STEMIULTRA-STEMINCT05974930
Intravascular ULTRAsound-Guided PCI in Patients With ST-Elevation Myocardial Infarction
An observational study of STEMI and Intravascular Imaging, run by Aristotle University Of Thessaloniki.
Trial summary
The main goal of the ULTRA-STEMI trial is to investigate the prognostic impact of IVUS-guided PCI in patients with STEMI and correlate IVUS measurements with clinical, procedural, imaging and follow-up outcomes of interest. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STEMI, Intravascular Imaging, IVUS
- What is being tested?
- IVUS imaging for primary PCI guidance
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 30 Dec 2025
- Phase
- Observational
- 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
Study population: All adult patients presenting with STEMI undergoing primary PCI for a native coronary artery culprit lesion will undergo IVUS (at baseline, post-intervention and post-optimization) and post-PCI iFR.
Who may be able to join
- Patients with acute STEMI undergoing primary PCI within 12 hours of symptom onset according to the 4th universal definition of myocardial infarction.
- Age >18 years
- Individuals willing to voluntarily sign the consent and data protection forms before their inclusion in the clinical study.
Who cannot join
- Patients presenting with cardiogenic shock
- Patients with a known contraindication for primary PCI
- Pregnancy
- Presentation ≥12 hours after symptom onset
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Intravascular ULTRAsound-Guided PCI in Patients With ST-Elevation Myocardial Infarction: the ULTRA-STEMI Trial
The main goal of the ULTRA-STEMI trial is to investigate the prognostic impact of IVUS-guided PCI in patients with STEMI and correlate IVUS measurements with clinical, procedural, imaging and follow-up outcomes of interest.
Study participants will undergo primary PCI as per standardized procedures; IVUS will be performed at baseline, post-intervention and post-optimization. Manual thrombus aspiration will be performed according to clinical indications. The aspirated thrombi will be collected and scanned with micro-computed tomography (micro-CT). Also, angiographic and peri-procedural data will be gathered. Post-PCI instantaneous wave-free ratio (IFR) will also be performed to assess the severity of the residual coronary-artery stenosis, if any. All patients will be followed up for at least12 months for the adjudication of major adverse cardiovascular events.
Read the detailed description
The ULTRA-STEMI trial is a prospective investigator-initiated single-centre single-arm observational cohort study aiming to enroll 80 consecutive patients presenting with ST-segment elevation myocardial infarction (STEMI) and undergoing IVUS-guided primary PCI. IVUS will be performed at baseline, post-intervention and post-optimization. Baseline tissue characterization includes the morphological description of culprit lesion plaque and thrombus characteristics as assessed with IVUS. In patients with large thrombus burden, manual thrombus aspiration will be performed according to clinical indications. The aspirated thrombi will be collected and scanned with micro-computed tomography (micro-CT) to correlate IVUS measurements with micro-CT thrombus quantification. Also, angiographic data will be gathered to correlate IVUS measurements with pre-and post-PCI angiographic information. Post-PCI instantaneous wave-free ratio (IFR) will also be performed to assess the severity of the residual coronary-artery stenosis, if any. All patients will be followed up for at least 12 months for the adjudication of major adverse cardiovascular events.The primary endpoint will be target vessel failure at 12 months (defined as a composite of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization). The secondary outcomes of interest will be: radiation exposure, contrast use and kidney function effects. Other endpoints include clinical and angiographic outcomes along with post-PCI IVUS, iFR and micro-CT findings.
