ST-segment Elevation Myocardial InfarctionNCT03062826
EROSION II: OCT Guided PPCI in STEMI
An observational study of ST-segment Elevation Myocardial Infarction, run by Harbin Medical University at 16 sites in China.
Trial summary
This protocol describes a prospective, multi-center study intended to test the hypothesis that patients with STEMI caused by plaque rupture or plaque erosion without obstructive stenosis (diameter stenosis <70%) can be stabilized by effective antithrombotic treatment without stent implantation, thereby avoiding both… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ST-segment Elevation Myocardial Infarction
- What is being tested?
- dual antiplatelet therapy (aspirin + ticagrelor or aspirin + clopidogrel)
- How many people
- 347 participants
- Where
- 16 sitesChina
- Study dates
- 11 Jan 2017to 1 Mar 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population is STEMI patients who undergo primary cardiac catheterization.
Who may be able to join
- Men or non-pregnant women >18 years of age and < 75 years of age.
- Patients undergo cardiac catheterization for STEMI. STEMI will be defined as continuous chest pain for >30 minutes, arrival at the hospital within 24 hours from chest pain onset, ST-segment elevation >0.1 mV in at least two contiguous leads, or new left bundle-branch block on the 12-lead electrocardiogram (ECG), and elevated cardiac markers (troponin T/I or creatine kinase-MB).
- Culprit lesion located in a native coronary artery.
- TIMI flow grade 3 and diameter stenosis < 70% by visual assessment on angiogram or MLA > 1.6mm2.
- Plaque erosion and rupture defined by OCT.
- Patients able to provide written informed consent.
Who cannot join
- Left ventricular ejection fraction < 30%.
- Lesions in LM, ostial LAD or RCA (defined as within 3 mm of the aorto-ostium).
- Long lesions, tortuous lesions and angulated lesions.
- More than 2 vessels with severe lesions.
- Massive residual thrombus after the thrombus aspiration.
- With the history of cardiopulmonary resuscitation (CPR), acute pulmonary edema and cardiac shock on the attacks.
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- Life expectancy < 1 year.
- Contraindication to the contrast media.
- Creatinine level > 2.0 mg/dL or end-stage kidney disease.
- Serious liver dysfunction.
- Patients with hemodynamic or electrical instability (including shock).
- Any contraindication against the use of ticagrelor.
- Investigator considers the patient is not suitable.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites
Beijing Luhe Hospital
Beijing, Beijing Municipality, 101100
China-Japan Union Hospital of Jilin University
Changchun, Jilin, 130000
The First Hospital of Jilin University
Changchun, Jilin, 130000
Sichuan Provincial People's Hospital
Chengdu, Sichuan
The First Affiliated Hospital of Dalian Medical University
Dalian, Shenyang
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150081
The First Hospital of Lanzhou University
Lanzhou, Gansu
Shenzhen Sun Yat-sen Cardiovascular Hospital
Shenzhen, Guangzhou
Hebei General Hospital
Shijiazhuang, Hebei
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi
Wuhan Asia Heart Hospital
Wuhan, Hubei
Xiamen Cardiovascular Hospital, Xiamen University
Xiamen, Fujian
General Hospital of Ningxia Medical University
Yinchuan, Ningxia
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu
About this study
Official title: A Prospective, Multi-center, Optical Coherence Tomography Guided Reperfusion Strategy in Patients With STEMI (EROSION II)
This protocol describes a prospective, multi-center study intended to test the hypothesis that patients with STEMI caused by plaque rupture or plaque erosion without obstructive stenosis (diameter stenosis <70%) can be stabilized by effective antithrombotic treatment without stent implantation, thereby avoiding both early and late complications related to percutaneous coronary intervention (PCI) with stent implantation. All the patients will be followed by intracoronary OCT and physiological assessment at 1-month and 12-month follow-up.
