Percutaneous Coronary Intervention (PCI) Clinical Trials

Clinical trials related to Percutaneous Coronary Intervention (PCI) Procedure

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

Status: Recruiting
Location: See location...
Study Type: Observational
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). 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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Chinese PLA General Hospital
RECRUITING
Beijing
Contact Information
Primary
Geng Qian, PhD
a2013346@hotmail.com
010499422
Time Frame
Start Date: 2026-06-30
Estimated Completion Date: 2028-12-30
Participants
Target number of participants: 400
Treatments
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.
Sponsors
Collaborators: Affiliated Hospital of Qinghai University, First Affiliated Hospital of Harbin Medical University, Inner Mongolia People's Hospital
Leads: Chinese PLA General Hospital

This content was sourced from clinicaltrials.gov