NCT05267990

Brief Summary

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. 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. 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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Mar 2022Dec 2028

First Submitted

Initial submission to the registry

January 26, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2022

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

May 6, 2022

Status Verified

May 1, 2022

Enrollment Period

6.8 years

First QC Date

January 26, 2022

Last Update Submit

May 5, 2022

Conditions

Type2 DiabetesCoronary Heart Disease

Keywords

coronary artery calcium scoretype 2 diabetescoronary heart disease

Outcome Measures

Primary Outcomes (1)

  • rate of major coronary heart disease

    cardiac mortality, acute myocardial infarction and coronary revascularization

    5-year followup

Secondary Outcomes (3)

  • rate of mortality

    5-year followup

  • rate of admission

    5-year followup

  • medical expenditure

    5-year followup

Study Arms (2)

coronary artery calcium-guide

ACTIVE COMPARATOR

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

usual care

NO INTERVENTION

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.

Interventions

Multi-Detector Computed TomographyDIAGNOSTIC_TEST

Coronary angiography calcium score via Multi-Detector Computed Tomography

coronary artery calcium-guide

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • more than 40 years old T2DM patients have any one cardiovascular risk as follows
  • total cholesterol\>200mg/dl or low density lipoprotein (LDL) \>100mg/dl
  • blood pressure\>140/90mm/Hg or taking anti-hypertension agents
  • history of smoking
  • family history of early coronary heart diseases
  • proteinuria

You may not qualify if:

  • history of cardiovascular diseases such as coronary heart disease, stroke, heart failure etc, pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lo-Tung Poh-Ai Hospital

Yilan, 26546, Taiwan

Location

MeSH Terms

Conditions

Coronary DiseaseDiabetes Mellitus, Type 2

Interventions

Multidetector Computed Tomography

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Tomography, Spiral ComputedTomography, X-Ray ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomography

Study Officials

  • Meng-Huan Lei, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: a prospective cohort study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

January 26, 2022

First Posted

March 7, 2022

Study Start

March 1, 2022

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

May 6, 2022

Record last verified: 2022-05

Locations

TW(1)