- Conditions
- STEMI, Intravascular Imaging, IVUS
- Being tested
- IVUS imaging for primary PCI guidance
- Keywords
- IVUS, Thrombus, STEMI
- Medical subject headings
- ST Elevation Myocardial Infarction, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVUS imaging for primary PCI guidanceDevice
Eagle Eye Platinum Intravascular ultrasound (IVUS) will be used to assess intra-coronary plaque, thrombus or stenosis in patients with STEMI. The device is FDA- and EMA-approved and routinely used in clinical practice. Quantitative and qualitative IVUS parameters will be collected and recorded for all participants to be correlated with clinical, imaging and angiographic outcomes of interest.
| Study group | Role | What they receive |
|---|---|---|
| Patients with STEMI undergoing IVUS-guided primary PCI | The ULTRA-STEMI trial will include consecutive patients with STEMI undergoing IVUS-guided primary PCI. All participants will undergo: IVUS intra-coronary imaging at baseline-, post-intervention and post-optimization. If manual thrombus aspiration is needed, the aspirated thrombotic material will be collected to be micro-CT scanned. Post-PCI iFR will be also performed in each participant. Clinical, angiographic and peri-procedural data will be collected. Each participant will be subject to telephone follow-up at 1, 6 and 12 months. Receives: Device: IVUS imaging for primary PCI guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of "Target vessel failure" at 12 months of follow-up in association with IVUS measurements
Follow-up will be obtained using online patient-reported outcome measurements by email or standardized telephone calls at 30 days, 6 months and 12 months after the procedure. Primary follow-up outcome of interest is the composite endpoint of target vessel failure (cardiac death, new-onset heart failure, target vessel myocardial infarction, clinically driven target vessel revascularization or target lesion revascularization).
Measured: 2 years
All-cause mortality at 12 months of follow-up in association with IVUS measurements
Co-primary study outcome will be the investigation of all-cause mortality (i.e., death from any cause) after hospitalization and during follow-up.
Measured: 2 years
Secondary outcomes (15)
In-hospital (post-PCI) adverse events in association with IVUS measurements
The composite endpoint of in-hospital (post-PCI) adverse events includes: cardiac tamponade, need for CABG, shock, in-hospital mortality, acute kidney failure, bleeding, stroke.
Measured: 2 years
Pre-procedural angiographic outcomes in association with IVUS measurements
Pre-procedural Thrombolysis in myocardial infarction (TIMI) flow, thrombus burden classification, culprit vessel, number of diseased vessels, and the SYNergy between percutaneous intervention with TAXus DES and cardiac surgery (SYNTAX) score will be recorded and associated with pre-procedural IVUS measurements. Higher SYNTAX score and lower TIMI flow represent greater obstruction in the diseased vessels.
Measured: 2 years
Post-procedural angiographic outcomes in association with IVUS measurements
Post-procedural TIMI flow, angiographically evident residual thrombus, no-reflow phenomenon, myocardial blush grade, and distal embolization will be recorded and associated with IVUS measurements.
Measured: 2 years
Post-PCI iFR measurement in association with IVUS measurements
iFR=ratio of distal coronary pressure (Pd) to the aortic pressure (Pa) during an isolated period during diastole.
Measured: 2 years
Microtomographic thrombus volume in association with IVUS measurements
Micro-CT derived volume of the extracted thrombotic material will be correlated with IVUS measurements.
Measured: 2 years
Microtomographic thrombus porosity in association with IVUS measurements
Micro-CT derived porosity of the extracted thrombotic material will be correlated with IVUS measurements.
Measured: 2 years
Microtomographic thrombus density in association with IVUS measurements
Micro-CT derived density of the extracted thrombotic material will be correlated with IVUS measurements.
Measured: 2 years
Νumber and type of stents in association with IVUS measurements
Νumber and type of stents used will be recorded and associated with IVUS measurements.
Measured: 2 years
Stent length and diameter in association with IVUS measurements
Stent length and diameter will be recorded and associated with IVUS measurements.
Measured: 2 years
Contrast volume in association with IVUS measurements
Volume of the contrast used will be recorded and associated with IVUS measurements.
Measured: 2 years
Radiation dose in association with IVUS measurements
Peri-procedural radiation dose will be recorded and associated with IVUS measurements.
Measured: 2 years
Procedural duration in association with IVUS measurements
Procedural duration will be recorded and associated with IVUS measurements.
Measured: 2 years
Post-PCI stent underexpansion, deformation or malapposition in association with baseline IVUS measurements
Stent underexpansion, deformation or malapposition (yes/no) will be recorded and associated with baseline IVUS measurements.
Measured: 2 years
Post-PCI edge dissection in association with baseline IVUS measurements
Edge dissection (yes/no) will be recorded and associated with baseline IVUS measurements.
Measured: 2 years
Post-PCI high plaque burden at stent edges, residual focal lesions or tissue protrusion through the stent struts in association with baseline IVUS measurements
High plaque burden at stent edges, residual focal lesions or tissue protrusion through the stent struts (yes/no) will be recorded and associated with baseline IVUS measurements.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for STEMIStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karagiannidis Efstratios, Aristotle University Of Thessaloniki
- Investigators
- Georgios Kassimis, MD, PhD, Principal investigator, 2ND Cardiology Department, Hippokrateion General Hospital of Thessaloniki, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974930
- Sponsor's protocol ID
- 69589
- Acronym
- ULTRA-STEMI
- Status last verified
- Jul 2023
- First submitted
- 16 Jul 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Groenland FTW, Mahmoud KD, Neleman T, Ziedses des Plantes AC, Scoccia A, Ligthart J, Witberg KT, Nuis RJ, den Dekker WK, Wilschut JM, Diletti R, Zijlstra F, Kardys I, Cummins P, Van Mieghem NM, Daemen J. Tissue characterisation and primary percutaneous coronary intervention guidance using intravascular ultrasound: rationale and design of the SPECTRUM study. Open Heart. 2022 Apr;9(1):e001955. doi: 10.1136/openhrt-2021-001955.
PubMed 35437257Karagiannidis E, Papazoglou AS, Sofidis G, Chatzinikolaou E, Keklikoglou K, Panteris E, Kartas A, Stalikas N, Zegkos T, Girtovitis F, Moysidis DV, Stefanopoulos L, Koupidis K, Hadjimiltiades S, Giannakoulas G, Arvanitidis C, Michaelson JS, Karvounis H, Sianos G. Micro-CT-Based Quantification of Extracted Thrombus Burden Characteristics and Association With Angiographic Outcomes in Patients With ST-Elevation Myocardial Infarction: The QUEST-STEMI Study. Front Cardiovasc Med. 2021 Apr 21;8:646064. doi: 10.3389/fcvm.2021.646064. eCollection 2021.
PubMed 33969012Didagelos M, Pagiantza A, Zegkos T, Zarra K, Angelopoulos V, Kouparanis A, Peteinidou E, Kassimis G, Karvounis H, Ziakas A. Low Molecular Weight Heparin in Improving RAO After Transradial Coronary Catheterization: The LOW-RAO Randomized Study. JACC Cardiovasc Interv. 2022 Aug 22;15(16):1686-1688. doi: 10.1016/j.jcin.2022.05.047. Epub 2022 Jul 27. No abstract available.
PubMed 35981848
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravascular ULTRAsound-Guided PCI in Patients With ST-Elevation Myocardial Infarction: the ULTRA-STEMI Trial
- ClinicalTrials.gov ID
- NCT05974930
- Acronym / sponsor ID
- ULTRA-STEMI / 69589
- Conditions
- STEMI, Intravascular Imaging, IVUS
- Keywords
- IVUS, Thrombus, STEMI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 3 Aug 2023 (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 main goal of the ULTRA-STEMI trial is to investigate the prognostic impact of IVUS-guided PCI in patients with STEMI and correlate IVUS measurements with clinical, procedural, imaging and follow-up outcomes of interest.
Study participants will undergo primary PCI as per standardized procedures; IVUS will be performed at baseline, post-intervention and post-optimization. Manual thrombus aspiration will be performed according to clinical indications. The aspirated thrombi will be collected and scanned with micro-computed tomography (micro-CT). Also, angiographic and peri-procedural data will be gathered. Post-PCI instantaneous wave-free ratio (IFR) will also be performed to assess the severity of the residual coronary-artery stenosis, if any. All patients will be followed up for at least12 months for the adjudication of major adverse cardiovascular events.
Detailed description
The ULTRA-STEMI trial is a prospective investigator-initiated single-centre single-arm observational cohort study aiming to enroll 80 consecutive patients presenting with ST-segment elevation myocardial infarction (STEMI) and undergoing IVUS-guided primary PCI. IVUS will be performed at baseline, post-intervention and post-optimization. Baseline tissue characterization includes the morphological description of culprit lesion plaque and thrombus characteristics as assessed with IVUS. In patients with large thrombus burden, manual thrombus aspiration will be performed according to clinical indications. The aspirated thrombi will be collected and scanned with micro-computed tomography (micro-CT) to correlate IVUS measurements with micro-CT thrombus quantification. Also, angiographic data will be gathered to correlate IVUS measurements with pre-and post-PCI angiographic information. Post-PCI instantaneous wave-free ratio (IFR) will also be performed to assess the severity of the residual coronary-artery stenosis, if any. All patients will be followed up for at least 12 months for the adjudication of major adverse cardiovascular events.The primary endpoint will be target vessel failure at 12 months (defined as a composite of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization). The secondary outcomes of interest will be: radiation exposure, contrast use and kidney function effects. Other endpoints include clinical and angiographic outcomes along with post-PCI IVUS, iFR and micro-CT findings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with STEMI undergoing IVUS-guided primary PCI | – | Device: IVUS imaging for primary PCI guidanceThe ULTRA-STEMI trial will include consecutive patients with STEMI undergoing IVUS-guided primary PCI. All participants will undergo: IVUS intra-coronary imaging at baseline-, post-intervention and post-optimization. If manual thrombus aspiration is needed, the aspirated thrombotic material will be collected to be micro-CT scanned. Post-PCI iFR will be also performed in each participant. Clinical, angiographic and peri-procedural data will be collected. Each participant will be subject to telephone follow-up at 1, 6 and 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients presenting with STEMI undergoing primary PCI for a native coronary artery culprit lesion will undergo IVUS (at baseline, post-intervention and post-optimization) and post-PCI iFR.
Key inclusion criteria (3 listed)
- Patients with acute STEMI undergoing primary PCI within 12 hours of symptom onset according to the 4th universal definition of myocardial infarction.
- Age >18 years
- Individuals willing to voluntarily sign the consent and data protection forms before their inclusion in the clinical study.
Key exclusion criteria (4 listed)
- Patients presenting with cardiogenic shock
- Patients with a known contraindication for primary PCI
- Pregnancy
- Presentation ≥12 hours after symptom onset
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 |
|---|---|---|
| IVUS imaging for primary PCI guidanceEagle Eye Platinum Intravascular ultrasound (IVUS) will be used to assess intra-coronary plaque, thrombus or stenosis in patients with STEMI. The device is FDA- and EMA-approved and routinely used in clinical practice. Quantitative and qualitative IVUS parameters will be collected and recorded for all participants to be correlated with clinical, imaging and angiographic outcomes of interest. | Device | Patients with STEMI undergoing IVUS-guided primary PCI |
Primary outcome
Rate of "Target vessel failure" at 12 months of follow-up in association with IVUS measurements
Time frame: 2 years
Follow-up will be obtained using online patient-reported outcome measurements by email or standardized telephone calls at 30 days, 6 months and 12 months after the procedure. Primary follow-up outcome of interest is the composite endpoint of target vessel failure (cardiac death, new-onset heart failure, target vessel myocardial infarction, clinically driven target vessel revascularization or target lesion revascularization).
All-cause mortality at 12 months of follow-up in association with IVUS measurements
Time frame: 2 years
Co-primary study outcome will be the investigation of all-cause mortality (i.e., death from any cause) after hospitalization and during follow-up.
