Back to resultsIdentification of Risk Factors for Acute Coronary Events by OCT After STEMI and NSTEMI in Patients With Residual Non-flow Limiting Lesions (PECTUS-obs)
Primary Purpose
Myocardial Infarction, Acute Coronary Syndrome, Coronary Artery Disease
Status
Active
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Coronary Optical Coherence tomography
Sponsored by
About this trial
This is an interventional diagnostic trial for Myocardial Infarction focused on measuring Vulnerable plaque, Optical coherence Tomography, OCT
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
Sites / Locations
- Radboudumc
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Coronary OCT imaging of non flow-limiting lesion
Arm Description
Coronary OCT imaging will be performed of fractional flow reserve (FFR) negative lesions to assess plaque morphology.
Outcomes
Primary Outcome Measures
Major Adverse Cardiac Events
Composite of all cause mortality, non-fatal myocardial infarction or unplanned revascularization.
Secondary Outcome Measures
Major Adverse Cardiac Events
Composite of all cause mortality, non-fatal myocardial infarction or unplanned revascularization.
Major Adverse Cardiac Events
Composite of all cause mortality, non-fatal myocardial infarction or unplanned revascularization.
Target lesion Failure
Cardiac death caused by target lesion, myocardial infarction caused by target lesion, revascularisation of target lesion
Full Information
NCT ID
NCT03857971
First Posted
February 27, 2019
Last Updated
September 16, 2021
Sponsor
Radboud University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03857971
Brief Title
Identification of Risk Factors for Acute Coronary Events by OCT After STEMI and NSTEMI in Patients With Residual Non-flow Limiting Lesions
Acronym
PECTUS-obs
Official Title
Identification of Risk Factors for Acute Coronary Events by Optical Coherence Tomography After STEMI and NSTEMI in Patients With Residual Non-flow Limiting Lesions The 'PECTUS-obs' Trial (Observational Cohort)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 14, 2018 (Actual)
Primary Completion Date
September 15, 2022 (Anticipated)
Study Completion Date
June 14, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
Detailed Description
Despite major advances in the treatment of acute coronary syndromes a large proportion of patients is still at risk for new coronary events after experiencing an acute coronary syndrome (ACS). Detection of residual vulnerable plaques after ACS using OCT potentially identifies patients at high risk for new coronary events. However, no prospectively collected data on the prognostic power of OCT for plaque rupture are available at this moment. To design trials aimed to reduce events in patients with vulnerable plaques it is required to collect such prospective data on the relation between OCT derived characteristics of vulnerability and clinical outcome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Acute Coronary Syndrome, Coronary Artery Disease
Keywords
Vulnerable plaque, Optical coherence Tomography, OCT
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
438 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Coronary OCT imaging of non flow-limiting lesion
Arm Type
Other
Arm Description
Coronary OCT imaging will be performed of fractional flow reserve (FFR) negative lesions to assess plaque morphology.
Intervention Type
Device
Intervention Name(s)
Coronary Optical Coherence tomography
Intervention Description
Optical coherence tomography imaging is performed of non-obstructive, non-culprit coronary lesions to assess plaque morphology.
Primary Outcome Measure Information:
Title
Major Adverse Cardiac Events
Description
Composite of all cause mortality, non-fatal myocardial infarction or unplanned revascularization.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Major Adverse Cardiac Events
Description
Composite of all cause mortality, non-fatal myocardial infarction or unplanned revascularization.
Time Frame
1 year
Title
Major Adverse Cardiac Events
Description
Composite of all cause mortality, non-fatal myocardial infarction or unplanned revascularization.
Time Frame
5 years
Title
Target lesion Failure
Description
Cardiac death caused by target lesion, myocardial infarction caused by target lesion, revascularisation of target lesion
Time Frame
2 and 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niels van Royen, MD, PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboudumc
City
Nijmegen
State/Province
Zuid-Holland
ZIP/Postal Code
6500HB
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34233996
Citation
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.
Results Reference
derived
Learn more about this trial
Identification of Risk Factors for Acute Coronary Events by OCT After STEMI and NSTEMI in Patients With Residual Non-flow Limiting Lesions
We'll reach out to this number within 24 hrs