OCT Guided vs COmplete Pci in patieNts With sT Segment Elevation myocArdial infarCtion and mulTivessel Disease

NCT04878133 | Unknown DMC

• 1 other identifier: OCT - 001621
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 6

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

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiovascular events (MACE)

  Composite endopoint of all cause mortality, cardiovascular mortality, non-fatal myocardial infarction, unplanned revascularization.

  24 mounth after the recruitment in the study

Secondary Outcomes (1)

• Secondary efficacy end-points

  24 mounth after the recruitment in the study

Other Outcomes (2)

• Safety end-points

  24 mounth after the recruitment in the study

• Safety end-points

  24 mounth after the recruitment in the study

Study Arms (2)

Exsperimental Arm

EXPERIMENTAL

Diagnostic Test: OCT - optical coherence tomography

Control Arm

NO INTERVENTION

Interventions

OCT - optical coherence tomography DIAGNOSTIC_TEST

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.

Exsperimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with STEMI and residual non culprit CAD
• Informed consent

You may not qualify if:

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

Sponsors & Collaborators

• A.O.U. Città della Salute e della Scienza: lead

Study Sites (6)

Città della Salute e della Scienza di Torino

Turin, Piedmont, 10100, Italy

RECRUITING

Ospedale San Luigi Gonzaga, Orbassano

Orbassano, 10043, Italy

RECRUITING

Ospedale di Rivoli

Rivoli, 10098, Italy

RECRUITING

AOU Città della Salute e della Scienza di Torino

Torino, 10126, Italy

RECRUITING

Ospedale San Giovanni Bosco

Torino, 10144, Italy

RECRUITING

Citta della Salute

Turin, 10128, Italy

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist

Model Details: 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)

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 7, 2021
• Study Start: February 1, 2021
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2025
• Last Updated: May 11, 2021

Record last verified: 2021-05

Locations

IT (6)