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Search / Trial NCT05267990

Coronary Artery Calcium-guided Primary Prevention of Major Coronary Heart Disease in Asymptomatic Diabetes

Launched by JUFENG, HSIAO · Mar 1, 2022

Trial Information

Current as of November 10, 2025

Enrolling by invitation

Keywords

Coronary Artery Calcium Score Type 2 Diabetes Coronary Heart Disease

ClinConnect Summary

This trial is asking whether using a heart artery scan to guide prevention can lower the chance of having major heart problems in people with type 2 diabetes who don’t yet have heart symptoms. In Taiwan, about 2,000 adults will be divided into two groups: 1,500 will get a coronary artery calcium (CAC) scan and a treatment plan tailored to their CAC score, while 500 will receive usual diabetes care. The study will follow participants for up to 5 years to see how many experience major heart events (like heart death, heart attack, or procedures to open blocked arteries) and also look at other outcomes such as death from any cause, stroke, heart failure, hospital visits, kidney disease, and costs.

Who can join? Adults aged 40 and older with type 2 diabetes and at least one heart risk factor—such as high cholesterol, high blood pressure, smoking, a family history of early heart disease, or protein in the urine—may be eligible. People with a history of heart disease, stroke, or heart failure are not eligible. In the CAC-guided group, everyone gets the CAC scan; if the score is above 0, additional heart tests may be booked. If the CAC score is above 100, aspirin 100 mg daily may be suggested; if it’s above 400, stronger cholesterol-lowering treatment to reach LDL below 70 mg/dL may be suggested. Participants have check-ins about every 6 months for up to 5 years. The study is based at Lo-Tung Poh-Ai Hospital in YiLan, Taiwan, and is currently enrolling.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • more than 40 years old T2DM patients have any one cardiovascular risk as follows
  • 1. total cholesterol\>200mg/dl or low density lipoprotein (LDL) \>100mg/dl
  • 2. blood pressure\>140/90mm/Hg or taking anti-hypertension agents
  • 3. history of smoking
  • 4. family history of early coronary heart diseases
  • 5. proteinuria
  • Exclusion Criteria:
  • history of cardiovascular diseases such as coronary heart disease, stroke, heart failure etc, pregnant

About Jufeng, Hsiao

Jufeng Hsiao is a dedicated clinical trial sponsor committed to advancing medical research and innovation. With a focus on developing cutting-edge therapies, Jufeng Hsiao collaborates with healthcare professionals and institutions to conduct rigorous clinical trials that adhere to the highest ethical and scientific standards. The organization prioritizes patient safety and data integrity, utilizing state-of-the-art methodologies to ensure robust and reliable outcomes. Through its comprehensive approach to trial management, Jufeng Hsiao aims to contribute significantly to the healthcare landscape, facilitating the development of effective treatments that address unmet medical needs.

Locations

Yilan, Taiwan

Patients applied

0 patients applied

Trial Officials

Meng-Huan Lei, MD

Principal Investigator

cardiovascular center, Lo-Tung Poh-Ai Hospital, Taiwan

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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