Myocardial InfarctionPECTUS-obsNCT03857971
Identification of Risk Factors for Acute Coronary Events by OCT After STEMI and NSTEMI in Patients With Residual Non-flow Limiting Lesions
A study testing Coronary Optical Coherence tomography in people with Myocardial Infarction and Acute Coronary Syndrome, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Acute Coronary Syndrome, Coronary Artery Disease
- What is being tested?
- Coronary Optical Coherence tomography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 438 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 Dec 2018to 14 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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).
Read the 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.
- Being tested
- Coronary Optical Coherence tomography
- Keywords
- Vulnerable plaque, Optical coherence Tomography, OCT
- Medical subject headings
- Myocardial Infarction, Acute Coronary Syndrome, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Optical Coherence tomographyDevice
Optical coherence tomography imaging is performed of non-obstructive, non-culprit coronary lesions to assess plaque morphology.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Coronary Optical Coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac Events
Composite of all cause mortality, non-fatal myocardial infarction or unplanned revascularization.
Measured: 2 years
Secondary outcomes (3)
Major Adverse Cardiac Events
Composite of all cause mortality, non-fatal myocardial infarction or unplanned revascularization.
Measured: 1 year
Major Adverse Cardiac Events
Composite of all cause mortality, non-fatal myocardial infarction or unplanned revascularization.
Measured: 5 years
Target lesion Failure
Cardiac death caused by target lesion, myocardial infarction caused by target lesion, revascularisation of target lesion
Measured: 2 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start14 Dec 2018
- Primary completion15 Sep 2022 (estimated)
- Study completion14 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 438 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Niels van Royen, MD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857971
- Sponsor's protocol ID
- NL67426.091.18
- Acronym
- PECTUS-obs
- Status last verified
- Sep 2021
- First submitted
- 27 Feb 2019
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Volleberg RHJA, Mol JQ, Versteeg GAA, van der Zande J, 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, Camaro C, Damman P, Roleder T, Kedhi E, van Leeuwen MAH, van Geuns RM, van Royen N. Long-Term Clinical Outcomes of High-Risk Plaques with Negative fractional flow reserve: the PECTUS-obs study. EuroIntervention. 2026 May 21;22(16):864-73. doi: 10.4244/EIJ-D-26-00416. Online ahead of print.
PubMed 42200638Volleberg 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.
PubMed 39840429Volleberg 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.
PubMed 39512201Mol 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.
PubMed 34233996
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03857971
- Acronym / sponsor ID
- PECTUS-obs / NL67426.091.18
- Keywords
- Vulnerable plaque, Optical coherence Tomography, OCT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 438 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 14 Dec 2018 (actual)
- Primary completion
- 15 Sep 2022 (estimated)
- Study completion
- 14 Jun 2025 (estimated)
- First posted
- 28 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary OCT imaging of non flow-limiting lesion | Other | Device: Coronary Optical Coherence tomographyCoronary OCT imaging will be performed of fractional flow reserve (FFR) negative lesions to assess plaque morphology. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary Optical Coherence tomographyOptical coherence tomography imaging is performed of non-obstructive, non-culprit coronary lesions to assess plaque morphology. | Device | Coronary OCT imaging of non flow-limiting lesion |
Primary outcome
Major Adverse Cardiac Events
Time frame: 2 years
Composite of all cause mortality, non-fatal myocardial infarction or unplanned revascularization.
3 secondary outcomes
Major Adverse Cardiac Events
Time frame: 1 year
Major Adverse Cardiac Events
Time frame: 5 years
Target lesion Failure
Time frame: 2 and 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
- Derived from this study: PubMed 42200638Volleberg RHJA, Mol JQ, Versteeg GAA, van der Zande J, 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, Camaro C, Damman P, Roleder T, Kedhi E, van Leeuwen MAH, van Geuns RM, van Royen N. Long-Term Clinical Outcomes of High-Risk Plaques with Negative fractional flow reserve: the PECTUS-obs study. EuroIntervention. 2026 May 21;22(16):864-73. doi: 10.4244/EIJ-D-26-00416. Online ahead of print.
- Derived from this study: PubMed 39840429Volleberg 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.
- Derived from this study: PubMed 39512201Volleberg 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.
- Derived from this study: PubMed 34233996Mol 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niels van Royen, MD, PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary Optical Coherence tomography in people with Myocardial Infarction and Acute Coronary Syndrome, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiac Events (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03857971, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2021.