An observational study in Coronary Artery Disease, Percutaneous Coronary Intervention (PCI) and Left Ventricular Remodeling, sponsored by Chinese PLA General Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Chinese PLA General Hospital · Observational
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.
Cold exposure has been associated with an increased risk of cardiovascular morbidity and mortality in population-based epidemiological studies. However, limited evidence is available regarding whether chronic cumulative exposure to cold environments is associated with myocardial structural and functional abnormalities or adverse prognosis among patients who have undergone coronary revascularization.
The COLD-PCI Study is a multicenter prospective observational cohort study designed to characterize the relationship between chronic cold-region exposure, cardiovascular imaging phenotypes, left ventricular remodeling, and subsequent cardiovascular outcomes after successful percutaneous coronary intervention.
The primary environmental exposure will be cumulative cold-region exposure during the 3 years preceding PCI. Exposure histories will be obtained using a standardized Cold Exposure History Questionnaire documenting residential, occupational, training/deployment, and relevant travel histories. Geographic locations will be coded at the county level. Months with at least 15 days of residence or work in a predefined cold region will be counted toward cumulative exposure.
Participants will be categorized into three exposure strata: no/minimal exposure (\<6 months), short-term exposure (6 to \<18 months), and long-term exposure (≥18 months). Objective meteorological exposure will additionally be assessed by linking participants' geographic histories to daily meteorological records and calculating the number of regional cold-wave days. Winter outdoor occupational exposure will also be quantified.
Baseline CMR will be performed approximately 7-14 days after PCI to characterize ventricular volumes and function, myocardial strain, left ventricular mass, myocardial infarct characteristics, microvascular obstruction, and other available myocardial tissue characteristics. Baseline transthoracic echocardiography will be performed within 3 days of CMR. Twelve-lead electrocardiographic parameters and routine demographic, clinical, angiographic, biochemical, and treatment variables will also be collected.
Follow-up echocardiography will be performed at 6 months. The primary outcome is adverse left ventricular remodeling, defined as an increase of at least 20% in left ventricular end-diastolic volume from baseline to the 6-month examination. Participants will additionally undergo longitudinal follow-up for major adverse cardiovascular events.
The study will examine associations between cumulative cold-region exposure and CMR phenotypes, evaluate potential imaging mediators of adverse ventricular remodeling, and assess whether cold-exposure variables improve prognostic prediction beyond conventional clinical, CMR, and electrocardiographic markers.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 400 is above the median of 320 across 1,687 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Chinese PLA General Hospital is the lead sponsor of 570 studies on the registry; 207 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 provided.
Exclusion Criteria:
Previous coronary artery bypass grafting or heart transplantation. End-stage heart failure or class IV heart failure. Severe renal dysfunction, defined as estimated \<30 mL/min/1.73 m².
Known 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with fewer than 6 cumulative months of cold-region exposure during the 3 years preceding PCI.
Participants with 6 to \<18 cumulative months of cold-region exposure during the 3 years preceding PCI.
Participants with 18 or more cumulative months of cold-region exposure during the 3 years preceding PCI.
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
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Chinese PLA General Hospital →