NCT03581513

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
629

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 10, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

July 1, 2022

Status Verified

June 1, 2022

Enrollment Period

3.7 years

First QC Date

June 15, 2018

Last Update Submit

June 28, 2022

Conditions

Microcirculatory PerfusionST Elevation Myocardial Infarction

Keywords

deferred stent implantationimmediate stent implantationmicrocirculation functionST Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Peri-procedural myocardial reperfusion reinjury

    through hospitalization, an average of 7 days

  • Procedural success and clinical success

    postprocedure and through hospitalization, an average of 7 days

  • ECG ST-segment resolution at 90 minutes after primary PCI

    90 minutes postprocedure

  • Peaks of CK, CK-MB, cTnI and area under CK curve

    through hospitalization, an average of 7 days

  • LVEF detected by echocardiographic indices at 7 days after stenting, 1 month and 12 months after discharge

    7 days, 1 month and 12months

  • +2 more secondary outcomes

Study Arms (4)

IMR<40 and defer PCI

EXPERIMENTAL

Patients whose IMR\<40 undergo stent implantation after an interval of 7±2 days.

Procedure: Deferred or Immediate Stent Implantation

IMR<40 and immediately PCI

ACTIVE COMPARATOR

Patients whose IMR\<40 undergo immediately stent implantation.

Procedure: Deferred or Immediate Stent Implantation

IMR≥40 and defer PCI

EXPERIMENTAL

Patients whose IMR≥40 undergo stent implantation after an interval of 7±2 days.

Procedure: Deferred or Immediate Stent Implantation

IMR≥40 and immediately PCI

ACTIVE COMPARATOR

Patients whose IMR≥40 undergo immediately stent implantation.

Procedure: Deferred or Immediate Stent Implantation

Interventions

Deferred or Immediate Stent ImplantationPROCEDURE

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.

IMR<40 and defer PCIIMR<40 and immediately PCIIMR≥40 and defer PCIIMR≥40 and immediately PCI

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old ≤ age ≤ 80 years old;
  • STEMI and the onset time \<12h;
  • The culprit lesions are de novo lesion;
  • Sign written informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Beijing An Zhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

Location

Second hospital of hebei medical university

Shijiazhuang, Hebei, China

Location

Daqing Longnan Hospital

Daqing, Heilongjiang, China

Location

The 2nd Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Location

Jiamusi City Central Hospital

Jiamusi, Heilongjiang, China

Location

The First Affiliated Hospital of Jiamusi University

Jiamusi, Heilongjiang, China

Location

Mudanjiang Cardiovascular Hospital

Mudanjiang, Heilongjiang, China

Location

Shuangyashan Mining Hospital

Shuangyashan, Heilongjiang, China

Location

Related Publications (1)

  • Feng X, Xu Y, Zeng M, Qin Y, Weng Z, Sun Y, Gao Z, He L, Zhao C, Wang N, Zhang D, Wang C, Wang Y, Li L, Fang C, Dai J, Jia H, Yu B. Optical Coherence Tomography Assessment of Coronary Lesions Associated With Microvascular Dysfunction in ST-Segment Elevation Myocardial Infarction. Circ J. 2023 Oct 25;87(11):1625-1632. doi: 10.1253/circj.CJ-23-0200. Epub 2023 Sep 6.

    PMID: 37407487DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Bo Yu

    The Second Affiliated Hospital of Harbin Medical University

    STUDY CHAIR

  • Xinshun Gu

    The Second Hospital of Hebei Medical University

    PRINCIPAL INVESTIGATOR

  • Lixin Lu

    Daqing Longnan Hospital

    PRINCIPAL INVESTIGATOR

  • Zhiyuan Weng

    Jiamusi City Central Hospital

    PRINCIPAL INVESTIGATOR

  • Kai Liu

    Mudanjiang cardiovascular hospital

    PRINCIPAL INVESTIGATOR

  • Hui Li

    Shuangyashan Mining Hospital

    PRINCIPAL INVESTIGATOR

  • Shan Gao

    First Affiliated Hospital of Jiamusi University

    PRINCIPAL INVESTIGATOR

  • ChunMei Wang

    Beijing An Zhen Hospital, Capital Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

June 15, 2018

First Posted

July 10, 2018

Study Start

December 20, 2017

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

July 1, 2022

Record last verified: 2022-06

Locations

CN(8)