ST Elevation Myocardial InfarctionSPECTRUMNCT05007535
Tissue Characterization and Primary Percutaneous Coronary Intervention Guidance Using Intravascular Ultrasound
An observational study of ST Elevation Myocardial Infarction and Acute Myocardial Infarction, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
This prospective, single arm, observational cohort study is designed to assess the safety and efficacy of (high-definition) intravascular ultrasound (HD-IVUS) as guidance for primary percutaneous coronary intervention (PCI) and to assess culprit lesion plaque characteristics and thrombus morphology in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevation Myocardial Infarction, Acute Myocardial Infarction, Coronary Artery Disease
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Nov 2020to 2 Feb 2023
- 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: Patients presenting with ST-elevation myocardial infarction eligible for primary percutaneous coronary intervention.
Who may be able to join
- Native coronary artery culprit lesion, angiographically
- Culprit vessel reference diameter ≥ 2.25 mm, angiographically
Who cannot join
- Cardiogenic shock
- Presentation > 12 hours after symptom onset
Trial locations and contacts
1 site in 1 country.
About this study
This prospective, single arm, observational cohort study is designed to assess the safety and efficacy of (high-definition) intravascular ultrasound (HD-IVUS) as guidance for primary percutaneous coronary intervention (PCI) and to assess culprit lesion plaque characteristics and thrombus morphology in patients with ST-elevation myocardial infarction (STEMI).
Objectives:
- To assess clinical outcomes after IVUS-guided primary PCI in STEMI patients.
- To assess IVUS-guided optimization in STEMI patients.
- To assess culprit lesion plaque characteristics in STEMI patients with HD-IVUS.
- To assess and quantify thrombus in STEMI patients with HD-IVUS.
- To explore HD-IVUS derived predictors for clinically relevant aspiration thrombectomy.
Read the detailed description
The SPECTRUM study is an investigator-initiated, single-center, prospective, single arm, observational cohort study investigating the safety and efficacy of (HD)-IVUS as guidance for primary PCI in 200 patients with STEMI. This study enables the assessment of culprit lesion plaque characteristics and thrombus morphology with a 40-60 MHz HD-IVUS catheter.
All study patients will have a protocolized pre-intervention IVUS pullback directly after recanalization (so before any lesion preparation, i.e. balloon dilatation, aspiration thrombectomy or stent placement) and a post-intervention IVUS pullback. Subsequently, if IVUS-guided optimization is performed, a final pullback is highly recommended and considered as the post-optimization IVUS pullback.
The primary study outcomes are target vessel failure at 12 months and incidence of IVUS-guided optimization. More information on outcome measures is provided in the section below.
- Conditions
- ST Elevation Myocardial Infarction, Acute Myocardial Infarction, Coronary Artery Disease, Percutaneous Coronary Intervention, Intravascular Ultrasound, Thrombus
- Keywords
- Invasive Coronary Imaging
- Medical subject headings
- ST Elevation Myocardial Infarction, Coronary Artery Disease, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HD-IVUS-guided primary PCI | Prospective, single arm, observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Vessel Failure (TVF)
A composite of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization
Measured: 12 Months
IVUS-guided optimization
Incidence of IVUS-guided additional balloon dilatation or stent placement after angiographically successful PCI
Measured: Procedural
Secondary outcomes (9)
TVF
A composite of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization
Measured: 30 Days
Major Adverse Cardiovascular Events (MACE)
A composite of all-cause mortality, any myocardial infarction and repeat revascularization
Measured: 30 Days
Major Adverse Cardiovascular Events (MACE)
A composite of all-cause mortality, any myocardial infarction and repeat revascularization
Measured: 12 Months
Individual Components of TVF and MACE
Individual components of the composite endpoints
Measured: 30 Days
Individual Components of TVF and MACE
Individual components of the composite endpoints
Measured: 12 months
Major Intraprocedural Complications
Including type C-F dissections, perforations, slow flow or no-reflow, major side branch occlusion (> 2 mm)
Measured: Procedural
Angiographic Endpoints
Including final TIMI flow and final myocardial blush grade
Measured: Procedural
IVUS endpoints (continuous)
At least the following continuous variables will be assessed for the first 100 patients with sufficient HD-IVUS pullbacks:
- Minimal lumen area
- Thrombus containing frames
- Thrombus maximum angle
- Minimal stent area
Structured analysis of the HD-IVUS pullbacks will be performed with dedicated invasive imaging analysis software.
Measured: Procedural
IVUS endpoints (categorical)
At least the following categorical variables will be assessed for the first 100 patients with sufficient HD-IVUS pullbacks:
- Plaque rupture
- Convex calcium (nodule)
- Thrombus type
- Plaque type
- Thrombus protrusion
- Underexpansion
- Edge dissection
- Hematoma
- High plaque burden at stent edges
- Residual focal lesion
- Malapposition
Structured analysis of the HD-IVUS pullbacks will be performed with dedicated invasive imaging analysis software.
