Ignite Creation Date:
2024-05-06 @ 10:15 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03205514
Status:
COMPLETED
Last Update Posted:
2021-04-29
First Post:
2017-06-28
Brief Title:
Multimodality Investigation of Intermediate Culprit Lesion With Negative FFR in NSTE-ACS
Sponsor:
University Hospital of Ferrara
Organization:
University Hospital of Ferrara
Study Overview
Official Title:
Multimodality Investigation of Intermediate Culprit Lesion With Negative Fractional Flow Reserve in Patients With no ST-segment Elevation Acute Coronary Syndrome
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SHERLOCK
Brief Summary:
Ten-fifteen percent of acute coronary syndromes without ST-segment elevation NSTE-ACS are caused by intermediate lesions without signs of unstable plaque In this subset of patients fractional flow reserve FFR has some drawbacks and may not be always able to predict outcome especially when negative above 080 In this particular nique of patients advanced imaging techniques are suggested by International guidelines However it is actually unknown how these techniques may impact treatment strategies With the present study the investigators want to characterize the mechanism of disease in this particular subset of patients through multimodality imaging intravascular ultrasound-near infrared spectroscopy IVUS-NIRS optical coherence tomography OCT in order to understand the proper treatment
Detailed Description:
Acute coronary syndrome without ST-segment elevation NSTE-ACS is by far the most frequent acute coronary syndrome ACS in the western world In most of the cases it is caused by a clearly identifiable culprit lesion configuring a significant angiographic stenosis 70 with flux limitation and typical aspects of unstable plaque thrombosis In these cases the one and only treatment is stent implantation In a small percentage of patients 10-15 NSTE-ACS is caused by an angiographically intermediate lesion 40-70 This lesion is identifiable as culprit but without the typical signs of unstable plaque
In patients with stable coronary artery disease SCAD presenting with this type of lesion fractional flow reserve FFR is the actual gold-standard for ischemic burden evaluation Several studies showed that if FFR value is 080 the treatment with percutaneous coronary intervention PCI is associated with a significant reduction of hard cardiovascular events When FFR is negative 080 optical medical therapy showed a better outcome when compared to percutaneous intervention In NSTE-ACS FFR evaluation of intermediate lesions is still mandatory as a recent study showed a better outcome in patient with positive fractional flow reserve treated invasively with stenting compared to patients treated solely based on angiography 1 When FFR is negative several authors and studies suggest that further imaging techniques are needed In this subgroup of patients with intermediate stenosis without angiographic evidence of plaque rupture European Guidelines 2 suggest utilization of intravascular ultrasound-near infrared spectroscopy IVUS-NIRS or optical coherence tomography OCT in order to better characterize the culprit plaque At the same time the therapeutic strategy is left to the operators discretion some implant a stent in order to reduce occurrence of future events while some others leave the patient in optical medical therapy without stent implantation Moreover in these patients it is still unclear the pathophysiology of the disease leading to ACS In the last years researchers focused their attention on plaque erosion deemed to be responsible for most of these NSTE-ACS 3 An imaging study evaluated the incidence of plaque erosion in patients with ACS 4 This study enrolled an heterogeneous group of patients evaluated with a single imaging technique OCT
Based on these background the investigators hypothesized to perform a prospective single-center data registry on this highly selected subgroup of patients NSTE-ACS with culprit intermediate lesion with negative FFR evaluation
Investigators will enroll consecutive patients with NSTE-ACS with a culprit intermediate stenosis between 40 and 70 and in whom FFR evaluation will result negative 080 In these patients the operator will perform IVUS-NIRS and OCT and a blood sample to evaluate endothelial function as per our previous experience 5 The study has no control group Endothelial function and inflammatory state will be evaluated in all patients and will be compared to those obtained by patients enrolled in the NATHAN NEVER study NCT02519608 Study ID 1504975
Aim of the present study is to understand whether in this group of patient endothelial function is impaired and which information is given by intracoronary imaging presence of plaque erosion The present study is a prospective data collection Thus a formal sample size calculation is not applicable Contemporaneously for pilot studies at least 30 patients are recommended 6
In patients with stable coronary artery disease SCAD presenting with this type of lesion fractional flow reserve FFR is the actual gold-standard for ischemic burden evaluation Several studies showed that if FFR value is 080 the treatment with percutaneous coronary intervention PCI is associated with a significant reduction of hard cardiovascular events When FFR is negative 080 optical medical therapy showed a better outcome when compared to percutaneous intervention In NSTE-ACS FFR evaluation of intermediate lesions is still mandatory as a recent study showed a better outcome in patient with positive fractional flow reserve treated invasively with stenting compared to patients treated solely based on angiography 1 When FFR is negative several authors and studies suggest that further imaging techniques are needed In this subgroup of patients with intermediate stenosis without angiographic evidence of plaque rupture European Guidelines 2 suggest utilization of intravascular ultrasound-near infrared spectroscopy IVUS-NIRS or optical coherence tomography OCT in order to better characterize the culprit plaque At the same time the therapeutic strategy is left to the operators discretion some implant a stent in order to reduce occurrence of future events while some others leave the patient in optical medical therapy without stent implantation Moreover in these patients it is still unclear the pathophysiology of the disease leading to ACS In the last years researchers focused their attention on plaque erosion deemed to be responsible for most of these NSTE-ACS 3 An imaging study evaluated the incidence of plaque erosion in patients with ACS 4 This study enrolled an heterogeneous group of patients evaluated with a single imaging technique OCT
Based on these background the investigators hypothesized to perform a prospective single-center data registry on this highly selected subgroup of patients NSTE-ACS with culprit intermediate lesion with negative FFR evaluation
Investigators will enroll consecutive patients with NSTE-ACS with a culprit intermediate stenosis between 40 and 70 and in whom FFR evaluation will result negative 080 In these patients the operator will perform IVUS-NIRS and OCT and a blood sample to evaluate endothelial function as per our previous experience 5 The study has no control group Endothelial function and inflammatory state will be evaluated in all patients and will be compared to those obtained by patients enrolled in the NATHAN NEVER study NCT02519608 Study ID 1504975
Aim of the present study is to understand whether in this group of patient endothelial function is impaired and which information is given by intracoronary imaging presence of plaque erosion The present study is a prospective data collection Thus a formal sample size calculation is not applicable Contemporaneously for pilot studies at least 30 patients are recommended 6
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None