OCT Guided vs COmplete Pci in patieNts With sT Segment Elevation myocArdial infarCtion and mulTivessel Disease (OCT-CONTACT)
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|ClinicalTrials.gov Identifier: NCT04878133|
Recruitment Status : Recruiting
First Posted : May 7, 2021
Last Update Posted : May 11, 2021
|Condition or disease||Intervention/treatment||Phase|
|Acute Coronary Syndrome||Diagnostic Test: OCT - optical coherence tomography||Not Applicable|
In patients with ST segment elevation myocardial infarction (STEMI), percutaneous coronary intervention (PCI) of the culprit lesion significally reduces the risk of cardiovascular death. How to manage in this setting non-culprit lesion in patients with multivessel disease still remain a matter of debate. Recently, the COMPLETE trial showed that complete PCI of every coronary stenosis > 70% (or 50-69% lesions with FFR < 0.8) reduces risk of myocardial infarction (MI) and unstable angina (UA) at 3 years compared with culprit-lesion PCI . Whether this findings are related to revascularization of every obstructive lesions rather than lesions with vulnerable-plaque characteristics, still remain unclear.
In high risk patients such as STEMI patients, physiopathology of coronary plaque deeply differs from stable angina, mainly due to peculiar features of plaque. STEMI lesions, when evaluated at autopsy or at intracoronary imaging, showed a pro-thrombotic pattern, with high prevalence of thin cap fibro-atheroma, plaque rupture or thrombus, and a larger amount of lipids and macrophage [2-6]. In this setting, angiography, even when combined with fractional flow reserve evaluation (which can describe more accurately the functional impact of the plaque), has intrinsic limitations because of lack of information about plaque characteristics [7,8].
Optical coherence tomography (OCT) is the latest development in intravascular coronary imaging. Similarly to intravascular ultrasound (IVUS), OCT provides cross-sectional images of the vessel. However, instead of sound, OCT employs light for tissue analysis that enables visualization of the coronary lesions with almost microscopic precision [9,10].
This tool can find high risk vulnerable plaque without angiographic or functional signs of severity, helping from misdiagnosing and under-treating these lesions, that could benefit from PCI even more than obstructive lesions without vulnerable plaque characteristics.
In an OCT substudy of the COMPLETE trial, researchers determined that half of patients had obstructive nonculprit lesions with vulnerable plaque, which could explain why complete revascularization conferred better outcomes than culprit lesion-only revascularization in the main trial. This substudy pointed out also a 20% of non-obstructive non-culprit lesions with vulnerable plaque caracteristics and up to 30% of obstructive non-culprit lesions without high risk morphology . It suggest that a morphological approach to PCI in high risk patients can provide a more specific treatment compared with standard angiographic/functional approach. A correct identification of coronary plaque instability in a setting of STEMI patients could deeply impact in these patients risk of cardiovascular events, angina and re- hospitalization.
Being coronary artery disease a pandemic disease with an important impact on nations health care, a reduction in events in these patients do not impact only on patients quality of life, but on health care system resources.
Consequently, we propose a randomized controlled trial to evaluate the effective benefit of OCT guided vs complete PCI in STEMI patients with multivessels coronary artery disease.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||460 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Patients with STEMI who underwent successful culprit-lesion PCI will be enrolled after the index PCI. Eligible patients will be required to have residual multivessel disease, defined as at least one stenosis >
50 %. Patients will be randomized in a 1:1 fashion to OCT guided PCI of non-culprit lesions (Group A) vs complete PCI. (Group B)
|Masking:||None (Open Label)|
|Official Title:||OCT Guided vs COmplete Pci in patieNts With sT Segment Elevation myocArdial infarCtion and mulTivessel Disease|
|Actual Study Start Date :||February 1, 2021|
|Estimated Primary Completion Date :||January 31, 2023|
|Estimated Study Completion Date :||January 31, 2025|
|Experimental: Exsperimental Arm||
Diagnostic Test: OCT - optical coherence tomography
The principle by which OCT works is similar to ultrasound, although light waves close to infrared are used instead of ultrasounds.
In practice, the light waves, emitted into the vessel through a special catheter positioned in the coronary artery, meet the surrounding structures and are partly absorbed and partly reflected by them. The reflected waves are picked up by a sensor positioned on the catheter and analyzed through software that produces images visible live on a special console.
|No Intervention: Control Arm|
- Major adverse cardiovascular events (MACE) [ Time Frame: 24 mounth after the recruitment in the study ]Composite endopoint of all cause mortality, cardiovascular mortality, non-fatal myocardial infarction, unplanned revascularization.
- Secondary efficacy end-points [ Time Frame: 24 mounth after the recruitment in the study ]Rate of all cause mortality, cardiovascular mortality, non-fatal myocardial infarction, unplanned revascularization taking separately.
- Safety end-points [ Time Frame: 24 mounth after the recruitment in the study ]Rate of Acute kidney injury (AKI) following OCT vs complete guided PCI, defined according to the Acute Kidney Injury Network criteria
- Safety end-points [ Time Frame: 24 mounth after the recruitment in the study ]Rate of procedural complications following each PCI: periprocedural MI defined according to the Fourth Universal Definition of Myocardial Infarction , arterial access site complications, AKI
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04878133
|Città della Salute e della Scienza di Torino||Recruiting|
|Torino, Piemonte, Italy, 10100|
|Contact: Fabrizio D'Ascenzo, MD +390116335570 firstname.lastname@example.org|
|Principal Investigator: Fabrizio D'Ascenzo, MD|
|Sub-Investigator: Mattia Peyracchia, MD|
|Ospedale San Luigi Gonzaga, Orbassano||Recruiting|
|Orbassano, Italy, 10043|
|Contact: Enrico Cerrato 347 9317104 email@example.com|
|Ospedale di Rivoli||Recruiting|
|Rivoli, Italy, 10098|
|Contact: Giorgio Quadri + 393487936963 firstname.lastname@example.org|
|AOU Città della Salute e della Scienza di Torino||Recruiting|
|Torino, Italy, 10126|
|Contact: Fabrizio D'Ascenzo, MD +390116336023 email@example.com|
|Ospedale San Giovanni Bosco||Recruiting|
|Torino, Italy, 10144|
|Contact: Mario Iannacone +393391812226 firstname.lastname@example.org|
|Citta della Salute||Recruiting|
|Turin, Italy, 10128|
|Contact: Fabrizio D'Ascenzo, MD 0116336023 email@example.com|
|Principal Investigator: Fabrizio D'Ascenzo, MD|