ST Elevation Myocardial InfarctionPhase 2/3LOVEinSTEMINCT04063345
Long-term Clinical Outcomes of intraVascular Ultrasound-guided vs Angiography-guided Primary pErcutaneous Intervention in Patients With Acute ST Segment Elevated Myocardial Infarction
A Phase 2/3 study testing IVUS-guided PCI and Angiography-guided PCI in people with ST Elevation Myocardial Infarction, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
To examine the impact of IVUS guidance on clinical outcomes in the patient with Acute ST Segment Elevated Myocardial Infarction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevation Myocardial Infarction
- What is being tested?
- IVUS-guided PCI and Angiography-guided PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 1 Oct 2023
- Phase
- Phase 2/3
- 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
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:
- Having at least one infarct-related coronary artery, of which (1) the Culprit lesion is suitable for stenting (2) the reference diameter of culprit vessel is ≥ 2.5 mm but ≤ 4 mm (3) 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
- 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
- Anigographic 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
- Renal failure requiring or during dialysis
Trial locations and contacts
1 site in 1 country.
China1 site
Second affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Jun Jiang, MD, PhD, +86-13588706891, drjayj@hotmail.com
About this study
Official title: A Prospective, Open Label, Multicenter and Randomized Study of Clinical Outcomes of Intravascular Ultrasound -Guided and Angiography-Guided Primary Percutaneous Intervention in Patients With Acute ST Segment Elevated Myocardial Infarction
To examine the impact of IVUS guidance on clinical outcomes in the patient with Acute ST Segment Elevated Myocardial Infarction.
Read the detailed description
Intravascular ultrasound (IVUS) has been increasingly used as a guide for percutaneous coronary intervention (PCI) during elective as well as emergent clinical scenario. Recent small number randomized studies, large scale registries as well as meta-analysis have consistently demonstrated advantages of IVUS-guidance over angiography-guide alone with respect to the lower incident of death, myocardial infarction and target vessel revascularization.
There are sparse data available on the clinical impact of IVUS-guided PCI in the setting of acute myocardial infarction (AMI) and its use remains a matter of controversy as shown by previous studies. This study is to examine the impact of IVUS guidance on clinical outcomes in the patient with Acute ST Segment Elevated Myocardial Infarction (STEMI).
- Conditions
- ST Elevation Myocardial Infarction
- Being tested
- IVUS-guided PCI, Angiography-guided PCI
- Keywords
- STEMI, Intravascular ultrasound, Angiography, Primary percutaneous intervention
- 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.
IVUS-guided PCIProcedure or surgery
Performing intravascular ultrasound before or/and after percutaneous intervention
Angiography-guided PCIProcedure or surgery
Performing percutaneous intervention without intravascular ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| IVUS-guided PCI | Experimental | Percutaneous intervention under IVUS-guidance Receives: Procedure: IVUS-guided PCI |
| Angiography-guided PCI | Active comparator | Percutaneous intervention under angiograhy-guidance only Receives: Procedure: Angiography-guided PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac event (MACE) rate
Defined as cardiac death, myocardial infarction (MI, Q-wave and non-Q-wave) and target vessel revascularization (TVR)
Measured: 1 year
Secondary outcomes (10)
MACE rate
Measured: 2-3 years
Target lesion revascularization (TLR) rate
Measured: 2-3 years
Target lesion failure (TLF) rate
Measured: 2-3 years
TVR rate
Measured: 2-3 years
Target vessel failure (TVF) rate
Measured: 2-3 years
MI (Q-wave and non-Q-wave) rat
Measured: 2-3 years
Cardiac death rate
Measured: 2-3 years
Non-cardiac death rate
Measured: 2-3 years
All death (cardiac and non-cardiovascular) rate
Measured: 2-3 years
Stent Thrombosis (ST) rate (ARC definite/probable)
Measured: 2-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start1 Oct 2021 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ningbo No. 1 Hospital, First Affiliated Hospital of Wenzhou Medical University, Second Affiliated Hospital of Wenzhou Medical University, The First Affiliated Hospital of Xiamen University, Shanghai Chest Hospital, Taizhou Hospital
- Responsible party
- Sponsor
- Investigators
- Jian-an Wang, MD, PhD, Study chair, Second Affiliated Hospital of Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063345
- Sponsor's protocol ID
- SAHZJU CT015
- Acronym
- LOVEinSTEMI
- Status last verified
- Jan 2021
- First submitted
- 19 Aug 2019
- Last updated
- 29 Jan 2021
- 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 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open Label, Multicenter and Randomized Study of Clinical Outcomes of Intravascular Ultrasound -Guided and Angiography-Guided Primary Percutaneous Intervention in Patients With Acute ST Segment Elevated Myocardial Infarction
- ClinicalTrials.gov ID
- NCT04063345
- Acronym / sponsor ID
- LOVEinSTEMI / SAHZJU CT015
- Conditions
- ST Elevation Myocardial Infarction
- Keywords
- STEMI, Intravascular ultrasound, Angiography, Primary percutaneous intervention
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Ningbo No. 1 Hospital, First Affiliated Hospital of Wenzhou Medical University, Second Affiliated Hospital of Wenzhou Medical University, The First Affiliated Hospital of Xiamen University, Shanghai Chest Hospital, Taizhou Hospital
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 21 Aug 2019 (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.
