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

May 5, 2022 updated by: JuFeng, Hsiao

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

To evaluate benefits of primary prevention of major coronary heart disease for asymptomatic coronary artery disease in type 2 diabetes mellitus 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
  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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

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. 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
  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 investigator 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 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 investigator 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 ( If CAC score > 400，statin therapy will be suggested to control lipidemia aggressively and target LDL level<70 mg/dL The investigator 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, coronary revascularization. Second endpoint include all caused death, death due to cardiovascular disease, heart failure, stroke, admission for heart failure, chronic kidney disease and cost related to AMI, coronary heart disease, heart failure, stroke, chronic kidney disease etc.

Control group 500 age, gender, risk factor matched T2DM patients from our hospital will be enrolled. The doctor in charge will give usual care according to the Diabetes associate of Taiwan clinical practice guidelines for diabetes care.

Study Type

Interventional

Enrollment (Anticipated)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • YiLan, Taiwan, 26546
        • Lo-Tung Poh-Ai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: coronary artery calcium-guide

1500 asymptomatic T2DM patients who will receive Coronary artery calcium (CAC) imaging using 256 sliced multi-detector computerized tomography (MDCT) scanner 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 If CAC score > 400，statin therapy will be suggested to control lipidemia aggressively and target LDL level<70 mg/dL
Diagnostic test: Multi-Detector Computed Tomography
Coronary angiography calcium score via Multi-Detector Computed Tomography
No Intervention: usual care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of major coronary heart disease
Time Frame: 5-year followup
cardiac mortality, acute myocardial infarction and coronary revascularization
5-year followup

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of mortality
Time Frame: 5-year followup
all caused death, death due to cardiovascular disease, heart failure and stroke
5-year followup
rate of admission
Time Frame: 5-year followup
admission for heart failure, chronic kidney disease and stroke
5-year followup
medical expenditure
Time Frame: 5-year followup
Medical expenditure, including both inpatient and outpatient costs, the total medical cost of index hospitalization due to Medical expenditure based on Taiwan National Health Insurance Research Database within 5 year- followup, including both outpatient costs and the total medical cost of hospitalization related to AMI, coronary heart disease, heart failure, stroke, chronic kidney disease
5-year followup

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JuFeng, Hsiao

Collaborators

Lotung Poh-Ai Hospital

Investigators

  • Principal Investigator: Meng-Huan Lei, MD, cardiovascular center, Lo-Tung Poh-Ai Hospital, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Anticipated)

December 31, 2028

Study Completion (Anticipated)

December 31, 2028

Study Registration Dates

First Submitted

January 26, 2022

First Submitted That Met QC Criteria

March 1, 2022

First Posted (Actual)

March 7, 2022

Study Record Updates

Last Update Posted (Actual)

May 6, 2022

Last Update Submitted That Met QC Criteria

May 5, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB110-251-A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe