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

Sponsor
Harbin Medical University
Study ID
NCT07416344
Status
Enrolling By Invitation

Conditions

  • Coronary Artery Disease

Eligibility Criteria

Sex
ALL
Age
40 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Feb 18, 2026
Start date
Apr 27, 2026
Status verified
Jun 2026
Primary completion
Oct 31, 2028
Completion
Apr 30, 2030

Study Design

Enrollment
14,980 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: CTA-guided Group
    CTA-guided intensive intervention strategy (participants will have their treatment recommendations based on the result of CTA examination)
  • Active Comparator: Standard Care Group
    Standard comprehensive intervention strategy

Primary Outcome Measure

MACE [ Time Frame: 18 months ]

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