Back to resultsPrimary FIbrinolysis and Secondary STenting Versus immEdiate Stenting in ST-segment Elevation Myocardial Infarction (FISSTEMI)
Primary Purpose
Coronary Artery Disease, Myocardial Ischemia, Acute Coronary Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
immediate stenting group(one-step strategy)
deferred stenting group (two-step strategy)
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring ST Elevation Myocardial Infarction, Microcirculatory dysfunction, Percutaneous coronary intervention, fibrinolysis
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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;
- 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.
Sites / Locations
- The 2nd Affiliated Hospital of Harbin Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
immediate stenting group
deferred stenting group
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
Measurement of ST resolution on an ECG
All patients will have an 18-lead ECG within 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.
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.
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).
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).
2. Five to seven days after the first STEMI intervention (prior to discharge after delayed stent implantation), the myocardial infarct size will be recorded.
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.
Full Information
NCT ID
NCT04663932
First Posted
November 25, 2020
Last Updated
March 31, 2022
Sponsor
Harbin Medical University
Collaborators
Tasly Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04663932
Brief Title
Primary FIbrinolysis and Secondary STenting Versus immEdiate Stenting in ST-segment Elevation Myocardial Infarction
Acronym
FISSTEMI
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 22, 2020 (Actual)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harbin Medical University
Collaborators
Tasly Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Myocardial Ischemia, Acute Coronary Syndrome, Heart Diseases, Syndrome Heart Disease, Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Coronary Disease, Vascular Diseases
Keywords
ST Elevation Myocardial Infarction, Microcirculatory dysfunction, Percutaneous coronary intervention, fibrinolysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking Description
This study is a prospective, multicenter, randomized, controlled, open-label clinical study.
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
immediate stenting group
Arm Type
Placebo Comparator
Arm Description
Patients assigned to the immediate stenting group will undergo appropriate stent implantation based on characteristics of the lesions.
Arm Title
deferred stenting group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
immediate stenting group(one-step strategy)
Other Intervention Name(s)
Immediate Angioplasty
Intervention Description
Patients assigned to the immediate stenting group will undergo appropriate stent implantation based on characteristics of the lesions.
Intervention Type
Procedure
Intervention Name(s)
deferred stenting group (two-step strategy)
Other Intervention Name(s)
Delayed angioplasty
Intervention Description
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.
Primary Outcome Measure Information:
Title
Complete microvascular perfusion of subepicardial and myocardial tissues-TIMI flow grade 3
Description
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.
Time Frame
one minute after the end of the each procedure
Title
Complete microvascular perfusion of subepicardial and myocardial tissues-TMP grade 3
Description
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.
Time Frame
one minute after the end of the each procedure
Title
Complete microvascular perfusion of subepicardial and myocardial tissues-complete ST resolution on an ECG
Description
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.
Time Frame
within 60 minutes after PCI.
Secondary Outcome Measure Information:
Title
TIMI flow grade for infarct-related arteries
Description
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.
Time Frame
one minute after the end of the each procedure
Title
TIMI myocardial perfusion (TMP) grade for infarct-related arteries
Description
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.
Time Frame
one minute after the end of the each procedure
Title
Measurement of ST resolution on an ECG
Description
All patients will have an 18-lead ECG within 60 minutes after PCI.
Time Frame
60 minutes after PCI
Title
TIMI myocardial blush grade (MBG) for infarct-related arteries
Description
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.
Time Frame
one minute after the end of the each procedure
Title
Corrected TIMI frame count (cTFC) for infarct-related arteries
Description
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.
Time Frame
one minute after the end of the each procedure
Title
TIMI myocardial perfusion frame count (TMPFC)
Description
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).
Time Frame
before and after each operation
Title
Myocardial infarct size
Description
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).
2. Five to seven days after the first STEMI intervention (prior to discharge after delayed stent implantation), the myocardial infarct size will be recorded.
Time Frame
five to seven days after the last intervention (prior to discharge)
Title
Myocardium salvage index (MSI)
Description
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.
Time Frame
five to seven days after the last intervention (prior to discharge)
Other Pre-specified Outcome Measures:
Title
All-cause death
Description
All deaths will be considered to be cardiac deaths unless a clear non-cardiac cause is identified.
Patients will be followed up by telephone or in the clinic at 1, 6, and 12 months after discharge from the hospital to obtain information about all-cause death.
Time Frame
1, 6, and 12 months
Title
New or aggravated heart failure NYHA class IV
Description
Patients with cardiac disease that makes them unable to perform any physical activity without discomfort. Symptoms of heart failure may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Patients will be followed up by telephone or in the clinic at 1, 6, and 12 months after discharge from the hospital to obtain information about new or aggravated heart failure NYHA class IV.
Time Frame
1, 6, and 12 months
Title
Non-fatal re-infarction or revascularization of any acute infarct-related artery
Description
Myocardial infarction related to restenosis: angiographic restenosis ≥ 50% (complex lesions not found) after one stent implantation or balloon angioplasty procedure, accompanied by an elevation and/or decrease of cTn values in the absence of another occlusion.
Patients will be followed up by telephone or in the clinic at 1, 6, and 12 months after discharge from the hospital to obtain information about non-fatal re-infarction or revascularization of any acute infarct-related artery.
Time Frame
1, 6, and 12 months
Title
Cardiogenic shock (1, 6, and 12 months after postoperation)
Description
Cardiogenic shock: systolic blood pressure < 90 mmHg, urine volume < 20 mL/h, clammy skin, cyanosis, tachypnea, and a pulse rate > 100 bpm.
Patients will be followed up by telephone or in the clinic at 1, 6, and 12 months after discharge from the hospital to obtain information about cardiogenic shock.
Time Frame
1, 6, and 12 months
Title
Bleeding complications (classified as GUSTO)
Description
Severe or life-threatening: intracerebral hemorrhage or bleeding that results in substantial hemodynamic compromise requiring treatment;
Moderate: bleeding that requires blood transfusion but does not result in hemodynamic compromise;
Mild: bleeding that does not meet above criteria.
Patients will be followed up by telephone or in the clinic at 1, 6, and 12 months after discharge from the hospital to obtain information about bleeding complications.
Time Frame
1, 6, and 12 months
Title
Stroke
Description
Stroke is defined as a sudden onset of focal neurological deficits due to cerebrovascular lesions, which lasts > 24 hours. Stroke is caused by ischemic or hemorrhagic cerebrovascular disorders.
Patients will be followed up by telephone or in the clinic at 1, 6, and 12 months after discharge from the hospital to obtain information about stroke.
Time Frame
1, 6, and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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;
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhua Cao, M.D.
Phone
+86 15045643585
Email
caomuhuayaoyao@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bo Yu, M.D.,FACC
Phone
+86 13804585601
Email
yubodr@163.com
Facility Information:
Facility Name
The 2nd Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhua Cao, M.D.
Phone
+86 15045643585
Email
caomuhuayaoyao@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Primary FIbrinolysis and Secondary STenting Versus immEdiate Stenting in ST-segment Elevation Myocardial Infarction
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