Coronary Artery DiseaseSTEMI-OCTNCT02384824
Delayed Plaque Morphology in Patients With STEMI After Thrombus Aspiration During Primary PCI
An observational study of Coronary Artery Disease and Myocardial Infarction, run by Jian'an Wang,MD,PhD.
Trial summary
The purpose of this study is to characterize the plaque morphology in patients with acute STEMI by OCT after aspiration thrombectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Myocardial Infarction
- What is being tested?
- Primary Percutaneous Intervention
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Oct 2017
- 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 with acute STEMI
Who may be able to join
- Clinical inclusion criteria:
- Age > 18 years
- Onset of STEMI > 30 minutes, but < 12 hours
- ST segment elevation in at least 2 contiguous leads of≥ 1mm or newly developed LBBB on ECG
- Willing and able to provide informed consent
- Angiographic inclusion criteria:
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- Having at least one infarct-related coronary artery, of which
- The Culprit lesion is suitable for stenting;
- The reference diameter of culprit vessel is ≥ 2.5 mm but ≤ 4 mm;
- The TIMI flow is ≤ 1 in culprit lesion segment prior to guide wire crossing
- No excessive tortuosity and calcification in the culprit lesion segment that allowing stent implantation
Who cannot join
- 1. Clinical exclusion criteria:
- Contraindicating to any concomitant study medications
- Having cardiogenic shock with hemodynamic instability
- A history of bleeding diathesis or known coagulopathy
- A history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months; or a history of intracranial tumor, aneurysm or arteriovenous malformations; or a history of active peptic ulcer or active gastrointestinal (GI) bleeding within the past 2 months; or planned major procedure within 6 weeks; or known platelet count < 100,000 /mm3 or Hb < 10 g/dL
- Planned surgery which may cause discontinuation of ADP-receptor antagonist
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- Other serious illness (e.g., cancer) that may reduce life expectancy to less than 1 year
- Repeated MI within 7 days of hospitalization for acute MI
- Angiographic exclusion criteria:
- Bifurcated lesion unable to identify the culprit lesion
- The culprit lesion is located in the left main artery
- Diffusive lesions without distinguishable culprit lesion
- Previous stent implantation in the culprit lesion segment or STEMI caused by stent thrombosis
- Likely CABG procedure within 30 days
About this study
Official title: Evaluation of Delayed Plaque Morphology by Optical Coherence Tomography (OCT) in Patients With Acute ST Segment Elevated Myocardial Infarction (STEMI) After Thrombus Aspiration During Primary Percutaneous Intervention (PCI)
The purpose of this study is to characterize the plaque morphology in patients with acute STEMI by OCT after aspiration thrombectomy.
Read the detailed description
Current guideline for treating acute STEMI is primarily PCI and stent placement in the infarct-related coronary artery. But, the underlying plaque morphology is not routinely identified due to the limited resolution of conventional imagine modalities. However, autopsy studies have shown that there are different atherosclerotic plaque morphologies involving in acute thrombotic occlusion of coronary arteries other than atherosclerotic plaque rupture, such as plaque erosion, calcified nodule, etc. Some studies have suggested that PCI and stenting might not always be necessary in about 30 - 40% of ACS patients, and an alternative treatment strategy is needed for these patients based on the characteristics of plaque morphology.
100 subjects who meet the inclusion/exclusion criteria will undergo emergent angiography and followings: If no thrombus was observed, OCT examination will be performed in the target vessel;
If thrombosis was confirmed, the subject will undergo manual aspiration thrombectomy and antiplatelet therapy, and TIMI flow will be assessed:
If TIMI flow grade < 3, the subject will receive stent implantation as the standard of care followed by OCT examination; If TIMI flow grade of 3, the subject will not receive stent implantation but will be sent to CCU for monitoring and antiplatelet treatment, and have a repeat angiography and OCT examination at Day 7; within the 7days post STEMI, ischemia-driven angiography and/or PCI are allowed, and an OCT examination will be performed in these subject before PCI.
Patients without undergoing initial stent implantation will have scheduled 30-day and 12-month follow-ups for clinical outcomes.
- Conditions
- Coronary Artery Disease, Myocardial Infarction
- Being tested
- Primary Percutaneous Intervention
- Medical subject headings
- Coronary Artery Disease, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Percutaneous InterventionProcedure or surgery
angiography, manual aspiration thrombectomy and antiplatelet therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
plaque morphology by OCT
Measured: at the 7th day post PCI/aspiration thrombectomy
Secondary outcomes (2)
Re-hospitalization due to cardiac symptoms
Measured: 30 days & 12 months
Myocardial infarction related to the target vessel
Measured: 30 days & 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jian'an Wang,MD,PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jian'an Wang,MD,PhD, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02384824
- Sponsor's protocol ID
- SAHZJU CT003
- Acronym
- STEMI-OCT
- Status last verified
- Mar 2015
- First submitted
- 15 Jan 2015
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Delayed Plaque Morphology by Optical Coherence Tomography (OCT) in Patients With Acute ST Segment Elevated Myocardial Infarction (STEMI) After Thrombus Aspiration During Primary Percutaneous Intervention (PCI)
- ClinicalTrials.gov ID
- NCT02384824
- Acronym / sponsor ID
- STEMI-OCT / SAHZJU CT003
- Conditions
- Coronary Artery Disease, Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jian'an Wang,MD,PhDUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 10 Mar 2015 (estimated)
- 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 purpose of this study is to characterize the plaque morphology in patients with acute STEMI by OCT after aspiration thrombectomy.
Detailed description
Current guideline for treating acute STEMI is primarily PCI and stent placement in the infarct-related coronary artery. But, the underlying plaque morphology is not routinely identified due to the limited resolution of conventional imagine modalities. However, autopsy studies have shown that there are different atherosclerotic plaque morphologies involving in acute thrombotic occlusion of coronary arteries other than atherosclerotic plaque rupture, such as plaque erosion, calcified nodule, etc. Some studies have suggested that PCI and stenting might not always be necessary in about 30 - 40% of ACS patients, and an alternative treatment strategy is needed for these patients based on the characteristics of plaque morphology.
100 subjects who meet the inclusion/exclusion criteria will undergo emergent angiography and followings: If no thrombus was observed, OCT examination will be performed in the target vessel;
If thrombosis was confirmed, the subject will undergo manual aspiration thrombectomy and antiplatelet therapy, and TIMI flow will be assessed:
If TIMI flow grade < 3, the subject will receive stent implantation as the standard of care followed by OCT examination; If TIMI flow grade of 3, the subject will not receive stent implantation but will be sent to CCU for monitoring and antiplatelet treatment, and have a repeat angiography and OCT examination at Day 7; within the 7days post STEMI, ischemia-driven angiography and/or PCI are allowed, and an OCT examination will be performed in these subject before PCI.
Patients without undergoing initial stent implantation will have scheduled 30-day and 12-month follow-ups for clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with acute STEMI
Key inclusion criteria (11 listed)
- Clinical inclusion criteria:
- Angiographic inclusion criteria:
Key exclusion criteria (14 listed)
- Contraindicating to any concomitant study medications
- Having cardiogenic shock with hemodynamic instability
- A history of bleeding diathesis or known coagulopathy
- A history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months; or a history of intracranial tumor, aneurysm or arteriovenous malformations; or a history of active peptic ulcer or active gastrointestinal (GI) bleeding within the past 2 months; or planned major procedure within 6 weeks; or known platelet count < 100,000 /mm3 or Hb < 10 g/dL
- Planned surgery which may cause discontinuation of ADP-receptor antagonist
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 |
|---|---|---|
| Primary Percutaneous Interventionangiography, manual aspiration thrombectomy and antiplatelet therapy | Procedure or surgery | – |
Primary outcome
plaque morphology by OCT
Time frame: at the 7th day post PCI/aspiration thrombectomy
2 secondary outcomes
Re-hospitalization due to cardiac symptoms
Time frame: 30 days & 12 months
Myocardial infarction related to the target vessel
Time frame: 30 days & 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Myocardial Infarction, run by Jian'an Wang,MD,PhD.
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 11 inclusion and 14 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 10 Mar 2015. 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?
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?
plaque morphology by OCT (time frame: at the 7th day post PCI/aspiration thrombectomy). 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 10 Mar 2015.