Acute Coronary SyndromeOCT-CONTACTNCT04878133
OCT Guided vs COmplete Pci in patieNts With sT Segment Elevation myocArdial infarCtion and mulTivessel Disease
A study testing OCT - optical coherence tomography in people with Acute Coronary Syndrome, run by A.O.U. Città della Salute e della Scienza at 6 sites in Italy.
Trial summary
STEMI patients with multivessel disease will be randomized to complete PCI versus PCI driven by high risk criteria of plaques evaluated with OCT Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- OCT - optical coherence tomography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 6 sitesItaly
- Study dates
- 1 Feb 2021to 26 Sep 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with STEMI and residual non culprit CAD
- Informed consent
Who cannot join
- 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
Show all 9Show fewer
- ULM stenosis
- Estimated life expectancy < 3 year
- Non culprit CTO lesion
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites
Ospedale San Luigi Gonzaga, Orbassano
Orbassano, 10043
Ospedale di Rivoli
Rivoli, Italy, 10098
AOU Città della Salute e della Scienza di Torino
Torino, Italy, 10126
Ospedale San Giovanni Bosco
Torino, Italy, 10144
Città della Salute e della Scienza di Torino
Turin, Piedmont, 10100
Citta della Salute
Turin, Turin, 10128
About this study
STEMI patients with multivessel disease will be randomized to complete PCI versus PCI driven by high risk criteria of plaques evaluated with OCT
Read the 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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- OCT - optical coherence tomography
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT - optical coherence tomographyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Exsperimental Arm | Experimental | Not described Receives: Diagnostic Test: OCT - optical coherence tomography |
| Control Arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events (MACE)
Composite endopoint of all cause mortality, cardiovascular mortality, non-fatal myocardial infarction, unplanned revascularization.
Measured: 24 mounth after the recruitment in the study
Secondary outcomes (1)
Secondary efficacy end-points
Rate of all cause mortality, cardiovascular mortality, non-fatal myocardial infarction, unplanned revascularization taking separately.
Measured: 24 mounth after the recruitment in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start1 Feb 2021
- Primary completion31 Jan 2025
- Study completion26 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabrizio D'Ascenzo, A.O.U. Città della Salute e della Scienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04878133
- Sponsor's protocol ID
- OCT - 001621
- Acronym
- OCT-CONTACT
- Status last verified
- Sep 2026
- First submitted
- 5 May 2021
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OCT Guided vs COmplete Pci in patieNts With sT Segment Elevation myocArdial infarCtion and mulTivessel Disease
- ClinicalTrials.gov ID
- NCT04878133
- Acronym / sponsor ID
- OCT-CONTACT / OCT - 001621
- Conditions
- Acute Coronary Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 26 Sep 2026 (actual)
- First posted
- 7 May 2021 (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.
STEMI patients with multivessel disease will be randomized to complete PCI versus PCI driven by high risk criteria of plaques evaluated with OCT
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Exsperimental Arm | Experimental | Diagnostic Test: OCT - optical coherence tomography |
| Control Arm | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with STEMI and residual non culprit CAD
- Informed consent
Key exclusion criteria (9 listed)
- Refusal or inability to provide informed consent.
- < 18 years of age
- Cardiogenic shock
- 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 |
|---|---|---|
| OCT - optical coherence tomographyThe 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. | Diagnostic test | Exsperimental Arm |
Primary outcome
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.
1 secondary outcome
Secondary efficacy end-points
Time frame: 24 mounth after the recruitment in the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCT - optical coherence tomography in people with Acute Coronary Syndrome, run by A.O.U. Città della Salute e della Scienza at 6 sites in Italy.
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 2 inclusion and 9 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: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 cardiovascular events (MACE) (time frame: 24 mounth after the recruitment in the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2026.