Identification of Risk Factors for Acute Coronary Events by OCT After STEMI and NSTEMI in Patients With Residual Non-flow Limiting Lesions

NCT03857971 | Unknown

• 1 other identifier: NL67426.091.18
• Study Type: interventional
• Target: 438
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to compare the clinical outcome of Non-ST-elevation myocardial infarction (NSTEMI) and ST-elevation myocardial infarction (STEMI) patients with non-obstructive, non-culprit coronary lesions and either presence or absence of vulnerable plaque characteristics as assessed by optical coherence tomography (OCT).

Conditions

Myocardial Infarction; Acute Coronary Syndrome; Coronary Artery Disease

Keywords

Vulnerable plaque; Optical coherence Tomography; OCT

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiac Events

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

  2 years

Secondary Outcomes (3)

• Major Adverse Cardiac Events

  1 year

• Major Adverse Cardiac Events

  5 years

• Target lesion Failure

  2 and 5 years

Study Arms (1)

Coronary OCT imaging of non flow-limiting lesion

OTHER

Coronary OCT imaging will be performed of fractional flow reserve (FFR) negative lesions to assess plaque morphology.

Device: Coronary Optical Coherence tomography

Interventions

Coronary Optical Coherence tomography DEVICE

Optical coherence tomography imaging is performed of non-obstructive, non-culprit coronary lesions to assess plaque morphology.

Coronary OCT imaging of non flow-limiting lesion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent must be obtained.
• Patients with STEMI or NSTEMI and residual, non-culprit CAD, with the possibility of plaque vulnerability.
• Residual plaque(s) is(are) non-obstructive (FFR≥0.80).

You may not qualify if:

• Refusal or inability to provide informed consent.
• \< 18 years of age
• Hemodynamic instability, respiratory failure, Kilip class ≥ 3.
• Previous Coronary Artery Bypass Grafting (CABG).
• Indication for revascularization by CABG.
• Anatomy or lesions unsuitable for OCT catheter crossing or imaging (aorta-ostial lesions, small diameter segment, severe calcifications, lesion is too distal for OCT catheter)
• Pregnancy.
• Estimated life expectancy \< 3 year

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, South Holland, 6500HB, Netherlands

Location

Related Publications (3)

• Volleberg RHJA, Rroku A, Mol JQ, Hermanides RS, van Leeuwen M, Berta B, Meuwissen M, Alfonso F, Wojakowski W, Belkacemi A, Roleder T, Kedhi E, van Royen N; COMBINE (OCT-FFR) and PECTUS-obs investigators. FFR-Negative Nonculprit High-Risk Plaques and Clinical Outcomes in High-Risk Populations: An Individual Patient-Data Pooled Analysis From COMBINE (OCT-FFR) and PECTUS-obs. Circ Cardiovasc Interv. 2025 Feb;18(2):e014667. doi: 10.1161/CIRCINTERVENTIONS.124.014667. Epub 2025 Jan 22.

  PMID: 39840429 DERIVED

• Volleberg RHJA, Mol JQ, Belkacemi A, Hermanides RS, Meuwissen M, Protopopov AV, Laanmets P, Krestyaninov OV, Lacle CF, Oemrawsingh RM, van Kuijk JP, Arkenbout K, van der Heijden DJ, Rasoul S, Lipsic E, Rodwell L, Camaro C, Damman P, Roleder T, Kedhi E, van Leeuwen MAH, van Geuns RM, van Royen N. High-risk plaques in non-culprit lesions and clinical outcome after NSTEMI vs. STEMI. Eur Heart J Cardiovasc Imaging. 2025 Jan 31;26(2):197-206. doi: 10.1093/ehjci/jeae289.

  PMID: 39512201 DERIVED

• Mol JQ, Belkacemi A, Volleberg RH, Meuwissen M, Protopopov AV, Laanmets P, Krestyaninov OV, Dennert R, Oemrawsingh RM, van Kuijk JP, Arkenbout K, van der Heijden DJ, Rasoul S, Lipsic E, Teerenstra S, Camaro C, Damman P, van Leeuwen MA, van Geuns RJ, van Royen N. Identification of anatomic risk factors for acute coronary events by optical coherence tomography in patients with myocardial infarction and residual nonflow limiting lesions: rationale and design of the PECTUS-obs study. BMJ Open. 2021 Jul 7;11(7):e048994. doi: 10.1136/bmjopen-2021-048994.

  PMID: 34233996 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Acute Coronary Syndrome; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Niels van Royen, MD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: February 28, 2019
• Study Start: December 14, 2018
• Primary Completion: September 15, 2022
• Study Completion: June 14, 2025
• Last Updated: September 17, 2021

Record last verified: 2021-09

Locations

NL (1)