Measured: Procedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start10 Nov 2020
- Primary completion2 Feb 2023 (estimated)
- Study completion2 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Erasmus 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Acist Medical Systems, MicroPort CRM
- Responsible party
- Principal investigator, Joost Daemen, Erasmus Medical Center
- Investigators
- Joost Daemen, MD PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05007535
- Sponsor's protocol ID
- SPECTRUM
- Acronym
- SPECTRUM
- Status last verified
- Jan 2023
- First submitted
- 21 Apr 2021
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Groenland FTW, Ziedses des Plantes AC, Neleman T, Scoccia A, Ligthart JMR, Witberg KT, Mahmoud KD, Nuis RJ, den Dekker WK, Wilschut JM, Diletti R, Zijlstra F, Van Mieghem NM, Daemen J. Culprit lesion plaque characterization and thrombus grading by high-definition intravascular ultrasound in patients with ST-segment elevation myocardial infarction. Catheter Cardiovasc Interv. 2023 Aug;102(2):191-199. doi: 10.1002/ccd.30699. Epub 2023 May 26.
PubMed 37232425Groenland 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 35437257
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Characterization and Primary Percutaneous Coronary Intervention Guidance Using Intravascular Ultrasound
- ClinicalTrials.gov ID
- NCT05007535
- Acronym / sponsor ID
- SPECTRUM / SPECTRUM
- Conditions
- ST Elevation Myocardial Infarction, Acute Myocardial Infarction, Coronary Artery Disease, Percutaneous Coronary Intervention, Intravascular Ultrasound, Thrombus
- Keywords
- Invasive Coronary Imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Acist Medical Systems, MicroPort CRM
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 2 Feb 2023 (estimated)
- Study completion
- 2 Feb 2023 (estimated)
- First posted
- 16 Aug 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.
This prospective, single arm, observational cohort study is designed to assess the safety and efficacy of (high-definition) intravascular ultrasound (HD-IVUS) as guidance for primary percutaneous coronary intervention (PCI) and to assess culprit lesion plaque characteristics and thrombus morphology in patients with ST-elevation myocardial infarction (STEMI).
Objectives:
- To assess clinical outcomes after IVUS-guided primary PCI in STEMI patients.
- To assess IVUS-guided optimization in STEMI patients.
- To assess culprit lesion plaque characteristics in STEMI patients with HD-IVUS.
- To assess and quantify thrombus in STEMI patients with HD-IVUS.
- To explore HD-IVUS derived predictors for clinically relevant aspiration thrombectomy.
Detailed description
The SPECTRUM study is an investigator-initiated, single-center, prospective, single arm, observational cohort study investigating the safety and efficacy of (HD)-IVUS as guidance for primary PCI in 200 patients with STEMI. This study enables the assessment of culprit lesion plaque characteristics and thrombus morphology with a 40-60 MHz HD-IVUS catheter.
All study patients will have a protocolized pre-intervention IVUS pullback directly after recanalization (so before any lesion preparation, i.e. balloon dilatation, aspiration thrombectomy or stent placement) and a post-intervention IVUS pullback. Subsequently, if IVUS-guided optimization is performed, a final pullback is highly recommended and considered as the post-optimization IVUS pullback.
The primary study outcomes are target vessel failure at 12 months and incidence of IVUS-guided optimization. More information on outcome measures is provided in the section below.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HD-IVUS-guided primary PCI | – | –Prospective, single arm, observational |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting with ST-elevation myocardial infarction eligible for primary percutaneous coronary intervention.
Key inclusion criteria (2 listed)
- Native coronary artery culprit lesion, angiographically
- Culprit vessel reference diameter ≥ 2.25 mm, angiographically
Key exclusion criteria (2 listed)
- Cardiogenic shock
- 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.
Primary outcome
Target Vessel Failure (TVF)
Time frame: 12 Months
A composite of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization
IVUS-guided optimization
Time frame: Procedural
Incidence of IVUS-guided additional balloon dilatation or stent placement after angiographically successful PCI
9 secondary outcomes
TVF
Time frame: 30 Days
Major Adverse Cardiovascular Events (MACE)
Time frame: 30 Days
Major Adverse Cardiovascular Events (MACE)
Time frame: 12 Months
Individual Components of TVF and MACE
Time frame: 30 Days
Individual Components of TVF and MACE
Time frame: 12 months
Major Intraprocedural Complications
Time frame: Procedural
Angiographic Endpoints
Time frame: Procedural
IVUS endpoints (continuous)
Time frame: Procedural
IVUS endpoints (categorical)
Time frame: Procedural
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Derived from this study: PubMed 37232425Groenland FTW, Ziedses des Plantes AC, Neleman T, Scoccia A, Ligthart JMR, Witberg KT, Mahmoud KD, Nuis RJ, den Dekker WK, Wilschut JM, Diletti R, Zijlstra F, Van Mieghem NM, Daemen J. Culprit lesion plaque characterization and thrombus grading by high-definition intravascular ultrasound in patients with ST-segment elevation myocardial infarction. Catheter Cardiovasc Interv. 2023 Aug;102(2):191-199. doi: 10.1002/ccd.30699. Epub 2023 May 26.
- Derived from this study: 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.
- Individual participant dataSharing planned: No
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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.
Joost Daemen, MD PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ST Elevation Myocardial Infarction and Acute Myocardial Infarction, run by Erasmus 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 2 inclusion and 2 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 18 Jan 2023. 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?
Target Vessel Failure (TVF) (time frame: 12 Months). 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 NCT05007535, which also lists 2 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 18 Jan 2023.