Read the detailed description
EROSION (Effective anti-thrombotic therapy without stenting: intravascular optical coherence tomography-based management in plaque erosion) study, a single-center, uncontrolled, prospective, proof-of concept study, showed that for patients with ACS caused by non-obstructive plaque erosion, conservative treatment with anti-thrombotic therapy without stenting may be an option. However, it is unknown whether plaque rupture with large lumen area and non-obstructive stenosis can be treated medically without stenting. EROSION II study is a prospective, multi-center, observational study to test the hypothesis that patients with STEMI caused by plaque rupture or plaque erosion without obstructive stenosis (diameter stenosis <70% by visual assessment) can be stabilized and healed by effective antithrombotic treatment without stent implantation. Patients presenting with STEMI within 24 hours from the onset of ischemic symptoms will be included for screening. Thrombus aspiration will be performed in patients with large thrombus burden and TIMI flow grade less than 2 to restore blood flow. OCT will be performed after antegrade blood flow restored to assess the underlying mechanism of culprit lesion including plaque rupture, plaque erosion, calcified nodule, spontaneous coronary artery dissection, and other uncommon reasons. OCT imaging of non-culprit vessels will be performed if feasible. Patients caused by plaque erosion or plaque rupture with minimal lumen area > 1.6mm2 or non-obstructive stenosis (diameter stenosis <70% by visual assessment) will be treated medically only with dual anti-platelet therapy for 12 months after discharge.
Serial OCT examination will be performed at 1-month and 12-month follow-up to assess the healing of original culprit lesion. Physiological assessment (either wire-based FFR or angio-based FFR) will also be performed to assess the hemodynamic function of culprit lesion. The primary endpoint is the reduction of thrombus burden assessed by OCT at 1-month follow-up. Presence of recurrent ischemia symptoms or positive FFR value are the indications for target lesion revascularization. Patients will be followed by phone calls by study coordinators or clinical visit at 1 month, 3 months, 6 months, 9 months and 12 months. Major cardiovascular adverse events (MACE) will be collected in all patients throughout the whole follow-up period. MACE is a composite of cardiac death, recurrent myocardial infarction, stroke, target lesion revascularization, major bleeding and unstable angina-induced rehospitalization.
Patients who do not meet the criteria after OCT imaging will be enrolled in registry cohort.
Blood sample will be obtained from artery sheath or coronary artery by aspiration catheter during the PCI procedure in selected sites. Blood samples will be stored at -80°C for potential biomarker test and multi-omics analysis.
- Being tested
- dual antiplatelet therapy (aspirin + ticagrelor or aspirin + clopidogrel)
- Keywords
- Optical Coherence Tomography, ST-segment Elevation Myocardial Infarction
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dual antiplatelet therapy (aspirin + ticagrelor or aspirin + clopidogrel)Drug
Patients who met the inclusion criteria will be treated with dual antiplatelet therapy (aspirin + ticagrelor or aspirin + clopidogrel).
| Study group | Role | What they receive |
|---|---|---|
| Patients with STEMI treated medically | Drug: dual antiplatelet therapy (aspirin + ticagrelor or aspirin + clopidogrel) for at least 12 months. Receives: Drug: dual antiplatelet therapy (aspirin + ticagrelor or aspirin + clopidogrel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of thrombus burden assessed by OCT
The efficacy will be assessed by 50% reduction in thrombus burden by OCT at 1 month.
Measured: 30 days
Secondary outcomes (4)
Major cardiovascular adverse events
In patients treated conservatively, the safety objectives are to evaluate the occurrence of any adverse events during 1, 3, 6, 9, 12 months follow up (re-infarction, re-hospitalization due to unstable angina, revascularization by PCI or CABG, cardiac death, stroke, and major bleeding).
Measured: 1, 3, 6, 9, 12 months after PCI
Major cardiovascular adverse events
compare the difference of clinical outcome in patients with plaque rupture and erosion.
