Clinical trial NCT03581513: Deferred or Immediate Stent Implantation Based on Microvascular Function in STEMI
Official title: Deferred Versus Immediate Stent Implantation for Preventing Microvascular Dysfunction and Improving Clinical Outcomes in Patients With ST-Segment Elevation Myocardial Infarction (SALVAGE)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Microcirculatory Perfusion
ST Elevation Myocardial Infarction
Keywords: deferred stent implantation
immediate stent implantation
microcirculation function
ST Elevation Myocardial Infarction
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
Collaborators: name: The Second Hospital of Hebei Medical University
name: Jiamusi City Central Hospital
name: Mudanjiang cardiovascular hospital
name: Shuangyashan Mining Hospital
name: First Affiliated Hospital of Jiamusi University
name: Daqing Longnan Hospital
name: Beijing Anzhen Hospital
First posted: 2018-07-10
Enrollment: 629
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of heart failure, all-cause death, reinfarction and targeted vessel revascularization within 1 year of STEMI
timeFrame: 1 year
Secondary outcomes:
measure: Peri-procedural myocardial reperfusion reinjury
timeFrame: through hospitalization, an average of 7 days
measure: Procedural success and clinical success
timeFrame: postprocedure and through hospitalization, an average of 7 days
measure: ECG ST-segment resolution at 90 minutes after primary PCI
timeFrame: 90 minutes postprocedure
measure: Peaks of CK, CK-MB, cTnI and area under CK curve
timeFrame: through hospitalization, an average of 7 days
measure: LVEF detected by echocardiographic indices at 7 days after stenting, 1 month and 12 months after discharge
timeFrame: 7 days, 1 month and 12months
measure: Contrast score index and myocardial blood flow detected by myocardial contrast echocardiography 7 days after stenting and 1 month after discharge
timeFrame: 7 days and 1 month
measure: Hospitalization due to heart failure
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing An Zhen Hospital, Capital Medical University
state: Beijing
city: Shijiazhuang
country: China
facility: Second hospital of hebei medical university
state: Hebei
city: Daqing
country: China
facility: Daqing Longnan Hospital
state: Heilongjiang
city: Harbin
country: China
facility: The 2nd Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Jiamusi
country: China
facility: Jiamusi City Central Hospital
state: Heilongjiang
city: Jiamusi
country: China
facility: The First Affiliated Hospital of Jiamusi University
state: Heilongjiang
city: Mudanjiang
country: China
facility: Mudanjiang Cardiovascular Hospital
state: Heilongjiang
city: Shuangyashan
country: China
facility: Shuangyashan Mining Hospital
state: Heilongjiang
Study officials:
affiliation: The Second Affiliated Hospital of Harbin Medical University
name: Bo Yu
role: STUDY_CHAIR
affiliation: The Second Hospital of Hebei Medical University
name: Xinshun Gu
role: PRINCIPAL_INVESTIGATOR
affiliation: Daqing Longnan Hospital
name: Lixin Lu
role: PRINCIPAL_INVESTIGATOR
affiliation: Jiamusi City Central Hospital
name: Zhiyuan Weng
role: PRINCIPAL_INVESTIGATOR
affiliation: Mudanjiang cardiovascular hospital
name: Kai Liu
role: PRINCIPAL_INVESTIGATOR
affiliation: Shuangyashan Mining Hospital
name: Hui Li
role: PRINCIPAL_INVESTIGATOR
affiliation: the first affiliated hospital of Jiamusi university
name: Shan Gao
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing An Zhen Hospital, Capital Medical University
name: ChunMei Wang
role: PRINCIPAL_INVESTIGATOR
References: