NCT07773870Recruiting
Cold-Region Exposure and Cardiac Remodeling After PCI
Association of Cumulative Cold-Region Exposure With Left Ventricular Remodeling and Cardiovascular Outcomes After Percutaneous Coronary Intervention: A Multicenter Prospective Observational Cohort Study
Source: ClinicalTrials.gov · Last updated 19 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 16 Aug 2026
- Start date
- 30 Jun 2026
- Primary completion date
- 30 Dec 2027
- Lead sponsor
- Chinese PLA General Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT07773870
What you commit to
- Study type: Observational
- Planned participants: 400
- From 30 Jun 2026 to the primary completion date, 30 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chinese PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.