Cold-Region Exposure and Cardiac Remodeling After PCI

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorChinese PLA General Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

400 Participants
are grouped into 3 trial groups
Group A: Cohort 1 Minimal Cold-Region Exposure
Group B: Cohort 2 Short-Term Cold-Region Exposure
Group C: Cohort 3 Long-Term Cold-Region Exposure

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline to 6 months after PCI

Secondary outcomes

Other outcomes

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