LCx Occlusion STEMINCT06750328
Outcomes of Isolated LCx Occlusion
An observational study of LCx Occlusion STEMI and STEMI, run by Assiut University.
Trial summary
To assess procedural success and short term clinical outcomes of primary PCI to isolated LCx acute occlusion. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- LCx Occlusion STEMI, STEMI
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 16 Dec 2024to 12 Nov 2027
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Baseline demographic, angiographic and clinical data, including cardiovascular risk factors, will be retrospectively collected. For follow up, we will contact every patient included in our study to ask about MACE.
Who may be able to join
- Patients presented to Assiut University heart hospital with STEMI who underwent primary PCI that revealed isolated LCx acute occlusion (single culprit artery) between January 2018 to January 2025 will be included.
Who cannot join
- -Patients with cardiogenic shock, NYHA class III-IV and multivessel coronary artery disease will be excluded.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Esraa Gamal Mohammed, Master student contact
About this study
Official title: Procedural and Clinical Outcomes of Isolated Left Circumflex Coronary Artery Acute Occlusion in Patients Undergoing Primary Percutaneous Coronary Intervention
To assess procedural success and short term clinical outcomes of primary PCI to isolated LCx acute occlusion.
Read the detailed description
ST-segment elevation myocardial infarction (STEMI) involving acute occlusion of the left circumflex (LCx) coronary artery represent only 14-21% of STEMIs
LCx acute occlusion may be difficult to be diagnosed . Only 50% of patients with LCx occlusion exhibited ST segment elevation during the acute phase, 38% showed no ST segment changes, while 15% presented with isolated ST segment depression This may lead to delay in transfer to cath lab, delay in reperfusion therapy and consequently loss of more myocytes and more major adverse cardiovascular events (MACE) .
Due to relative rare occurrence of isolated LCx coronary artery occlusion, little is known in literature about the clinical outcomes of isolated LCx occlusion , so we will conduct a retrospective observational study in our tertiary primary percutaneous coronary intervention (PCI) center to detect the incidence , procedural and clinical outcomes after 6 months of patients who had isolated LCx acute occlusion and underwent primary PCI.
- Conditions
- LCx Occlusion STEMI, STEMI
- Keywords
- LCx occlusion STEMI
- Medical subject headings
- ST Elevation Myocardial Infarction
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 |
|---|---|---|
| Follow up after PPCI | To assess procedural success and short term clinical outcomes of primary PCI to isolated LCx acute |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications of PPCI to LCx occlusion
defined as angiographic success without in-hospital complications). Angiographic success (defined as in-stent residual stenosis ≤30% without serious angiographic complications (severe coronary dissection impairing flow [type D-F], perforation, abrupt closure or no reflow) .
Measured: 6 months
Secondary outcomes (1)
Long follow up of outcomes of PPCI of LCx outcomes
The secondary endpoint will be assessment of MACE at 6 months following the index procedure. MACE ( defined as the composite of all-cause mortality, target lesion revascularization, stent thrombosis, documented atrial fibrillation and development of heart failure).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start16 Dec 2024 (estimated)
- Primary completion12 Dec 2025 (estimated)
- Study completion12 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for LCx Occlusion STEMIStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa gamal mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750328
- Sponsor's protocol ID
- LCx occlusion
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Geffin R, Triska J, Najjar S, Berman J, Cruse M, Birnbaum Y. Why do we keep missing left circumflex artery myocardial infarctions? J Electrocardiol. 2024 Mar-Apr;83:4-11. doi: 10.1016/j.jelectrocard.2023.12.011. Epub 2023 Dec 26.
PubMed 38181483From AM, Best PJ, Lennon RJ, Rihal CS, Prasad A. Acute myocardial infarction due to left circumflex artery occlusion and significance of ST-segment elevation. Am J Cardiol. 2010 Oct 15;106(8):1081-5. doi: 10.1016/j.amjcard.2010.06.016.
PubMed 20920642Stribling WK, Kontos MC, Abbate A, Cooke R, Vetrovec GW, Dai D, Honeycutt E, Wang TY, Lotun K. Left circumflex occlusion in acute myocardial infarction (from the National Cardiovascular Data Registry). Am J Cardiol. 2011 Oct 1;108(7):959-63. doi: 10.1016/j.amjcard.2011.05.027. Epub 2011 Aug 4.
PubMed 21820644
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procedural and Clinical Outcomes of Isolated Left Circumflex Coronary Artery Acute Occlusion in Patients Undergoing Primary Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT06750328
- Acronym / sponsor ID
- LCx occlusion
- Conditions
- LCx Occlusion STEMI, STEMI
- Keywords
- LCx occlusion STEMI
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 16 Dec 2024 (estimated)
- Primary completion
- 12 Dec 2025 (estimated)
- Study completion
- 12 Nov 2027 (estimated)
- First posted
- 27 Dec 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.
To assess procedural success and short term clinical outcomes of primary PCI to isolated LCx acute occlusion.
Detailed description
ST-segment elevation myocardial infarction (STEMI) involving acute occlusion of the left circumflex (LCx) coronary artery represent only 14-21% of STEMIs
LCx acute occlusion may be difficult to be diagnosed . Only 50% of patients with LCx occlusion exhibited ST segment elevation during the acute phase, 38% showed no ST segment changes, while 15% presented with isolated ST segment depression This may lead to delay in transfer to cath lab, delay in reperfusion therapy and consequently loss of more myocytes and more major adverse cardiovascular events (MACE) .
Due to relative rare occurrence of isolated LCx coronary artery occlusion, little is known in literature about the clinical outcomes of isolated LCx occlusion , so we will conduct a retrospective observational study in our tertiary primary percutaneous coronary intervention (PCI) center to detect the incidence , procedural and clinical outcomes after 6 months of patients who had isolated LCx acute occlusion and underwent primary PCI.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Follow up after PPCI | – | –To assess procedural success and short term clinical outcomes of primary PCI to isolated LCx acute |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Baseline demographic, angiographic and clinical data, including cardiovascular risk factors, will be retrospectively collected. For follow up, we will contact every patient included in our study to ask about MACE.
Key inclusion criteria (1 listed)
- Patients presented to Assiut University heart hospital with STEMI who underwent primary PCI that revealed isolated LCx acute occlusion (single culprit artery) between January 2018 to January 2025 will be included.
Key exclusion criteria (1 listed)
- -Patients with cardiogenic shock, NYHA class III-IV and multivessel coronary artery disease will be excluded.
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
Complications of PPCI to LCx occlusion
Time frame: 6 months
defined as angiographic success without in-hospital complications). Angiographic success (defined as in-stent residual stenosis ≤30% without serious angiographic complications (severe coronary dissection impairing flow [type D-F], perforation, abrupt closure or no reflow) .
1 secondary outcome
Long follow up of outcomes of PPCI of LCx outcomes
Time frame: 6 months
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 27 Dec 2024.
- Background: PubMed 38181483Geffin R, Triska J, Najjar S, Berman J, Cruse M, Birnbaum Y. Why do we keep missing left circumflex artery myocardial infarctions? J Electrocardiol. 2024 Mar-Apr;83:4-11. doi: 10.1016/j.jelectrocard.2023.12.011. Epub 2023 Dec 26.
- Background: PubMed 20920642From AM, Best PJ, Lennon RJ, Rihal CS, Prasad A. Acute myocardial infarction due to left circumflex artery occlusion and significance of ST-segment elevation. Am J Cardiol. 2010 Oct 15;106(8):1081-5. doi: 10.1016/j.amjcard.2010.06.016.
- Background: PubMed 21820644Stribling WK, Kontos MC, Abbate A, Cooke R, Vetrovec GW, Dai D, Honeycutt E, Wang TY, Lotun K. Left circumflex occlusion in acute myocardial infarction (from the National Cardiovascular Data Registry). Am J Cardiol. 2011 Oct 1;108(7):959-63. doi: 10.1016/j.amjcard.2011.05.027. Epub 2011 Aug 4.
- Individual participant dataSharing planned: No
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.
Esraa Gamal Mohammed, Master student contact
Questions about this trial
What is this clinical trial studying?
An observational study of LCx Occlusion STEMI and STEMI, run by Assiut University.
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: opening soon, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Esraa Gamal Mohammed, Master student (+2 01158863129 ext. +2 01063021526, alaajamal851@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications of PPCI to LCx occlusion (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06750328, which also lists 3 linked publications.
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 27 Dec 2024.