- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06262971
Left Main Percutaneous Coronary Intervention Registry in Istanbul Medipol University Hospital
February 15, 2024 updated by: Ozgur Ulas Ozcan, Medipol University
Comprehensive Registry of Left Main Coronary Artery Percutaneous Coronary Intervention Outcomes at Istanbul Medipol University Hospital
This hospital-based registry study at Istanbul Medipol University Hospital focuses on documenting and analyzing the clinical and demographic characteristics, procedural-related aspects, and both short and long-term outcomes of patients undergoing left main coronary artery percutaneous coronary intervention (PCI).
The study aims to identify predictors for adverse clinical outcomes in patients treated for left main coronary artery disease.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
3620
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Istanbul, Turkey
- Istanbul Medipol University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
All patients performing any PCI procedure(s) in given timeframe will be included in this registry
Description
Inclusion Criteria:
- All patients undergoing any PCI procedure(s) in given timeframe will be included in this registry
Exclusion Criteria:
- Patients with no informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Major Adverse Cardiac Events (MACE) within One Year Following Left Main Coronary Artery PCI
Time Frame: up to 1 month, 3 months, 1 year
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The primary outcome measure will be the incidence of major adverse cardiac events (MACE) within one year post-procedure in patients undergoing left main coronary artery PCI.
MACE is defined as a composite of clinically significant endpoints including all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, and any revascularization procedures required after the initial PCI.
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up to 1 month, 3 months, 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ischemia-Driven Target Vessel Revascularization (ID-TVR) Ischemia-Driven Target Vessel Revascularization (ID-TVR)
Time Frame: 1 year
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Revascularization procedure that is performed on a previously treated vessel in patients who have developed ischemia.
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1 year
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Procedure-Related Complications Within 30 Days of PCI
Time Frame: 1 month
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This outcome will document the incidence of procedure-related complications, including bleeding, vascular complications, or acute kidney injury, occurring within 30 days post-PCI.
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1 month
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Health-Related Quality of Life (HRQoL) Scores One Year After PCI
Time Frame: 1 year
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Health-related quality of life using standardized questionnaire (SF-36) one year after the PCI procedure
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1 year
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Rate of stent thrombosis
Time Frame: 1 month, 3 months, 1 year
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Probable or definite stent thrombosis
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1 month, 3 months, 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2018
Primary Completion (Actual)
December 31, 2022
Study Completion (Actual)
December 31, 2023
Study Registration Dates
First Submitted
February 8, 2024
First Submitted That Met QC Criteria
February 15, 2024
First Posted (Actual)
February 16, 2024
Study Record Updates
Last Update Posted (Actual)
February 16, 2024
Last Update Submitted That Met QC Criteria
February 15, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PCI-LM-Registry-2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Planned after analysis
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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