Clinical trial Recruiting at 1 site Observational Ages 18 to 80

Cold-region exposure and heart remodeling after PCI

Official title: Association of Cumulative Cold-Region Exposure With Left Ventricular Remodeling and Cardiovascular Outcomes After Percutaneous Coronary Intervention: A Multicenter Prospective Observational Cohort Study

Run by Chinese PLA General Hospital · NCT07773870 · Data updated 2026-11-12

This study tests whether long-term cold exposure before PCI is linked to worse heart remodeling and outcomes in people with coronary artery disease.

Quick facts

Study typeObservational
Ages18 Years to 80 Years
SexAll
Enrollment400 (estimated)
SponsorChinese PLA General Hospital
Academic / other
Locations1 site (Beijing, Please Select An Option Below)
StatusRecruiting
StartedJune 30, 2026
Main results expectedDecember 30, 2027
Study endsDecember 30, 2028
Registry record updatedAugust 19, 2026
Trial IDNCT07773870 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18–75 who had angiographically confirmed CAD and a successful PCI, are clinically stable, can undergo baseline and 6-month imaging, and can provide 3-year exposure histories.

Probably not a fit

Patients outside the geographic regions studied or those unable to undergo baseline or follow-up imaging may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective observational cohort study will examine if cumulative cold-region exposure prior to PCI is associated with adverse left ventricular remodeling and cardiovascular events after successful PCI. Researchers will quantify cold exposure through residence and work in cold regions over the 3 years before PCI, plus meteorological and outdoor work data. Participants will have baseline CMR, echocardiography, ECG, and clinical labs, with a 6-month echo follow-up to assess remodeling and ongoing capture of cardiovascular events. The study aims to link imaging phenotypes with environmental exposure to understand potential prognostic implications. Interventions are not part of this observational design.

Why it matters

Potential benefit: If associations are found, patients may benefit from more tailored monitoring and risk stratification based on cold-exposure history.

How similar studies have gone: Previous population studies suggest cold exposure affects cardiovascular risk, but data in post-PCI patients are limited, making this approach relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Chinese PLA General Hospital
    Beijing, Please Select An Option Below, China
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.