Cold-Region Exposure and Cardiac Remodeling After PCI

Sponsor
Chinese PLA General Hospital
Study ID
NCT07773870
Status
Recruiting
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Conditions

  • Cold Exposure
  • Coronary Artery Disease
  • Left Ventricular Remodeling
  • Percutaneous Coronary Intervention (PCI)

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Study Details

This multicenter prospective observational cohort study aims to investigate the association between cumulative cold-region exposure and adverse left ventricular remodeling and cardiovascular outcomes in patients with coronary artery disease undergoing successful percutaneous coronary intervention (PCI). Individual-level chronic cold exposure will be quantified primarily by cumulative months of residence, work, or other relevant exposure in cold regions during the 3 years preceding PCI. Additional exposure measures will include regional cold-wave days derived from meteorological records and winter outdoor occupational exposure. Participants will undergo baseline cardiovascular magnetic resonance (CMR), echocardiography, electrocardiography, and clinical and laboratory assessment after PCI. Echocardiography will be repeated at 6 months to assess left ventricular remodeling. Cardiovascular events will be prospectively collected during follow-up. The study will evaluate whether cumulative cold-region exposure is associated with distinct CMR phenotypes, adverse left ventricular remodeling, and major adverse cardiovascular events (MACE), and whether cold-exposure measures provide incremental prognostic information beyond conventional clinical, imaging, and electrocardiographic risk markers.

Key Dates

First listed
Aug 19, 2026
Start date
Jun 30, 2026
Status verified
Aug 2026
Primary completion
Dec 30, 2027
Completion
Dec 30, 2028

Study Design

Enrollment
400 participants (estimated)

Arms

  • Arm: Cohort 1 Minimal Cold-Region Exposure
    Participants with fewer than 6 cumulative months of cold-region exposure during the 3 years preceding PCI.
  • Arm: Cohort 2 Short-Term Cold-Region Exposure
    Participants with 6 to \<18 cumulative months of cold-region exposure during the 3 years preceding PCI.
  • Arm: Cohort 3 Long-Term Cold-Region Exposure
    Participants with 18 or more cumulative months of cold-region exposure during the 3 years preceding PCI.

Primary Outcome Measure

Adverse Left Ventricular Remodeling at 6 Months [ Time Frame: Baseline to 6 months after PCI ]

Central Contacts

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