Measured: 1 and 12 months after PCI
Effective flow area increase
Effective flow area increase
Measured: 1 and 12 months after PCI
Fractional flow reserve
either wire-based FFR or angio-based FFR
Measured: 1 and 12 months after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start11 Jan 2017
- Primary completion24 Feb 2022
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST-segment Elevation Myocardial InfarctionStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Salubris Pharmaceuticals Co., Ltd., Beijing Luhe Hospital, The First Hospital of Jilin University, China-Japan Union Hospital, Jilin University, The First Affiliated Hospital of Dalian Medical University, Shanxi Cardiovascular Hospital, Second Hospital of Shanxi Medical University, Hebei General Hospital, General Hospital of Ningxia Medical University, Sichuan Provincial People's Hospital, Affiliated Hospital of Jiangsu University, Xiamen Cardiovascular Hospital, Xiamen University, Shenzhen Sun Yat-sen Cardiovascular Hospital, LanZhou University, Sir Run Run Shaw Hospital, Wuhan Asia Heart Hospital
- Responsible party
- Principal investigator, Yu Bo, The Second Affiliated Hospital of Harbin Medical University
- Investigators
- Bo YU, MD, PhD, Study chair, The Second Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062826
- Sponsor's protocol ID
- HMUOCT-EROSIONII
- Status last verified
- Jun 2022
- First submitted
- 20 Feb 2017
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Optical Coherence Tomography Guided Reperfusion Strategy in Patients With STEMI (EROSION II)
- ClinicalTrials.gov ID
- NCT03062826
- Acronym / sponsor ID
- HMUOCT-EROSIONII
- Keywords
- Optical Coherence Tomography, ST-segment Elevation Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 347 participants (actual)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Collaborators
- Shenzhen Salubris Pharmaceuticals Co., Ltd., Beijing Luhe Hospital, The First Hospital of Jilin University, China-Japan Union Hospital, Jilin University, The First Affiliated Hospital of Dalian Medical University, Shanxi Cardiovascular Hospital, Second Hospital of Shanxi Medical University, Hebei General Hospital, General Hospital of Ningxia Medical University, Sichuan Provincial People's Hospital, Affiliated Hospital of Jiangsu University, Xiamen Cardiovascular Hospital, Xiamen University, Shenzhen Sun Yat-sen Cardiovascular Hospital, LanZhou University, Sir Run Run Shaw Hospital, Wuhan Asia Heart Hospital
- Study start
- 11 Jan 2017 (actual)
- Primary completion
- 24 Feb 2022 (actual)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 23 Feb 2017 (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 protocol describes a prospective, multi-center study intended to test the hypothesis that patients with STEMI caused by plaque rupture or plaque erosion without obstructive stenosis (diameter stenosis <70%) can be stabilized by effective antithrombotic treatment without stent implantation, thereby avoiding both early and late complications related to percutaneous coronary intervention (PCI) with stent implantation. All the patients will be followed by intracoronary OCT and physiological assessment at 1-month and 12-month follow-up.
Detailed description
EROSION (Effective anti-thrombotic therapy without stenting: intravascular optical coherence tomography-based management in plaque erosion) study, a single-center, uncontrolled, prospective, proof-of concept study, showed that for patients with ACS caused by non-obstructive plaque erosion, conservative treatment with anti-thrombotic therapy without stenting may be an option. However, it is unknown whether plaque rupture with large lumen area and non-obstructive stenosis can be treated medically without stenting. EROSION II study is a prospective, multi-center, observational study to test the hypothesis that patients with STEMI caused by plaque rupture or plaque erosion without obstructive stenosis (diameter stenosis <70% by visual assessment) can be stabilized and healed by effective antithrombotic treatment without stent implantation. Patients presenting with STEMI within 24 hours from the onset of ischemic symptoms will be included for screening. Thrombus aspiration will be performed in patients with large thrombus burden and TIMI flow grade less than 2 to restore blood flow. OCT will be performed after antegrade blood flow restored to assess the underlying mechanism of culprit lesion including plaque rupture, plaque erosion, calcified nodule, spontaneous coronary artery dissection, and other uncommon reasons. OCT imaging of non-culprit vessels will be performed if feasible. Patients caused by plaque erosion or plaque rupture with minimal lumen area > 1.6mm2 or non-obstructive stenosis (diameter stenosis <70% by visual assessment) will be treated medically only with dual anti-platelet therapy for 12 months after discharge.
Serial OCT examination will be performed at 1-month and 12-month follow-up to assess the healing of original culprit lesion. Physiological assessment (either wire-based FFR or angio-based FFR) will also be performed to assess the hemodynamic function of culprit lesion. The primary endpoint is the reduction of thrombus burden assessed by OCT at 1-month follow-up. Presence of recurrent ischemia symptoms or positive FFR value are the indications for target lesion revascularization. Patients will be followed by phone calls by study coordinators or clinical visit at 1 month, 3 months, 6 months, 9 months and 12 months. Major cardiovascular adverse events (MACE) will be collected in all patients throughout the whole follow-up period. MACE is a composite of cardiac death, recurrent myocardial infarction, stroke, target lesion revascularization, major bleeding and unstable angina-induced rehospitalization.
Patients who do not meet the criteria after OCT imaging will be enrolled in registry cohort.
Blood sample will be obtained from artery sheath or coronary artery by aspiration catheter during the PCI procedure in selected sites. Blood samples will be stored at -80°C for potential biomarker test and multi-omics analysis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with STEMI treated medically | – | Drug: dual antiplatelet therapy (aspirin + ticagrelor or aspirin + clopidogrel)Drug: dual antiplatelet therapy (aspirin + ticagrelor or aspirin + clopidogrel) for at least 12 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population is STEMI patients who undergo primary cardiac catheterization.
Key inclusion criteria (6 listed)
- Men or non-pregnant women >18 years of age and < 75 years of age.
- Patients undergo cardiac catheterization for STEMI. STEMI will be defined as continuous chest pain for >30 minutes, arrival at the hospital within 24 hours from chest pain onset, ST-segment elevation >0.1 mV in at least two contiguous leads, or new left bundle-branch block on the 12-lead electrocardiogram (ECG), and elevated cardiac markers (troponin T/I or creatine kinase-MB).
- Culprit lesion located in a native coronary artery.
- TIMI flow grade 3 and diameter stenosis < 70% by visual assessment on angiogram or MLA > 1.6mm2.
- Plaque erosion and rupture defined by OCT.
Key exclusion criteria (13 listed)
- Left ventricular ejection fraction < 30%.
- Lesions in LM, ostial LAD or RCA (defined as within 3 mm of the aorto-ostium).
- Long lesions, tortuous lesions and angulated lesions.
- More than 2 vessels with severe lesions.
- Massive residual thrombus after the thrombus aspiration.
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 |
|---|---|---|
| dual antiplatelet therapy (aspirin + ticagrelor or aspirin + clopidogrel)Patients who met the inclusion criteria will be treated with dual antiplatelet therapy (aspirin + ticagrelor or aspirin + clopidogrel). | Drug | Patients with STEMI treated medically |
Primary outcome
Reduction of thrombus burden assessed by OCT
Time frame: 30 days
The efficacy will be assessed by 50% reduction in thrombus burden by OCT at 1 month.
4 secondary outcomes
Major cardiovascular adverse events
Time frame: 1, 3, 6, 9, 12 months after PCI
Major cardiovascular adverse events
Time frame: 1 and 12 months after PCI
Effective flow area increase
Time frame: 1 and 12 months after PCI
Fractional flow reserve
Time frame: 1 and 12 months after PCI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Individual participant dataSharing planned: Yes
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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.
Bo YU, MD, PhD study chair
The Second Affiliated Hospital of Harbin Medical University
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ST-segment Elevation Myocardial Infarction, run by Harbin Medical University at 16 sites in China.
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 6 inclusion and 13 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 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in China. 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?
Reduction of thrombus burden assessed by OCT (time frame: 30 days). 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 27 Jun 2022.