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

Not Applicable

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

• Registration Number: NCT04663932
• Lead Sponsor: Harbin Medical University

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.

Study Timeline

• Study First Submitted: 2020-11-25
• Study First Submitted QC: 2020-12-05
• Study First Posted: 2020-12-11
• Study Start: 2020-12-22
• Status Verified: 2022-03
• Primary Completion: 2022-03
• Last Update Submitted: 2022-03-31
• Last Update Posted: 2022-04-04
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
deferred stenting group	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.
immediate stenting group	immediate stenting group(one-step strategy)	Patients assigned to the immediate stenting group will undergo appropriate stent implantation based on characteristics of the lesions.

Primary Outcome Measures

Name	Time	Method
Complete microvascular perfusion of subepicardial and myocardial tissues-TIMI flow grade 3	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-complete ST resolution on an ECG	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.
Complete microvascular perfusion of subepicardial and myocardial tissues-TMP grade 3	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.

Secondary Outcome Measures

Name	Time	Method
TIMI myocardial perfusion frame count (TMPFC)	before and after each operation	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).
TIMI myocardial perfusion (TMP) grade for infarct-related arteries	one minute after the end of the each procedure	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.
Corrected TIMI frame count (cTFC) for infarct-related arteries	one minute after the end of the each procedure	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.
Myocardium salvage index (MSI)	five to seven days after the last intervention (prior to discharge)	1. MSI refers to the ratio of rescue myocardium to AAR, which is a sensitive method to evaluate the effect of treatment.; 2. Five to seven days after the first STEMI intervention (prior to discharge after delayed stent implantation), the MSI will be recorded.
TIMI flow grade for infarct-related arteries	one minute after the end of the each procedure	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.
Measurement of ST resolution on an ECG	60 minutes after PCI	All patients will have an 18-lead ECG within 60 minutes after PCI.
Myocardial infarct size	five to seven days after the last intervention (prior to discharge)	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.
TIMI myocardial blush grade (MBG) for infarct-related arteries	one minute after the end of the each procedure	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.

Trial Locations

Locations (1)

The 2nd Affiliated Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China