Coronary Artery DiseaseFISSTEMINCT04663932
Primary FIbrinolysis and Secondary STenting Versus immEdiate Stenting in ST-segment Elevation Myocardial Infarction
A study testing immediate stenting group(one-step strategy) and deferred stenting group (two-step strategy) in people with Coronary Artery Disease and Myocardial Ischemia, run by Harbin Medical University at 1 site in China.
Trial summary
This prospective, multicenter, randomized, controlled, open-label clinical study has a target enrollment of 240 subjects. It will explore whether STEMI patients transferred to a PCI center following thrombolytic therapy and expected to have stent implantation might benefit from an alternative treatment strategy and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease, Myocardial Ischemia, Acute Coronary Syndrome
- What is being tested?
- immediate stenting group(one-step strategy) and deferred stenting group (two-step strategy)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 22 Dec 2020to Mar 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatients who meet all of the following criteria can be included in the study:
- Age: 18-75 years old;
- A confirmed diagnosis of STEMI with symptom onset within 12 h;
- STEMI criteria:
- Patient has a history of chest pain/discomfort;
- ST elevation ≥ 0.1 mV in at least two contiguous leads of an ECG on admission (> 30 minutes; ≥ 0.2 mV required for V2 and V3 ) or the development of new left bundle branch block (LBBB);
- an increase in cardiac biomarkers (troponin, CK-MB) above the 99th percentile of the laboratory upper reference limit; 3. Time from FMC to wire crossing estimated to be > 120 min; 4. Has a target vessel with TIMI grade 3 flow shown as by CAG and ≥ 50% angiographic stenosis after thrombus aspiration; 5. Has culprit lesions identified as primary lesions; 6. Signed the written informed consent form.
Who cannot join
- Patients are not eligible for enrollment if they meet any of the following criteria:
- A contraindication to thrombolysis;
- An estimated survival time ≤ 12 months;
- Known heart failure of Killip class III or above, or mechanical complications such as heart rupture;
- Known to be participating in any other clinical trial;
- Pregnant or lactating women, or women experiencing their menstrual period;
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- Weight < 40 Kg or > 125 Kg;
- Known allergies to drugs that are required during the study such as contrast agents, antiplatelet drugs, and anticoagulants;
- A target vessel with TIMI grade 0-2 flow as revealed by the initial CAG;
- Having lesions located in the LMCA or root of the LAD, or with severe multiple vessel disease.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000
Muhua Cao, M.D., +86 15045643585, caomuhuayaoyao@163.com
About this study
Official title: Primary FIbrinolysis and Secondary STenting Versus immEdiate Stenting in ST-segment Elevation Myocardial Infarction (FISSTEMI)-- A Prospective Randomized Trial of Stent Implantation Strategy After Thrombolytic Therapy
This prospective, multicenter, randomized, controlled, open-label clinical study has a target enrollment of 240 subjects. It will explore whether STEMI patients transferred to a PCI center following thrombolytic therapy and expected to have stent implantation might benefit from an alternative treatment strategy and the use of new technologies designed to improve myocardial protection throughout the medical care process.
Read the detailed description
Eligible patients with STEMI who meet the Inclusion/Exclusion Criteria will receive thrombolytic therapy, and then be transferred to the PCI center for coronary angiography (CAG). Patients having a target vessel with TIMI grade 3 flow as shown by CAG, and and ≥ 50% angiographic stenosis after thrombus aspiration, will be randomized in a 1:1 ratio to either an immediate stenting group or a deferred stenting group. Patients assigned to the immediate stenting group will undergo appropriate stent implantation based on characteristics of the lesions. Patients assigned to the deferred stenting group will be sent back to the ward after PCI to receive standard anticoagulant and antiplatelet therapies, and the CAG will be repeated 5 to 7 days after initial intervention, followed by treatment with stent implantation.
All subjects will be recorded postoperative microcirculation perfusion and ST-segment drop of electrocardiogram and followed up by telephone or in the clinic at 1, 6, and 12 months after discharge from the hospital to obtain information including their general condition, chief complaints or discomforts, details of taking their oral medications, recent relevant test results, and to evaluate the primary endpoint, secondary endpoints.
