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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
Sponsor:
Information provided by (Responsible Party):
Fabrizio D'Ascenzo, Azienda Ospedaliera Città della Salute e della Scienza di Torino

Brief Summary:
STEMI patients with multivessel disease will be randomized to complete PCI versus PCI driven by high risk criteria of plaques evaluated with OCT

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Diagnostic Test: OCT - optical coherence tomography Not Applicable

Detailed Description:

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 [1]. 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 [11]. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 460 participants
Allocation: Randomized
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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

  2. 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 [15], arterial access site complications, AKI



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients with STEMI and residual non culprit CAD
  2. Informed consent

Exclusion Criteria:

  1. Refusal or inability to provide informed consent.
  2. < 18 years of age
  3. Cardiogenic shock
  4. Previous Coronary Artery Bypass Grafting (CABG
  5. Indication for revascularization by CABG.
  6. eGFR < 30 ml/min/m2
  7. ULM stenosis
  8. Estimated life expectancy < 3 year
  9. Non culprit CTO lesion

Information from the National Library of Medicine

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


Locations
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Italy
Città della Salute e della Scienza di Torino Recruiting
Torino, Piemonte, Italy, 10100
Contact: Fabrizio D'Ascenzo, MD    +390116335570    fabrizio.dascenzo@gmail.com   
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    enrico.cerrato@gmail.com   
Ospedale di Rivoli Recruiting
Rivoli, Italy, 10098
Contact: Giorgio Quadri    + 393487936963    lo.savio.luca88@gmail.com   
AOU Città della Salute e della Scienza di Torino Recruiting
Torino, Italy, 10126
Contact: Fabrizio D'Ascenzo, MD    +390116336023    fabrizio.dascenzo@gmail.com   
Ospedale San Giovanni Bosco Recruiting
Torino, Italy, 10144
Contact: Mario Iannacone    +393391812226    mario.iannaccone@hotmail.it   
Citta della Salute Recruiting
Turin, Italy, 10128
Contact: Fabrizio D'Ascenzo, MD    0116336023    fabrizio.dascenzo@gmail.com   
Principal Investigator: Fabrizio D'Ascenzo, MD         
Sponsors and Collaborators
Azienda Ospedaliera Città della Salute e della Scienza di Torino
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Responsible Party: Fabrizio D'Ascenzo, Cardiologist, Azienda Ospedaliera Città della Salute e della Scienza di Torino
ClinicalTrials.gov Identifier: NCT04878133    
Other Study ID Numbers: OCT - 001621
First Posted: May 7, 2021    Key Record Dates
Last Update Posted: May 11, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
Acute Coronary Syndrome
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases