Acute Myocardial InfarctionOPTIMALNCT03282773
Optimal Strategy of Primary PCI for Left Main Coronary Artery Occlusion Induced AMI
A study testing Deferred stent implantation and Immediate stent implantation in people with Acute Myocardial Infarction and Percutaneous Coronary Intervention, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This study will compare clinical outcomes of immediate stent implantation with deferred stent implantation(4-10days after primary angiography) for patients presented with acute myocardial infarction due to left main coronary artery occlusion. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Myocardial Infarction, Percutaneous Coronary Intervention
- What is being tested?
- Deferred stent implantation and Immediate stent implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2017to 31 Jul 2022
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of acute myocardial infarction occured within 12 hours
- Left main coronary artery occlusion confirmed by angiography
- Left main coronary artery occlusion (TIMI flow 0,1 or 2) confirmed by primary angiography, TIMI flow grade 3 achieved after pretreatment of thrombus aspiration or balloon dilatation
Who cannot join
- Life expectancy less than 1 years
- Cardiogenic shock
- Chronic kidney disease, stage 4 by KDOQI(GFR<30ml/min)
- Contraindications to aspirin or other anti-platelet drugs
- Allergy to contrast agent, rapamycin or paclitaxel
- Patients who are included in other ongoing trials
- Pregnant female
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Feng Zhang, M.D., 13917149007, zhang.feng@zs-hospital.sh.cn
Yang Gao, M.D., 18801970322, gysc20@163.com
About this study
Official title: Optimal Strategy of Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction Due to Unprotected Left Main Coronary Artery Occlusion
This study will compare clinical outcomes of immediate stent implantation with deferred stent implantation(4-10days after primary angiography) for patients presented with acute myocardial infarction due to left main coronary artery occlusion.
Read the detailed description
Primary percutaneous coronary intervention for patients presented with acute myocardial infarction caused by left main coronary artery occlusion is associated with significantly higher mortality and risks of major cardiac adverse events. Deferred stent implantation may improve prognosis of primary PCI through reducing distal embolization and no-reflow phenomenon. There is no randomized clinical trial focuses on the effect and outcome of deferred stent implantation on primary PCI for left main coronary artery occlusion in contrast with conventional strategy.
This prospective, multicenter, randomized trial is aimed to compare immediate stenting with deferred stenting for LM-AMI with 30 centers in China involved. We hope to determine whether deferred stenting is superior to conventional strategy for primary PCI of AMI caused by left main coronary artery occlusion in improving long-term clinical outcomes and cardiac function.
- Being tested
- Deferred stent implantation, Immediate stent implantation
- Keywords
- acute myocardial infarction, percutaneous coronary intervention, deferred stent implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deferred stent implantationDevice
Primary angiography and pretreatment including balloon dilatation and thrombus aspiration, second generation drug-eluting stents are implanted 4-10 days after restoration of blood flow in left main coronary artery in a secondary PCI.
Immediate stent implantationDevice
Primary angiography and pretreatment including balloon dilatation and thrombus aspiration, second generation drug-eluting stents are implanted immediately after restoration of blood flow in left main coronary artery in a secondary PCI.
| Study group | Role | What they receive |
|---|---|---|
| Deferred stent implantation | Experimental | Drug-eluting stents are implanted 4-10 days after primary angiography and restoration of blood flow in left main coroanry artery in a secondary PCI Receives: Device: Deferred stent implantation |
| Immediate stent implantation | Active comparator | Drug-eluting stents are implanted immediately after primary angiography and restoration of blood flow in left main coroanry artery Receives: Device: Immediate stent implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of cardiac death and recurrent myocardial infarction
Recorded in follow-up
Measured: 30 days after primary angiography
Secondary outcomes (3)
All cause death, cardiac death, recurrent myocardial infarction, target vessel revascularization
Recorded in follow-up
Measured: 30 days after primary angiography
Residual stenosis of left main coronary artery
Measured through angiography
Measured: Immediately after stent implantation and 12 months after primary angiography
Left ventricular ejection fraction
Measured through echocardiogram
Measured: 30 days and 12 months after primary angiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start1 Nov 2017
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junbo Ge, M.D., Principal investigator, Zhongshan Hospital,Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282773
- Sponsor's protocol ID
- B2017-104
- Acronym
- OPTIMAL
- Status last verified
- Nov 2017
- First submitted
- 10 Sep 2017
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gao Y, Zhang F, Li C, Dai Y, Yang J, Qu Y, Qian J, Ge J; OPTIMAL trial investigators. Optimal strategy of primary percutaneous coronary intervention for acute myocardial infarction due to unprotected left main coronary artery occlusion (OPTIMAL): study protocol for a randomised controlled trial. Trials. 2019 Mar 8;20(1):162. doi: 10.1186/s13063-019-3211-0.
PubMed 30850023
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Strategy of Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction Due to Unprotected Left Main Coronary Artery Occlusion
- ClinicalTrials.gov ID
- NCT03282773
- Acronym / sponsor ID
- OPTIMAL / B2017-104
- Keywords
- acute myocardial infarction, percutaneous coronary intervention, deferred stent implantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 14 Sep 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 study will compare clinical outcomes of immediate stent implantation with deferred stent implantation(4-10days after primary angiography) for patients presented with acute myocardial infarction due to left main coronary artery occlusion.
Detailed description
Primary percutaneous coronary intervention for patients presented with acute myocardial infarction caused by left main coronary artery occlusion is associated with significantly higher mortality and risks of major cardiac adverse events. Deferred stent implantation may improve prognosis of primary PCI through reducing distal embolization and no-reflow phenomenon. There is no randomized clinical trial focuses on the effect and outcome of deferred stent implantation on primary PCI for left main coronary artery occlusion in contrast with conventional strategy.
This prospective, multicenter, randomized trial is aimed to compare immediate stenting with deferred stenting for LM-AMI with 30 centers in China involved. We hope to determine whether deferred stenting is superior to conventional strategy for primary PCI of AMI caused by left main coronary artery occlusion in improving long-term clinical outcomes and cardiac function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deferred stent implantation | Experimental | Device: Deferred stent implantationDrug-eluting stents are implanted 4-10 days after primary angiography and restoration of blood flow in left main coroanry artery in a secondary PCI |
| Immediate stent implantation | Active comparator | Device: Immediate stent implantationDrug-eluting stents are implanted immediately after primary angiography and restoration of blood flow in left main coroanry artery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of acute myocardial infarction occured within 12 hours
- Left main coronary artery occlusion confirmed by angiography
- Left main coronary artery occlusion (TIMI flow 0,1 or 2) confirmed by primary angiography, TIMI flow grade 3 achieved after pretreatment of thrombus aspiration or balloon dilatation
Key exclusion criteria (7 listed)
- Life expectancy less than 1 years
- Cardiogenic shock
- Chronic kidney disease, stage 4 by KDOQI(GFR<30ml/min)
- Contraindications to aspirin or other anti-platelet drugs
- Allergy to contrast agent, rapamycin or paclitaxel
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 |
|---|---|---|
| Deferred stent implantationPrimary angiography and pretreatment including balloon dilatation and thrombus aspiration, second generation drug-eluting stents are implanted 4-10 days after restoration of blood flow in left main coronary artery in a secondary PCI. | Device | Deferred stent implantation |
| Immediate stent implantationPrimary angiography and pretreatment including balloon dilatation and thrombus aspiration, second generation drug-eluting stents are implanted immediately after restoration of blood flow in left main coronary artery in a secondary PCI. | Device | Immediate stent implantation |
Primary outcome
Composite of cardiac death and recurrent myocardial infarction
Time frame: 30 days after primary angiography
Recorded in follow-up
3 secondary outcomes
All cause death, cardiac death, recurrent myocardial infarction, target vessel revascularization
Time frame: 30 days after primary angiography
Residual stenosis of left main coronary artery
Time frame: Immediately after stent implantation and 12 months after primary angiography
Left ventricular ejection fraction
Time frame: 30 days and 12 months after primary angiography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
- Derived from this study: PubMed 30850023Gao Y, Zhang F, Li C, Dai Y, Yang J, Qu Y, Qian J, Ge J; OPTIMAL trial investigators. Optimal strategy of primary percutaneous coronary intervention for acute myocardial infarction due to unprotected left main coronary artery occlusion (OPTIMAL): study protocol for a randomised controlled trial. Trials. 2019 Mar 8;20(1):162. doi: 10.1186/s13063-019-3211-0.
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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.
Junbo Ge, M.D. principal investigator
Zhongshan Hospital,Shanghai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deferred stent implantation and Immediate stent implantation in people with Acute Myocardial Infarction and Percutaneous Coronary Intervention, run by Shanghai Zhongshan Hospital 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 3 inclusion and 7 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 21 Nov 2017. 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 Feng Zhang, M.D. (13917149007, zhang.feng@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of cardiac death and recurrent myocardial infarction (time frame: 30 days after primary angiography). 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 NCT03282773, which also lists 1 linked publication.
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 21 Nov 2017.