- Conditions
- Coronary Artery Disease, Myocardial Ischemia, Acute Coronary Syndrome, Heart Diseases, Syndrome Heart Disease, Cardiovascular Diseases
- Being tested
- immediate stenting group(one-step strategy), deferred stenting group (two-step strategy)
- Keywords
- ST Elevation Myocardial Infarction, Microcirculatory dysfunction, Percutaneous coronary intervention, fibrinolysis
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia, Acute Coronary Syndrome, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate stenting group(one-step strategy)Procedure or surgery
Also called Immediate Angioplasty
Patients assigned to the immediate stenting group will undergo appropriate stent implantation based on characteristics of the lesions.
deferred stenting group (two-step strategy)Procedure or surgery
Also called Delayed angioplasty
Patients assigned to the deferred stenting group will be sent back to the ward after PCI to receive standard anticoagulant and antiplatelet therapies, and the CAG will be repeated 5 to 7 days after initial intervention, followed by treatment with stent implantation.
| Study group | Role | What they receive |
|---|---|---|
| immediate stenting group | Placebo comparator | Patients assigned to the immediate stenting group will undergo appropriate stent implantation based on characteristics of the lesions. Receives: Procedure: immediate stenting group(one-step strategy) |
| deferred stenting group | Experimental | Patients assigned to the deferred stenting group will be sent back to the ward after PCI to receive standard anticoagulant and antiplatelet therapies, and the CAG will be repeated 5 to 7 days after initial intervention, followed by treatment with stent implantation. Receives: Procedure: deferred stenting group (two-step strategy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete microvascular perfusion of subepicardial and myocardial tissues-TIMI flow grade 3
Complete microvascular perfusion of subepicardial and myocardial tissues: TIMI flow grade 3 and TMP grade 3 and complete ST resolution on an ECG at 60 minutes after study intervention (STR ≥ 70%).
For the immediate stenting group, the TIMI flow grade will be evaluated immediately after stent implantation. For the deferred stenting group, the TIMI flow grade will be evaluated after the first and second operations.
Measured: one minute after the end of the each procedure
Complete microvascular perfusion of subepicardial and myocardial tissues-TMP grade 3
Complete microvascular perfusion of subepicardial and myocardial tissues: TIMI flow grade 3 and TMP grade 3 and complete ST resolution on an ECG at 60 minutes after study intervention (STR ≥ 70%).
For the immediate stenting group, the TMP grade will be evaluated immediately after stent implantation. For the deferred stenting group, the TMP grade will be evaluated after the first and second operations.
Measured: one minute after the end of the each procedure
Complete microvascular perfusion of subepicardial and myocardial tissues-complete ST resolution on an ECG
Complete microvascular perfusion of subepicardial and myocardial tissues: TIMI flow grade 3 and TMP grade 3 and complete ST resolution on an ECG at 60 minutes after study intervention (STR ≥ 70%).
All patients will have an 18-lead ECG within 60 minutes after PCI.
Measured: within 60 minutes after PCI.
Secondary outcomes (8)
TIMI flow grade for infarct-related arteries
For the immediate stenting group, the TIMI flow grade will be evaluated immediately after stent implantation. For the deferred stenting group, the TIMI flow grade will be evaluated after the first and second operations.
Measured: one minute after the end of the each procedure
TIMI myocardial perfusion (TMP) grade for infarct-related arteries
For the immediate stenting group, the TMPG will be evaluated immediately after stent implantation. For the deferred stenting group, the TMPG will be evaluated after the first and second operations.
Measured: one minute after the end of the each procedure
Measurement of ST resolution on an ECG
All patients will have an 18-lead ECG within 60 minutes after PCI.
Measured: 60 minutes after PCI
TIMI myocardial blush grade (MBG) for infarct-related arteries
For the immediate stenting group, the MBG will be evaluated immediately after stent implantation. For the deferred stenting group, the MBG will be evaluated after the first and second operations.
Measured: one minute after the end of the each procedure
Corrected TIMI frame count (cTFC) for infarct-related arteries
For the immediate stenting group, the cTFC will be evaluated immediately after stent implantation. For the deferred stenting group, the cTFC will be evaluated after the first and second operations.
Measured: one minute after the end of the each procedure
TIMI myocardial perfusion frame count (TMPFC)
All subjects were required to calculate the preoperative and postoperative TMPFC (the delayed group was required to record the TMPFC before and after two operations respectively).
Measured: before and after each operation
Myocardial infarct size
The infarct area will be determined using semi-automatic contortion in the late short-axis enhanced image and will be expressed as a left ventricular mass percentage (%LV).
- Five to seven days after the first STEMI intervention (prior to discharge after delayed stent implantation), the myocardial infarct size will be recorded.
Measured: five to seven days after the last intervention (prior to discharge)
Myocardium salvage index (MSI)
- MSI refers to the ratio of rescue myocardium to AAR, which is a sensitive method to evaluate the effect of treatment.
