NCT07416344

A Coronary Computed Tomography Angiography-guided Intervention for High Risk Cardiovascular Disease Population in Rural China

A Coronary Computed Tomography Angiography-guided Intensive Intervention for Population at High Risk for Cardiovascular Disease in Rural China: a Cluster Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 14,980 (estimated)
• Sponsor: Harbin Medical University · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The CARDIAC trial is a prospective, parallel, open-label cluster randomized trial that aims to determine the effectiveness of a coronary computed tomography angiography (CTA)-guided intensive intervention strategy, as compared with standard care, on reducing the incidence of major adverse events (MACE) at 18 months among high-risk cardiovascular populations in rural China. An extended observational follow-up at 36 months will be conducted to further evaluate the effect on long-term clinical outcomes.

Detailed description

The CARDIAC trial aims to determine the effectiveness of a coronary CTA-guided intensive intervention strategy, as compared with standard care, on improving clinical outcomes among population at high risk for cardiovascular disease in rural China. This cluster randomized trial will be conducted in 428 rural villages in China. The study will recruit 35 individuals at high risk for cardiovascular disease from each village for a total of 14,980 participants. The participating villages will be randomly assigned to experimental group (CTA-guided group) and control group (standard care group) with 1:1 allocation. Study participants will be followed at 1, 3, 6, 12, and 18 months. The primary outcome is major adverse cardiovascular events (MACE, a composite of all-cause death, non-fatal myocardial infarction, and non-fatal stroke) at 18 months. In addition, an extended observational follow-up will be conducted at 36 months, to evaluate long-term outcomes (i.e., MACE).

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	CTA-guided Intensive Intervention Strategy	Intensive intervention strategies based on the result of coronary computed tomography angiography
OTHER	Comprehensive Intervention Strategy	Comprehensive intervention strategies based on guidelines and expert consensus

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-10-01
• Completion: 2030-04-01
• First posted: 2026-02-18
• Last updated: 2026-02-18

Locations

16 sites across 1 country: China