About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 to 75 years. Angiographically confirmed coronary artery disease treated with successful percutaneous coronary intervention, defined as residual stenosis <30% with final TIMI grade 3 flow.
Disqualifiers
Severe valvular heart disease, cardiomyopathy, congenital heart disease, or other major structural heart disease.
Trial population
Adults aged 18 to 75 years with angiographically confirmed coronary artery disease who undergo successful percutaneous coronary intervention at participating cardiovascular centers and are clinically stable after the procedure. Participants must be able to provide reliable residential and occupational exposure histories for the 3 years preceding PCI and be eligible for baseline cardiovascular magnetic resonance and longitudinal echocardiographic follow-up.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Adverse Left Ventricular Remodeling at 6 Months
Adverse left ventricular remodeling will be defined as a ≥20% increase in left ventricular end-diastolic volume (LVEDV) from baseline to 6-month follow-up, measured by transthoracic echocardiography using the biplane Simpson method.
Sponsors and contacts
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Chinese PLA General Hospital
Lead sponsor
Affiliated Hospital of Qinghai University
Collaborator
First Affiliated Hospital of Harbin Medical University
Collaborator
Inner Mongolia People's Hospital
Collaborator