Deferred or Immediate Stent Implantation Based on Microvascular Function in STEMI

ST Elevation Myocardial Infarction Clinical Trial

— SALVAGE  

Official title:

Deferred Versus Immediate Stent Implantation for Preventing Microvascular Dysfunction and Improving Clinical Outcomes in Patients With ST-Segment Elevation Myocardial Infarction (SALVAGE)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03581513
• Other study ID #: 2016YFC1301104
• Status: Terminated
• Phase: N/A
• Start date: December 20, 2017
• Est. completion date: August 31, 2021

Study information

• Verified date: June 2022
• Source: Harbin Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Timely percutaneous coronary intervention (PCI) with stenting implantation is the current standard treatment for patients with ST-segment elevation myocardial infarction (STEMI). However, stenting in thrombus-laden artery is associated with higher risk of embolization and no-or slow-reflow, leading to larger infarct size and poor prognosis. The SALVAGE study is a prospective, multicenter, randomized, controlled study aimed to optimize the therapeutic strategies (deferred vs. immediate stenting) to protect microvascular function and eventually improve clinical outcomes at 12-months in STEMI.

Description:

Methodology:

A multicenter, prospective, randomized, controlled clinical study enroll patients with ST-segment elevation myocardial infarction (STEMI) intended for PCI with stenting implantation. Eligible patients are randomly assigned to the immediate stenting group or delayed stenting group in a 1:1 ratio when residual stenosis >70% and TIMI grade 3 with angiography guidance.

The index of microcirculation resistance (IMR) is quantitative analysis by an invasive approach for evaluating post-infarct myocardial microcirculatory perfusion. IMR correlates with the infarct size of patients with acute myocardial infarction and predicts the improvement in left ventricular ejection fraction. Studies have shown that acute myocardial infarction patients with IMR >40 after primary PCI predict adverse long-term clinical outcomes with higher mortality and heart failure rehospitalization rates.

According to therapeutic strategies and microvascular function detected by IMR, participants are classified into four groups: immediate stenting with IMR ≥ 40, immediate stenting with IMR < 40, deferred stenting with IMR ≥ 40 and deferred stenting with IMR < 40. All randomized patients will be followed by phone call or clinical visit at 12 months.

Patient enrollment and procedure overview:

Patients aged from 18 to 80 with STEMI<12h in whom PCI is planned will be screened. Thrombectomy and balloon dilatation will be performed at the operator's discretion to restore an effective antegrade blood flow with TIMI flow grade 3. Patients with residual diameter stenosis >70% visually and TIMI blood flow grade 3 are eligible for including in the study. All patients must provide written informed consent and patients will be randomized to immediate stenting group or deferred stenting group in a 1:1 ratio. All participants in immediate stenting group will be treated with stent implantation immediately. Those assigned to the deferred arm will undergo stenting after an interval of 7±2 days. This interval will be bridged with anti-coagulant and anti-platelet therapy to reduce thrombus burden. All patients in both groups are required to take dual antiplatelet treatment while the application of low molecular weight heparin and glycoprotein IIb/IIIa inhibitor are determined by the operators. All participants are required to perform IMR pre-stenting and post-stenting to evaluate microcirculation function. All randomized patients will be followed up to 12 months to evaluate the prevalence of heart failure, all-cause mortality, recurrent infarction or targeted vessel revascularization.

Study follow-up:

Clinical follow-up:

Participants will be followed by phone calls or clinical visits by study coordinators at 1 month (+/-7 days), 3 months (+/-15 days), 6 months (+/-15 days), 9 months (+/-15 days) and 12 months (+/-30 days) after randomization. Major adverse cardiovascular events (MACEs) will be recorded throughout the study period until last patient has been followed for 12 months.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 629
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 18 years old = age = 80 years old;

• STEMI and the onset time <12h;

• The culprit lesions are de novo lesion;

• Sign written informed consent.

Exclusion Criteria:

• Patients are hemodynamically unstable;

• Infract-related artery diameter stenosis = 70%;

• Left main disease;

• AMI caused by surgery, trauma, gastrointestinal bleeding or PCI and complications;

• AMI occurs in patients who have been hospitalized for other reasons;

• The investigator judges that the patient has poor compliance and cannot complete the study as required;

• Life expectancy = 12 months;

• Heart transplant patients;

• Definite diagnosis of patients with tumors;

• Participate in other clinical studies (excluding other trials of this project) and haven't reach the primary endpoints.

Related Conditions & MeSH terms

• Infarction
• Microcirculatory Perfusion
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Procedure:
• Deferred or Immediate Stent Implantation
IMR can be used to measure the microcirculatory resistance of coronary artery. It is not clear whether the IMR value could determine the time of PCI for STEMI patients.

Locations

Country	Name	City	State
China	Beijing An Zhen Hospital, Capital Medical University	Beijing	Beijing
China	Daqing Longnan Hospital	Daqing	Heilongjiang
China	The 2nd Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	Jiamusi City Central Hospital	Jiamusi	Heilongjiang
China	The First Affiliated Hospital of Jiamusi University	Jiamusi	Heilongjiang
China	Mudanjiang Cardiovascular Hospital	Mudanjiang	Heilongjiang
China	Second hospital of hebei medical university	Shijiazhuang	Hebei
China	Shuangyashan Mining Hospital	Shuangyashan	Heilongjiang

Sponsors (8)

Lead Sponsor	Collaborator
Harbin Medical University	Beijing Anzhen Hospital, Daqing Longnan Hospital, First Affiliated Hospital of Jiamusi University, Jiamusi City Central Hospital, Mudanjiang cardiovascular hospital, Shuangyashan Mining Hospital, The Second Hospital of Hebei Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of heart failure, all-cause death, reinfarction and targeted vessel revascularization within 1 year of STEMI	MACE including the prevalence of heart failure, all-cause death, reinfarction and targeted vessel revascularization will be collected as the primary outcome.	1 year
Secondary	Peri-procedural myocardial reperfusion reinjury	Prevalence of in-hospital heart failure, all-cause death, re-myocardial infarction or targeted vessel revascularization.	through hospitalization, an average of 7 days
Secondary	Procedural success and clinical success	Culprit lesion stenosis<30% in the presence of TIMI 3 grade flow after PCI are regarded as procedural success.; Clinical success is determined as procedural success in the absence of in-hospital cardiac death, target vessel myocardial infarction and clinically-driven target lesion revascularization.	postprocedure and through hospitalization, an average of 7 days
Secondary	ECG ST-segment resolution at 90 minutes after primary PCI	We will compare the differences of the ST-segment resolution at 90 minutes among groups after primary PCI.	90 minutes postprocedure
Secondary	Peaks of CK, CK-MB, cTnI and area under CK curve	We will compare the peaks of CK, CK-MB, cTnI and area under CK curve while in hospital.	through hospitalization, an average of 7 days
Secondary	LVEF detected by echocardiographic indices at 7 days after stenting, 1 month and 12 months after discharge	LVEF will be detected by echocardiographic indices at 7 days after stenting, 1 month and 12 months after discharge	7 days, 1 month and 12months
Secondary	Contrast score index and myocardial blood flow detected by myocardial contrast echocardiography 7 days after stenting and 1 month after discharge	Contrast score index and myocardial blood flow detected by myocardial contrast echocardiography 7 days after stenting and 1 month after discharge	7 days and 1 month
Secondary	Hospitalization due to heart failure	Prevalence of hospitalization for heart failure will be compared among groups.	1 year