- Five to seven days after the first STEMI intervention (prior to discharge after delayed stent implantation), the MSI will be recorded.
Measured: five to seven days after the last intervention (prior to discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start22 Dec 2020
- Primary completionMar 2022 (estimated)
- Study completionMar 2023 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible patients with STEMI who meet the Inclusion/Exclusion Criteria will receive thrombolytic therapy, and then be transferred to the PCI center for coronary angiography (CAG). Patients having a target vessel with TIMI grade 3 flow as shown by CAG, and and ≥ 50% angiographic stenosis after thrombus aspiration, will be randomized in a 1:1 ratio to either an immediate stenting group or a deferred stenting group. Patients assigned to the immediate stenting group will undergo appropriate stent implantation based on characteristics of the lesions. Patients assigned to the deferred stenting group will be sent back to the ward after PCI to receive standard anticoagulant and antiplatelet therapies, and the CAG will be repeated 5 to 7 days after initial intervention, followed by treatment with stent implantation.
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Tasly Pharmaceuticals, Inc.
- Responsible party
- Principal investigator, Yu Bo, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663932
- Sponsor's protocol ID
- FISSTEMI-phase I
- Acronym
- FISSTEMI
- Status last verified
- Mar 2022
- First submitted
- 25 Nov 2020
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary FIbrinolysis and Secondary STenting Versus immEdiate Stenting in ST-segment Elevation Myocardial Infarction (FISSTEMI)-- A Prospective Randomized Trial of Stent Implantation Strategy After Thrombolytic Therapy
- ClinicalTrials.gov ID
- NCT04663932
- Acronym / sponsor ID
- FISSTEMI / FISSTEMI-phase I
- Conditions
- Coronary Artery Disease, Myocardial Ischemia, Acute Coronary Syndrome, Heart Diseases, Syndrome Heart Disease, Cardiovascular Diseases
- Keywords
- ST Elevation Myocardial Infarction, Microcirculatory dysfunction, Percutaneous coronary intervention, fibrinolysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Collaborators
- Tasly Pharmaceuticals, Inc.
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 11 Dec 2020 (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 prospective, multicenter, randomized, controlled, open-label clinical study has a target enrollment of 240 subjects. It will explore whether STEMI patients transferred to a PCI center following thrombolytic therapy and expected to have stent implantation might benefit from an alternative treatment strategy and the use of new technologies designed to improve myocardial protection throughout the medical care process.
Detailed description
Eligible patients with STEMI who meet the Inclusion/Exclusion Criteria will receive thrombolytic therapy, and then be transferred to the PCI center for coronary angiography (CAG). Patients having a target vessel with TIMI grade 3 flow as shown by CAG, and and ≥ 50% angiographic stenosis after thrombus aspiration, will be randomized in a 1:1 ratio to either an immediate stenting group or a deferred stenting group. Patients assigned to the immediate stenting group will undergo appropriate stent implantation based on characteristics of the lesions. Patients assigned to the deferred stenting group will be sent back to the ward after PCI to receive standard anticoagulant and antiplatelet therapies, and the CAG will be repeated 5 to 7 days after initial intervention, followed by treatment with stent implantation.
All subjects will be recorded postoperative microcirculation perfusion and ST-segment drop of electrocardiogram and followed up by telephone or in the clinic at 1, 6, and 12 months after discharge from the hospital to obtain information including their general condition, chief complaints or discomforts, details of taking their oral medications, recent relevant test results, and to evaluate the primary endpoint, secondary endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible patients with STEMI who meet the Inclusion/Exclusion Criteria will receive thrombolytic therapy, and then be transferred to the PCI center for coronary angiography (CAG). Patients having a target vessel with TIMI grade 3 flow as shown by CAG, and and ≥ 50% angiographic stenosis after thrombus aspiration, will be randomized in a 1:1 ratio to either an immediate stenting group or a deferred stenting group. Patients assigned to the immediate stenting group will undergo appropriate stent implantation based on characteristics of the lesions. Patients assigned to the deferred stenting group will be sent back to the ward after PCI to receive standard anticoagulant and antiplatelet therapies, and the CAG will be repeated 5 to 7 days after initial intervention, followed by treatment with stent implantation.
| Arm | Type | Receives |
|---|---|---|
| immediate stenting group | Placebo comparator | Procedure: immediate stenting group(one-step strategy)Patients assigned to the immediate stenting group will undergo appropriate stent implantation based on characteristics of the lesions. |
| deferred stenting group | Experimental | Procedure: deferred stenting group (two-step strategy)Patients assigned to the deferred stenting group will be sent back to the ward after PCI to receive standard anticoagulant and antiplatelet therapies, and the CAG will be repeated 5 to 7 days after initial intervention, followed by treatment with stent implantation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Inpatients who meet all of the following criteria can be included in the study:
- Patient has a history of chest pain/discomfort;
- ST elevation ≥ 0.1 mV in at least two contiguous leads of an ECG on admission (> 30 minutes; ≥ 0.2 mV required for V2 and V3 ) or the development of new left bundle branch block (LBBB);
- an increase in cardiac biomarkers (troponin, CK-MB) above the 99th percentile of the laboratory upper reference limit; 3. Time from FMC to wire crossing estimated to be > 120 min; 4. Has a target vessel with TIMI grade 3 flow shown as by CAG and ≥ 50% angiographic stenosis after thrombus aspiration; 5. Has culprit lesions identified as primary lesions; 6. Signed the written informed consent form.
Key exclusion criteria (10 listed)
- Patients are not eligible for enrollment if they meet any of the following 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 |
|---|---|---|
| immediate stenting group(one-step strategy)Also: Immediate AngioplastyPatients assigned to the immediate stenting group will undergo appropriate stent implantation based on characteristics of the lesions. | Procedure or surgery | immediate stenting group |
| deferred stenting group (two-step strategy)Also: Delayed angioplastyPatients assigned to the deferred stenting group will be sent back to the ward after PCI to receive standard anticoagulant and antiplatelet therapies, and the CAG will be repeated 5 to 7 days after initial intervention, followed by treatment with stent implantation. | Procedure or surgery | deferred stenting group |
Primary outcome
Complete microvascular perfusion of subepicardial and myocardial tissues-TIMI flow grade 3
Time frame: one minute after the end of the each procedure
Complete microvascular perfusion of subepicardial and myocardial tissues: TIMI flow grade 3 and TMP grade 3 and complete ST resolution on an ECG at 60 minutes after study intervention (STR ≥ 70%). For the immediate stenting group, the TIMI flow grade will be evaluated immediately after stent implantation. For the deferred stenting group, the TIMI flow grade will be evaluated after the first and second operations.
Complete microvascular perfusion of subepicardial and myocardial tissues-TMP grade 3
Time frame: one minute after the end of the each procedure
Complete microvascular perfusion of subepicardial and myocardial tissues: TIMI flow grade 3 and TMP grade 3 and complete ST resolution on an ECG at 60 minutes after study intervention (STR ≥ 70%). For the immediate stenting group, the TMP grade will be evaluated immediately after stent implantation. For the deferred stenting group, the TMP grade will be evaluated after the first and second operations.
Complete microvascular perfusion of subepicardial and myocardial tissues-complete ST resolution on an ECG
Time frame: within 60 minutes after PCI.
Complete microvascular perfusion of subepicardial and myocardial tissues: TIMI flow grade 3 and TMP grade 3 and complete ST resolution on an ECG at 60 minutes after study intervention (STR ≥ 70%). All patients will have an 18-lead ECG within 60 minutes after PCI.
8 secondary outcomes
TIMI flow grade for infarct-related arteries
Time frame: one minute after the end of the each procedure
TIMI myocardial perfusion (TMP) grade for infarct-related arteries
Time frame: one minute after the end of the each procedure
Measurement of ST resolution on an ECG
Time frame: 60 minutes after PCI
TIMI myocardial blush grade (MBG) for infarct-related arteries
Time frame: one minute after the end of the each procedure
Corrected TIMI frame count (cTFC) for infarct-related arteries
Time frame: one minute after the end of the each procedure
TIMI myocardial perfusion frame count (TMPFC)
Time frame: before and after each operation
Myocardial infarct size
Time frame: five to seven days after the last intervention (prior to discharge)
Myocardium salvage index (MSI)
Time frame: five to seven days after the last intervention (prior to discharge)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immediate stenting group(one-step strategy) and deferred stenting group (two-step strategy) in people with Coronary Artery Disease and Myocardial Ischemia, run by Harbin Medical University 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 7 inclusion and 10 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 4 Apr 2022. 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. Some participants in this study may receive a placebo. 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 Muhua Cao, M.D. (+86 15045643585, caomuhuayaoyao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete microvascular perfusion of subepicardial and myocardial tissues-TIMI flow grade 3 (time frame: one minute after the end of the each procedure). The study lists 3 primary outcomes in all. 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 4 Apr 2022.