ST Elevation Myocardial InfarctionNCT04929158
Comparison of Clinical Outcomes of IVUS -Guided and Angiography-guided PCI in Patients With Acute STEMI
A study testing Intravascular Ultrasound (IVUS) -guided Primary Percutaneous Intervention (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 compare the long-term clinical outcomes of IVUS-guided vs angiography-guided PCI in patients with acute STEMI 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?
- Intravascular Ultrasound (IVUS) -guided Primary Percutaneous Intervention (PCI)
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteChina
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 (CI) Criteria: CI. Age > 18 years C2. Onset of STEMI > 30 minutes, but < 12 hours C3. ST segment elevation in at least 2 contiguous leads of≥ 1mm or newly developed LBBB on ECG C4. Willing and able to provide informed consent
- Angiographic Inclusion (AI) Criteria (visual estimate) AI1. 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 AI2. No excessive tortuosity and calcification in the culprit lesion segment that allowing stent implantation
Who cannot join
- Clinical Exclusion (CE) Criteria CE1. Contraindicating to any concomitant study medications CE2. Having cardiogenic shock with hemodynamic instability CE3. A history of bleeding diathesis or known coagulopathy CE4. 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 CE5. Planned surgery which may cause discontinuation of ADP-receptor antagonist CE6. Other serious illness (e.g., cancer) that may reduce life expectancy to less than 1 year CE7. Repeated MI within 7 days of hospitalization for acute MI
- Angiographic Exclusion (AE) Criteria (visual estimate) AE1. Bifurcated lesion unable to identify the culprit lesion AE2. The culprit lesion is located in the left main artery. AE3. Diffusive lesions without distinguishable culprit lesion AE4. Previous stent implantation in the culprit lesion segment or STEMI caused by stent thrombosis AE5. Likely CABG procedure within 30 days
Trial locations and contacts
1 site in 1 country.
China1 site
- Available
2nd Affiliated Hospital, School of Medicine at Zhejiang University
Hangzhou, Zhejiang, 310009
Liang Dong, PhD, +13858188861, gemsangel@163.com
Jianan Wang, MD, PhD
About this study
Official title: Comparison of Clinical Outcomes of Intravascular Ultrasound (IVUS) -Guided and Angiography-Guided Primary Percutaneous Intervention (PCI) in Patients With Acute ST Segment Elevated Myocardial Infarction (STEMI)
To compare the long-term clinical outcomes of IVUS-guided vs angiography-guided PCI in patients with acute STEMI
Read the detailed description
This study is a prospective, multicenter, randomized controlled trial, led by the second hospital affiliated to zhejiang university school of medicine, A total of 10 hospitals in zhejiang province interventional cardiovascular center to participate in, plan to recruit 200 STEMI patients.
Subjects according to the proportion of 1:1 were randomly allocated to two treatment groups.(Experimental group (IVUS) steering group or control group (imaging) steering group.) Plan 10 centers in 200 men and women aged 18 and older patients, according to the American heart association and the United States The college of cardiology interventional treatment guidelines for the participants.
Each center recruiting number does not exceed 40% of the total plan recruitment.
- Conditions
- ST Elevation Myocardial Infarction
- Being tested
- Intravascular Ultrasound (IVUS) -guided Primary Percutaneous Intervention (PCI)
- Keywords
- ST 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.
Intravascular Ultrasound (IVUS) -guided Primary Percutaneous Intervention (PCI)Procedure or surgery
Also called Angiography-guided Primary Percutaneous Intervention (PCI)
Preoperative criminal vascular assessment； The criminal vascular assessment after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
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
- Expanded access
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang University, First Affiliated Hospital of Wenzhou Medical University, Taizhou First People's Hospital, Changxing People's Hospital
- Responsible party
- Sponsor
- Investigators
- Jianan Wang, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929158
- Sponsor's protocol ID
- clinical 2020-401
- Status last verified
- Jan 2024
- First submitted
- 7 Jun 2021
- Last updated
- 24 Jan 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Outcomes of Intravascular Ultrasound (IVUS) -Guided and Angiography-Guided Primary Percutaneous Intervention (PCI) in Patients With Acute ST Segment Elevated Myocardial Infarction (STEMI)
- ClinicalTrials.gov ID
- NCT04929158
- Acronym / sponsor ID
- clinical 2020-401
- Conditions
- ST Elevation Myocardial Infarction
- Keywords
- ST Elevation Myocardial Infarction，
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Zhejiang University, First Affiliated Hospital of Wenzhou Medical University, Taizhou First People's Hospital, Changxing People's Hospital
- First posted
- 18 Jun 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.
To compare the long-term clinical outcomes of IVUS-guided vs angiography-guided PCI in patients with acute STEMI
Detailed description
This study is a prospective, multicenter, randomized controlled trial, led by the second hospital affiliated to zhejiang university school of medicine, A total of 10 hospitals in zhejiang province interventional cardiovascular center to participate in, plan to recruit 200 STEMI patients.
Subjects according to the proportion of 1:1 were randomly allocated to two treatment groups.(Experimental group (IVUS) steering group or control group (imaging) steering group.) Plan 10 centers in 200 men and women aged 18 and older patients, according to the American heart association and the United States The college of cardiology interventional treatment guidelines for the participants.
Each center recruiting number does not exceed 40% of the total plan recruitment.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- -Clinical Inclusion (CI) Criteria: CI. Age > 18 years C2. Onset of STEMI > 30 minutes, but < 12 hours C3. ST segment elevation in at least 2 contiguous leads of≥ 1mm or newly developed LBBB on ECG C4. Willing and able to provide informed consent
- Angiographic Inclusion (AI) Criteria (visual estimate) AI1. 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 AI2. No excessive tortuosity and calcification in the culprit lesion segment that allowing stent implantation
Key exclusion criteria (2 listed)
- Clinical Exclusion (CE) Criteria CE1. Contraindicating to any concomitant study medications CE2. Having cardiogenic shock with hemodynamic instability CE3. A history of bleeding diathesis or known coagulopathy CE4. 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 CE5. Planned surgery which may cause discontinuation of ADP-receptor antagonist CE6. Other serious illness (e.g., cancer) that may reduce life expectancy to less than 1 year CE7. Repeated MI within 7 days of hospitalization for acute MI
- Angiographic Exclusion (AE) Criteria (visual estimate) AE1. Bifurcated lesion unable to identify the culprit lesion AE2. The culprit lesion is located in the left main artery. AE3. Diffusive lesions without distinguishable culprit lesion AE4. Previous stent implantation in the culprit lesion segment or STEMI caused by stent thrombosis AE5. Likely CABG procedure within 30 days
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 |
|---|---|---|
| Intravascular Ultrasound (IVUS) -guided Primary Percutaneous Intervention (PCI)Also: Angiography-guided Primary Percutaneous Intervention (PCI)Preoperative criminal vascular assessment； The criminal vascular assessment after surgery | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
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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.
Jianan Wang principal investigator
Second Affiliated Hospital, 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 study testing Intravascular Ultrasound (IVUS) -guided Primary Percutaneous Intervention (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 5 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 24 Jan 2024. 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.
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 Liang Dong (13858188861, gemsangel@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 24 Jan 2024.