15 secondary outcomes
In-hospital (post-PCI) adverse events in association with IVUS measurements
Time frame: 2 years
Pre-procedural angiographic outcomes in association with IVUS measurements
Time frame: 2 years
Post-procedural angiographic outcomes in association with IVUS measurements
Time frame: 2 years
Post-PCI iFR measurement in association with IVUS measurements
Time frame: 2 years
Microtomographic thrombus volume in association with IVUS measurements
Time frame: 2 years
Microtomographic thrombus porosity in association with IVUS measurements
Time frame: 2 years
Microtomographic thrombus density in association with IVUS measurements
Time frame: 2 years
Νumber and type of stents in association with IVUS measurements
Time frame: 2 years
Stent length and diameter in association with IVUS measurements
Time frame: 2 years
Contrast volume in association with IVUS measurements
Time frame: 2 years
Radiation dose in association with IVUS measurements
Time frame: 2 years
Procedural duration in association with IVUS measurements
Time frame: 2 years
Post-PCI stent underexpansion, deformation or malapposition in association with baseline IVUS measurements
Time frame: 2 years
Post-PCI edge dissection in association with baseline IVUS measurements
Time frame: 2 years
Post-PCI high plaque burden at stent edges, residual focal lesions or tissue protrusion through the stent struts in association with baseline IVUS measurements
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Background: PubMed 35437257Groenland FTW, Mahmoud KD, Neleman T, Ziedses des Plantes AC, Scoccia A, Ligthart J, Witberg KT, Nuis RJ, den Dekker WK, Wilschut JM, Diletti R, Zijlstra F, Kardys I, Cummins P, Van Mieghem NM, Daemen J. Tissue characterisation and primary percutaneous coronary intervention guidance using intravascular ultrasound: rationale and design of the SPECTRUM study. Open Heart. 2022 Apr;9(1):e001955. doi: 10.1136/openhrt-2021-001955.
- Background: PubMed 33969012Karagiannidis E, Papazoglou AS, Sofidis G, Chatzinikolaou E, Keklikoglou K, Panteris E, Kartas A, Stalikas N, Zegkos T, Girtovitis F, Moysidis DV, Stefanopoulos L, Koupidis K, Hadjimiltiades S, Giannakoulas G, Arvanitidis C, Michaelson JS, Karvounis H, Sianos G. Micro-CT-Based Quantification of Extracted Thrombus Burden Characteristics and Association With Angiographic Outcomes in Patients With ST-Elevation Myocardial Infarction: The QUEST-STEMI Study. Front Cardiovasc Med. 2021 Apr 21;8:646064. doi: 10.3389/fcvm.2021.646064. eCollection 2021.
- Background: PubMed 35981848Didagelos M, Pagiantza A, Zegkos T, Zarra K, Angelopoulos V, Kouparanis A, Peteinidou E, Kassimis G, Karvounis H, Ziakas A. Low Molecular Weight Heparin in Improving RAO After Transradial Coronary Catheterization: The LOW-RAO Randomized Study. JACC Cardiovasc Interv. 2022 Aug 22;15(16):1686-1688. doi: 10.1016/j.jcin.2022.05.047. Epub 2022 Jul 27. No abstract available.
- 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.
Georgios Kassimis, MD, PhD principal investigator
2ND Cardiology Department, Hippokrateion General Hospital of Thessaloniki, Greece
Questions about this trial
What is this clinical trial studying?
An observational study of STEMI and Intravascular Imaging, run by Aristotle University Of Thessaloniki.
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 4 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 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Georgios Kassimis, MD, PhD (+306936693916, gksup@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of "Target vessel failure" at 12 months of follow-up in association with IVUS measurements (time frame: 2 years). The study lists 2 primary outcomes in all. 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 NCT05974930, which also lists 3 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 3 Aug 2023.