initiated by researchers, patent acquisition and technology transfer, the members of this consortium have cooperated with the Academia Sinica, the National Health Administration, and several Foundations to assist domestic biotechnology manufacturers, such as TSH Biopharm., Golden Biotech., CCPC, MicroLife, Avita Co., MagQu Biotech., MAC BioMed., Power Biotech., WS Far IR Medical Technolog, etc., to RND their biotechnological products, which will have a significant impact on and contribution for the development of Taiwan’s biotechnology industry and the creation of employment opportunities. Considerable contribution and potential.

Members

TCTC

National Taiwan University HospitalNational Taiwan University Hospital (NTUH)

National Taiwan University Hospital (NTUH)

National Taiwan University Hospital (NTUH)

National Taiwan University Hospital (NTUH)

National Taiwan University Hospital (NTUH)

National Taiwan University Hospital (NTUH)

National Taiwan University Hospital (NTUH)

National Taiwan University Hospital (NTUH)

National Taiwan University Hospital (NTUH)

National Taiwan University Hospital (NTUH)

National Taiwan University Hospital (NTUH)

National Taiwan University Hospital (NTUH)

National Taiwan University Hospital (NTUH)

National Taiwan University Hospital (NTUH)

Taipei Veterans General Hospital (TVGH)

Taipei Veterans General Hospital (TVGH)

Taipei Veterans General Hospital (TVGH)

Tamsui MacKay Memorial Hospital (TMMH)

Tamsui MacKay Memorial Hospital (TMMH)

Hsinchu MacKay Memorial Hospital (CMMH)

Far Eastern Memorial Hospital (FEMH)

Far Eastern Memorial Hospital (FEMH)

Cheng Hsin General Hospital (Chgh)

Linkou Chang Gung Memorial Hospital (LCGMH)

Linkou Chang Gung Memorial Hospital (LCGMH)

China Medical University Hospital(CMUH)

China Medical University Hospital(CMUH)

National Cheng Kung University Hospital (NCKUH)

National Cheng Kung University Hospital (NCKUH)

National Cheng Kung University Hospital (NCKUH)

Chi Mei Medical Center

E-Da Hospital (EDAH)

E-Da Hospital (EDAH)

Kaohsiung Medical University Hospital (KMUH)

Kaohsiung Medical University Hospital (KMUH)

Hualien Tzu Chi Hospital (HTCH)

Taipei Veterans General Hospital

Contact Information

c-IRB

Lin-Hsun Chung

Email:r204.cc02@gmail.com

TEL:(02)23123456 ext #288559