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Clinical Trials in China / NCT07773870
Recruiting Observational

Cold-Region Exposure and Cardiac Remodeling After PCI

NCT07773870 · tracked via the Priya Life Science China tracker
Sponsor
Chinese PLA General Hospital
Phase
Observational
Started
2026-06-30
Last updated
2026-08-19

Condition(s) studied

Coronary Artery DiseasePercutaneous Coronary Intervention (PCI)Left Ventricular RemodelingCold Exposure

Study summary

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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Clinically stable after PCI. Expected survival of at least 12 months. Able and willing to undergo baseline cardiovascular magnetic resonance imaging and baseline and 6-month transthoracic echocardiography. Able to provide residential, occupational, training/deployment, and other relevant exposure histories for the 3 years preceding PCI. Written informed consent provided. Exclusion Criteria: * Severe valvular heart disease, cardiomyopathy, congenital heart disease, or other major structural heart disease. Previous coronary artery bypass grafting or heart transplantation. End-stage heart failure or New York Heart Association class IV heart failure. Severe renal dysfunction, defined as estimated glomerular filtration rate \<30 mL/min/1.73 m². Known contraindication to cardiovascular magnetic resonance imaging or gadolinium-based contrast agents. Inability to complete transthoracic echocardiographic assessment. Inability to reliably recall or verify major residential or occupational exposure history during the 3 years preceding PCI. More than five major changes in primary residence during the 3 years preceding PCI that preclude reliable estimation of cumulative cold-region exposure.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Chinese PLA General Hospital Beijing Please Select An Option Below Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07773870 on ClinicalTrials.gov ↗ ← All trials in China