To examine the impact of IVUS guidance on clinical outcomes in the patient with Acute ST Segment Elevated Myocardial Infarction.
Detailed description
Intravascular ultrasound (IVUS) has been increasingly used as a guide for percutaneous coronary intervention (PCI) during elective as well as emergent clinical scenario. Recent small number randomized studies, large scale registries as well as meta-analysis have consistently demonstrated advantages of IVUS-guidance over angiography-guide alone with respect to the lower incident of death, myocardial infarction and target vessel revascularization.
There are sparse data available on the clinical impact of IVUS-guided PCI in the setting of acute myocardial infarction (AMI) and its use remains a matter of controversy as shown by previous studies. This study is to examine the impact of IVUS guidance on clinical outcomes in the patient with Acute ST Segment Elevated Myocardial Infarction (STEMI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVUS-guided PCI | Experimental | Procedure: IVUS-guided PCIPercutaneous intervention under IVUS-guidance |
| Angiography-guided PCI | Active comparator | Procedure: Angiography-guided PCIPercutaneous intervention under angiograhy-guidance only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Clinical inclusion criteria:
- Angiographic inclusion criteria:
Key exclusion criteria (15 listed)
- Clinical exclusion criteria:
- Anigographic Exclusion Criteria:
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-guided PCIPerforming intravascular ultrasound before or/and after percutaneous intervention | Procedure or surgery | IVUS-guided PCI |
| Angiography-guided PCIPerforming percutaneous intervention without intravascular ultrasound guidance | Procedure or surgery | Angiography-guided PCI |
Primary outcome
Major adverse cardiac event (MACE) rate
Time frame: 1 year
Defined as cardiac death, myocardial infarction (MI, Q-wave and non-Q-wave) and target vessel revascularization (TVR)
10 secondary outcomes
MACE rate
Time frame: 2-3 years
Target lesion revascularization (TLR) rate
Time frame: 2-3 years
Target lesion failure (TLF) rate
Time frame: 2-3 years
TVR rate
Time frame: 2-3 years
Target vessel failure (TVF) rate
Time frame: 2-3 years
MI (Q-wave and non-Q-wave) rat
Time frame: 2-3 years
Cardiac death rate
Time frame: 2-3 years
Non-cardiac death rate
Time frame: 2-3 years
All death (cardiac and non-cardiovascular) rate
Time frame: 2-3 years
Stent Thrombosis (ST) rate (ARC definite/probable)
Time frame: 2-3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
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ST Elevation Myocardial Infarction
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.
Jian-an Wang, MD, PhD study chair
Second Affiliated Hospital of Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing IVUS-guided PCI and Angiography-guided PCI in people with ST Elevation Myocardial Infarction, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site 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 8 inclusion and 15 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 29 Jan 2021. 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 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jun Jiang, MD, PhD (+86-13588706891, drjayj@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac event (MACE) rate (time frame: 1 year). 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 29 Jan 2021.