Primary FIbrinolysis and Secondary STenting Versus immEdiate Stenting in ST-segment Elevation Myocardial Infarction (FISSTEMI)

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Artery Disease; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Acute Coronary Syndrome; Syndrome Heart Disease
• Intervention / Treatment: Procedure: immediate stenting group(one-step strategy); Procedure: deferred stenting group (two-step strategy)

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 Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Muhua Cao, M.D.; Phone Number: +86 15045643585; Email: caomuhuayaoyao@163.com
• Study Contact Backup: Name: Bo Yu, M.D.,FACC; Phone Number: +86 13804585601; Email: yubodr@163.com

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150000
      • Recruiting
      • The 2nd Affiliated Hospital of Harbin Medical University
      • Contact: Muhua Cao, M.D.; Phone Number: +86 15045643585; Email: caomuhuayaoyao@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Inpatients who meet all of the following criteria can be included in the study:

  1. Age: 18-75 years old;
  2. A confirmed diagnosis of STEMI with symptom onset within 12 h;

STEMI criteria:

1. Patient has a history of chest pain/discomfort;
2. 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);
3. 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:

  1. A contraindication to thrombolysis;
  2. An estimated survival time ≤ 12 months;
  3. Known heart failure of Killip class III or above, or mechanical complications such as heart rupture;
  4. Known to be participating in any other clinical trial;
  5. Pregnant or lactating women, or women experiencing their menstrual period;
  6. Weight < 40 Kg or > 125 Kg;
  7. Known allergies to drugs that are required during the study such as contrast agents, antiplatelet drugs, and anticoagulants;
  8. A target vessel with TIMI grade 0-2 flow as revealed by the initial CAG;
  9. Having lesions located in the LMCA or root of the LAD, or with severe multiple vessel disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: immediate stenting group; Patients assigned to the immediate stenting group will undergo appropriate stent implantation based on characteristics of the lesions.	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.; Other Names: Immediate Angioplasty
Experimental: deferred stenting group; 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.	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.; Other Names: Delayed angioplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	within 60 minutes after PCI.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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).	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). 2. Five to seven days after the first STEMI intervention (prior to discharge after delayed stent implantation), the myocardial infarct size will be recorded.	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.	five to seven days after the last intervention (prior to discharge)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause death	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.	1, 6, and 12 months
New or aggravated heart failure NYHA class IV	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.	1, 6, and 12 months
Non-fatal re-infarction or revascularization of any acute infarct-related artery	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.	1, 6, and 12 months
Cardiogenic shock (1, 6, and 12 months after postoperation)	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.	1, 6, and 12 months
Bleeding complications (classified as GUSTO)	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.	1, 6, and 12 months
Stroke	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.	1, 6, and 12 months

Collaborators and Investigators

• Sponsor: Harbin Medical University
• Collaborators: Tasly Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2020
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: November 25, 2020
• First Submitted That Met QC Criteria: December 5, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): April 4, 2022
• Last Update Submitted That Met QC Criteria: March 31, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Percutaneous coronary intervention; ST Elevation Myocardial Infarction; fibrinolysis; Microcirculatory dysfunction
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Disease; Myocardial Infarction; Infarction; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Cardiovascular Diseases; Syndrome; ST Elevation Myocardial Infarction; Vascular Diseases; Arterial Occlusive Diseases; Arteriosclerosis; Acute Coronary Syndrome
• Other Study ID Numbers: FISSTEMI-phase I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No