Coronary Artery DiseaseCOLD-PCINCT07773870
Cold-Region Exposure and Cardiac Remodeling After PCI
An observational study of Coronary Artery Disease and Percutaneous Coronary Intervention (PCI), run by Chinese PLA General Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Percutaneous Coronary Intervention (PCI), Left Ventricular Remodeling
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2026to 30 Dec 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Please Select An Option Below, 100048
XIN A, PhD, 13126526, 735147873@qq.com
About this study
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
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Coronary Artery Disease, Percutaneous Coronary Intervention (PCI), Left Ventricular Remodeling, Cold Exposure
- Keywords
- Left Ventricular Remodeling, Cardiac Magnetic Resonance Imaging, Cold Exposure, Acute Myocardial Infarction
- Medical subject headings
- Coronary Artery Disease, Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Minimal Cold-Region Exposure | Participants with fewer than 6 cumulative months of cold-region exposure during the 3 years preceding PCI. | |
| Cohort 2 Short-Term Cold-Region Exposure | Participants with 6 to <18 cumulative months of cold-region exposure during the 3 years preceding PCI. | |
| Cohort 3 Long-Term Cold-Region Exposure | Participants with 18 or more cumulative months of cold-region exposure during the 3 years preceding PCI. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 months after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start30 Jun 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Hospital of Qinghai University, First Affiliated Hospital of Harbin Medical University, Inner Mongolia People's Hospital
- Responsible party
- Principal investigator, XIN A, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773870
- Sponsor's protocol ID
- S2026-457-02
- Acronym
- COLD-PCI
- Status last verified
- Aug 2026
- First submitted
- 16 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07773870
- Acronym / sponsor ID
- COLD-PCI / S2026-457-02
- Conditions
- Coronary Artery Disease, Percutaneous Coronary Intervention (PCI), Left Ventricular Remodeling, Cold Exposure
- Keywords
- Left Ventricular Remodeling, Cardiac Magnetic Resonance Imaging, Cold Exposure, Acute Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Affiliated Hospital of Qinghai University, First Affiliated Hospital of Harbin Medical University, Inner Mongolia People's Hospital
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Minimal Cold-Region Exposure | – | –Participants with fewer than 6 cumulative months of cold-region exposure during the 3 years preceding PCI. |
| Cohort 2 Short-Term Cold-Region Exposure | – | –Participants with 6 to <18 cumulative months of cold-region exposure during the 3 years preceding PCI. |
| Cohort 3 Long-Term Cold-Region Exposure | – | –Participants with 18 or more cumulative months of cold-region exposure during the 3 years preceding PCI. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adverse Left Ventricular Remodeling at 6 Months
Time frame: Baseline to 6 months after PCI
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Percutaneous Coronary Intervention (PCI), run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Geng Qian, PhD (010499422, a2013346@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Left Ventricular Remodeling at 6 Months (time frame: Baseline to 6 months after PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.