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

Conditions

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

  • Turkey
      • Istanbul, Turkey
        • Istanbul Medipol University

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
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.
up to 1 month, 3 months, 1 year

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
Revascularization procedure that is performed on a previously treated vessel in patients who have developed ischemia.
1 year
Procedure-Related Complications Within 30 Days of PCI
Time Frame: 1 month
This outcome will document the incidence of procedure-related complications, including bleeding, vascular complications, or acute kidney injury, occurring within 30 days post-PCI.
1 month
Health-Related Quality of Life (HRQoL) Scores One Year After PCI
Time Frame: 1 year
Health-related quality of life using standardized questionnaire (SF-36) one year after the PCI procedure
1 year
Rate of stent thrombosis
Time Frame: 1 month, 3 months, 1 year
Probable or definite stent thrombosis
1 month, 3 months, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medipol University

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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