Coronary Artery DiseaseNCT06262971
Left Main Percutaneous Coronary Intervention Registry in Istanbul Medipol University Hospital
An observational study of Coronary Artery Disease and Left Main Coronary Artery Disease, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Left Main Coronary Artery Disease
- What is being tested?
- Percutaneous coronary intervention
- Type of treatment
- Medical device
- How many people
- 3,620 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2018to 31 Dec 2023
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: All patients performing any PCI procedure(s) in given timeframe will be included in this registry
Who may be able to join
- All patients undergoing any PCI procedure(s) in given timeframe will be included in this registry
Who cannot join
- Patients with no informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Percutaneous coronary intervention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary interventionDevice
balloon angioplasty, stent implantation, atherectomy, intravascular ultrasound.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Major Adverse Cardiac Events (MACE) within One Year Following Left Main Coronary Artery PCI
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.
Measured: up to 1 month, 3 months, 1 year
Secondary outcomes (4)
Ischemia-Driven Target Vessel Revascularization (ID-TVR) Ischemia-Driven Target Vessel Revascularization (ID-TVR)
Revascularization procedure that is performed on a previously treated vessel in patients who have developed ischemia.
Measured: 1 year
Procedure-Related Complications Within 30 Days of PCI
This outcome will document the incidence of procedure-related complications, including bleeding, vascular complications, or acute kidney injury, occurring within 30 days post-PCI.
Measured: 1 month
Health-Related Quality of Life (HRQoL) Scores One Year After PCI
Health-related quality of life using standardized questionnaire (SF-36) one year after the PCI procedure
Measured: 1 year
Rate of stent thrombosis
Probable or definite stent thrombosis
Measured: 1 month, 3 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start1 Jun 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2023
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 Medipol UniversityThe 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
- 3,620 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozgur Ulas Ozcan, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262971
- Sponsor's protocol ID
- PCI-LM-Registry-2018
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2024
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Planned after analysis
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Registry of Left Main Coronary Artery Percutaneous Coronary Intervention Outcomes at Istanbul Medipol University Hospital
- ClinicalTrials.gov ID
- NCT06262971
- Acronym / sponsor ID
- PCI-LM-Registry-2018
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,620 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 16 Feb 2024 (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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients performing any PCI procedure(s) in given timeframe will be included in this registry
Key inclusion criteria (1 listed)
- All patients undergoing any PCI procedure(s) in given timeframe will be included in this registry
Key exclusion criteria (1 listed)
- Patients with no informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous coronary interventionballoon angioplasty, stent implantation, atherectomy, intravascular ultrasound. | Device | – |
Primary outcome
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.
4 secondary outcomes
Ischemia-Driven Target Vessel Revascularization (ID-TVR) Ischemia-Driven Target Vessel Revascularization (ID-TVR)
Time frame: 1 year
Procedure-Related Complications Within 30 Days of PCI
Time frame: 1 month
Health-Related Quality of Life (HRQoL) Scores One Year After PCI
Time frame: 1 year
Rate of stent thrombosis
Time frame: 1 month, 3 months, 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Individual participant dataSharing planned: Undecided. Planned after analysis
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Left Main Coronary Artery Disease, run by Medipol University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 16 Feb 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 16 Feb 2024.