Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06506448
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-05-22
Brief Title:
Risk Characterization of Non-culprit Vessels in Patients Undergoing Primary PCI for ST-elevation MI in Multivessel Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Anatomical Physiological and Inflammatory Characterization of the Non-Culprit Vessels in Patients Undergoing Primary PCI for ST-Elevation Myocardial Infarction in the Presence of Multivessel Disease Toward a Personalised Approach to Complete Revascularisation After Primary PCI
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PICNIC
Brief Summary:
Most heart attacks occur because a clot forms in a coronary artery blocking blood flow Without blood heart muscle dies Untreated clots can cause a specific type of heart attack -ST-elevation myocardial infarction STEMI STEMI patients are treated immediately by finding the blocked artery culprit lesion using a dye injected into the coronary arteries and then by unblocking the artery using balloons and stents This procedure - primary angioplasty - is offered 247 and limits the size of heart attacks and saves lives
Cardiologists know how to treat STEMI patients but its less clear what to do about narrowings in other coronary arteries bystander disease This is important - if theyre left alone some bystander lesions can cause future events including heart attacks or angina Recent trials compared stenting ALL the bystander narrowings after primary angioplasty with stenting none and showed some benefit from stenting all of them complete revascularisation
However complete revascularisation carries extra risk putting patients through more complicated procedures and using up resource A blanket strategy of complete revascularisation of ALL bystander narrowings in ALL STEMI patients is unlikely to be the correct answer as only a small minority of these patients have further events
In PICNIC the investigators want to identify bystander narrowings most likely to cause a future event and those unlikely to do so The study can then test the hypothesis that only the high-risk bystander narrowings need stenting and the others can be treated with tablets only Investigators will study patients using specialised imaging techniques from coronary artery CT scans and levels of inflammation to see which narrowings cause future events and which do not If this can be done a case can be made to test complete revascularisation only in bystander narrowings that look high risk
Cardiologists know how to treat STEMI patients but its less clear what to do about narrowings in other coronary arteries bystander disease This is important - if theyre left alone some bystander lesions can cause future events including heart attacks or angina Recent trials compared stenting ALL the bystander narrowings after primary angioplasty with stenting none and showed some benefit from stenting all of them complete revascularisation
However complete revascularisation carries extra risk putting patients through more complicated procedures and using up resource A blanket strategy of complete revascularisation of ALL bystander narrowings in ALL STEMI patients is unlikely to be the correct answer as only a small minority of these patients have further events
In PICNIC the investigators want to identify bystander narrowings most likely to cause a future event and those unlikely to do so The study can then test the hypothesis that only the high-risk bystander narrowings need stenting and the others can be treated with tablets only Investigators will study patients using specialised imaging techniques from coronary artery CT scans and levels of inflammation to see which narrowings cause future events and which do not If this can be done a case can be made to test complete revascularisation only in bystander narrowings that look high risk
Detailed Description:
Approximately 50 of patients presenting with an acute ST-segment elevation myocardial infarction STEMI have multivessel coronary artery disease CAD Five randomized studies have shown that complete revascularization either at the time of primary percutaneous coronary intervention PPCI or within 45 days of the index admission is safe and reduces the risk of repeat coronary revascularization and myocardial infarction MI particularly in the non-infarct related artery NIRA Despite these improvements in clinical outcomes no study to date has provided a mechanistic insight as to how complete revascularization of chronic bystander disease may lead to the observed benefit Indeed the randomized studies through the variable nature of their results reduction in MI versus revascularization etc have suggested the possibility that there are differing mechanisms for the observed benefit The data would also be consistent with the concept that not all patients undergoing primary PCI with bystander disease require or benefit from complete revascularisation This is an important possibility with important potential implications for resource utilisation and patient experience
The investigators hypothesize that the susceptibility of non-culprit disease to ischaemic events after primary PCI is variable between individuals and possibly even between their coronary vessels and lesions Specifically the investigators postulate that this susceptibility may be related to multiple factors including their anatomical and physiological vulnerability and their local vascular inflammatory status In order to test this hypothesis the investigators will systematically examine the following parameters in each bystander coronary vessel in patients who present with STEMI and are undergoing primary PCI of the culprit vessel
1 markers of systemic inflammatory status
2 plaque anatomy including lesion severity and markers of lesion vulnerability on CTCA
3 assessment of individual coronary vessel inflammation using CT-derived fat attenuation index
4 vessel physiology using FFRCT fractional flow reserve from computed tomography incorporating wall shear stress and axial plaque stress
Aims
The aims of this study are to address the following research questions
1 What are the anatomical physiological inflammatory features of lesions in the NIRAs of patients presenting with STEMI who are treated with a strategy of culprit-only PPCI
2 Is there an association between these anatomical physiological inflammatory features and the risk of non-culprit lesions causing adverse events in STEMI patients with significant bystander disease in the NIRAs
The investigators hypothesize that the susceptibility of non-culprit disease to ischaemic events after primary PCI is variable between individuals and possibly even between their coronary vessels and lesions Specifically the investigators postulate that this susceptibility may be related to multiple factors including their anatomical and physiological vulnerability and their local vascular inflammatory status In order to test this hypothesis the investigators will systematically examine the following parameters in each bystander coronary vessel in patients who present with STEMI and are undergoing primary PCI of the culprit vessel
1 markers of systemic inflammatory status
2 plaque anatomy including lesion severity and markers of lesion vulnerability on CTCA
3 assessment of individual coronary vessel inflammation using CT-derived fat attenuation index
4 vessel physiology using FFRCT fractional flow reserve from computed tomography incorporating wall shear stress and axial plaque stress
Aims
The aims of this study are to address the following research questions
1 What are the anatomical physiological inflammatory features of lesions in the NIRAs of patients presenting with STEMI who are treated with a strategy of culprit-only PPCI
2 Is there an association between these anatomical physiological inflammatory features and the risk of non-culprit lesions causing adverse events in STEMI patients with significant bystander disease in the NIRAs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None