Impact of a Coronary Artery Calcium-guided Primary Prevention of Major Coronary Heart Disease for Asymptomatic Coronary Artery Disease in Diabetes: a Prospective Cohort Study
Phase: NA
Conditions: Type2 Diabetes, Coronary Heart Disease
Sponsor: JuFeng, Hsiao

 
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Study protocol 
 
Title：Impact of a coronary artery calcium-guided primary prevention of 
major coronary heart disease for asymptomatic coronary artery disease in 
diabetes: a prospective cohort study 
PI: Meng-Huan Lei 
CO-PI: Ju-Feng Hsiao, Yu-Chen Hsu 
Affiliations 
Cardiovascular center, Lo-Tung Poh-Ai Hospital, Taiwan 
Version 2, 12/09/2021 
 
 

 
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Background 
The patients with type two diabetes mellites increased gradually and heart 
disease and cerebral vascular disease is the fourth leading cause of mortality. 
According to the National Health Insurance Research Database (NHIRD) till 
2014, incidence of coronary heart disease is 25.2% and heart failure is 
3.77%。Multiple complication including chronic kidney disease and 
cerebrovascular diseases were also well-known. 
A systematic review study of scientific evidence from across the world in 
2007-2017 revealed cardiovascular disease (CVD) affected 32.2% overall; 
29.1% had atherosclerosis, 21.2% had coronary heart disease (CAD), 14.9% 
heart failure, 14.6% angina, 10.0% myocardial infarction and 7.6% stroke. 
CVD representing 50.3% of all deaths is a major cause of mortality among 
people with type 2 Diabetes mellitus (T2DM) (1).A study in Asian population 
revealed patients with diabetes had a 1.89-fold risk of all-cause death and 
2.0-fold risk of cardiovascular death compared with patients without 
diabetes(2) . However, most diabetes with CAD are asymptomatic.  
Coronary artery calcium (CAC) score measured by multi-detector 
computerized tomography is a reliable measure of subclinical atherosclerosis. 

 
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The presence, extent and progression of CAC have been shown to predict 
adverse cardiovascular events better than traditional risk factors and global 
risk scoring (3-7)。Our previous study in 2020 revealed CAC score could 
predict long-term cardiovascular outcomes in asymptomatic patients with 
T2DM (8). 2019 AHA/ACC Guideline on the Primary Prevention of 
Cardiovascular Disease and 2019 ESC/EAS Guidelines for the management 
of dyslipidaemias recommend CAC score as a decision making aid for 
personalized risk management in primary prevention (9,10).This prospective 
cohort study will invest the impact of a coronary artery calcium-guided 
primary prevention of major coronary heart disease for asymptomatic 
coronary artery disease in T2DM. 
Objective 
To evaluate benefits of primary prevention of major coronary heart disease 
for asymptomatic coronary artery disease in T2DM based on the coronary 
artery calcium score 
Our proposal 
1. Based on CAC score, primary early prevention could reduce incidence of 
major coronary heart disease (CHD) including cardiac mortality, acute 
myocardial infarction, coronary revascularization 

 
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2.based on CAC score, primary early prevention could reduce all cause 
mortality, cardiac mortality, cardiovascular disease, heart failure, ischemic 
stroke, heart failure associated hospitalization and chronic kidney disease 
and related clinical cost effect. 
Method  
Population:  
The investigators will enroll 1500 asymptomatic T2DM patients who will 
receive Coronary artery calcium (CAC) imaging using 256 sliced multi-
detector computerized tomography (MDCT) scanner as research group and 
500 patients as control group from Lan-Yan Diabetes Shared Care Network 
(public health bureau, clinics, and regional hospital in Yilan County). 
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 

 
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Exclusion criteria: history of cardiovascular diseases such as coronary 
heart disease, stroke, heart failure etc, pregnant  
CAC Scores Measurement 
Coronary artery calcium (CAC) imaging was performed using an 256 sliced 
multi-detector computerized tomography (MDCT) scanner (Philips Brilliance 
256) equipped with high-resolution detectors.  
Intervention for study group 
Based on 2019 AHA/ACC Guideline on the Primary Prevention of 
Cardiovascular Disease and 2019 ESC/EAS Guidelines for the management 
of dyslipidemias and result of CAC score(9-12), the investigators will 
recommend the in-charged doctor to control the cardiovascular risk factors 
more aggressively. The study protocols are as follows 
If CAC score >0, Treadmill ECG or Thallium201 Scan would be arranged. If 
Treadmill ECG or Thallium201 show significant ischemia, further study such as 
CT angiography or coronary angiography will be arranged. 
If CAC score > 100， Aspirin 100mg QD will be suggested to decrease the 
cardiovascular risk in patients with low risk of bleeding. Previous studies 
revealed aspirin for patients with CAC score>100 at low bleeding risk 
indicated net benefit (13-17). 

 
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If CAC score > 400，statin therapy will be suggested to control lipidemia 
aggressively and target LDL level＜70 mg/dL (9-12)。 
The investigators will follow up these patients every 6 month, record their 
results of blood tests and medication for 5 years. Primary endpoint is major 
coronary heart disease including cardiac mortality, acute myocardial infarction 
and coronary revascularization. Second endpoint include all caused death, 
death due to cardiovascular disease, heart failure, stroke, admission for heart 
failure, chronic kidney disease and stroke, and cost related to AMI, coronary 
heart disease, heart failure, stroke, chronic kidney disease etc.  
Control group 
The investigators will enroll 500 age, gender, risk factor matched T2DM 
patient from our hospital. The doctor in charge will give usual care according 
to the Diabetes associate of Taiwan clinical 
practice guidelines for diabetes care. 
Reference 
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