Microcirculatory PerfusionSALVAGENCT03581513
Deferred or Immediate Stent Implantation Based on Microvascular Function in STEMI
A study testing Deferred or Immediate Stent Implantation in people with Microcirculatory Perfusion and ST Elevation Myocardial Infarction, run by Harbin Medical University at 8 sites in China.
Trial summary
Timely percutaneous coronary intervention (PCI) with stenting implantation is the current standard treatment for patients with ST-segment elevation myocardial infarction (STEMI). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Microcirculatory Perfusion, ST Elevation Myocardial Infarction
- What is being tested?
- Deferred or Immediate Stent Implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 629 participants
- Where
- 8 sitesChina
- Study dates
- 20 Dec 2017to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old ≤ age ≤ 80 years old;
- STEMI and the onset time <12h;
- The culprit lesions are de novo lesion;
- Sign written informed consent.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Beijing An Zhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
Daqing Longnan Hospital
Daqing, Heilongjiang
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Jiamusi City Central Hospital
Jiamusi, Heilongjiang
The First Affiliated Hospital of Jiamusi University
Jiamusi, Heilongjiang
Mudanjiang Cardiovascular Hospital
Mudanjiang, Heilongjiang
Second hospital of hebei medical university
Shijiazhuang, Hebei
Shuangyashan Mining Hospital
Shuangyashan, Heilongjiang
About this study
Official title: Deferred Versus Immediate Stent Implantation for Preventing Microvascular Dysfunction and Improving Clinical Outcomes in Patients With ST-Segment Elevation Myocardial Infarction (SALVAGE)
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.
Read the 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.
- Being tested
- Deferred or Immediate Stent Implantation
- Keywords
- deferred stent implantation, immediate stent implantation, microcirculation function, ST Elevation Myocardial Infarction
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deferred or Immediate Stent ImplantationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| IMR<40 and defer PCI | Experimental | Patients whose IMR<40 undergo stent implantation after an interval of 7±2 days. Receives: Procedure: Deferred or Immediate Stent Implantation |
| IMR<40 and immediately PCI | Active comparator | Patients whose IMR<40 undergo immediately stent implantation. Receives: 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. Receives: Procedure: Deferred or Immediate Stent Implantation |
| IMR≥40 and immediately PCI | Active comparator | Patients whose IMR≥40 undergo immediately stent implantation. Receives: Procedure: Deferred or Immediate Stent Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (7)
Peri-procedural myocardial reperfusion reinjury
Prevalence of in-hospital heart failure, all-cause death, re-myocardial infarction or targeted vessel revascularization.
Measured: through hospitalization, an average of 7 days
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.
Measured: postprocedure and through hospitalization, an average of 7 days
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.
Measured: 90 minutes postprocedure
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.
Measured: through hospitalization, an average of 7 days
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
Measured: 7 days, 1 month and 12months
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
Measured: 7 days and 1 month
Hospitalization due to heart failure
Prevalence of hospitalization for heart failure will be compared among groups.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start20 Dec 2017
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Why it stopped: DSMB halted the study due to safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Microcirculatory PerfusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 629 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Hospital of Hebei Medical University, Jiamusi City Central Hospital, Mudanjiang cardiovascular hospital, Shuangyashan Mining Hospital, First Affiliated Hospital of Jiamusi University, Daqing Longnan Hospital, Beijing Anzhen Hospital
- Responsible party
- Principal investigator, Yu Bo, Harbin Medical University
- Investigators
- Bo Yu, Study chair, The Second Affiliated Hospital of Harbin Medical UniversityXinshun Gu, Principal investigator, The Second Hospital of Hebei Medical UniversityLixin Lu, Principal investigator, Daqing Longnan HospitalZhiyuan Weng, Principal investigator, Jiamusi City Central HospitalKai Liu, Principal investigator, Mudanjiang cardiovascular hospitalHui Li, Principal investigator, Shuangyashan Mining HospitalShan Gao, Principal investigator, First Affiliated Hospital of Jiamusi UniversityChunMei Wang, Principal investigator, Beijing An Zhen Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581513
- Sponsor's protocol ID
- 2016YFC1301104
- Acronym
- SALVAGE
- Status last verified
- Jun 2022
- First submitted
- 15 Jun 2018
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37407487
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deferred Versus Immediate Stent Implantation for Preventing Microvascular Dysfunction and Improving Clinical Outcomes in Patients With ST-Segment Elevation Myocardial Infarction (SALVAGE)
- ClinicalTrials.gov ID
- NCT03581513
- Acronym / sponsor ID
- SALVAGE / 2016YFC1301104
- Keywords
- deferred stent implantation, immediate stent implantation, microcirculation function, ST Elevation Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DSMB halted the study due to safety concerns.
- Enrolment
- 629 participants (actual)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Collaborators
- The Second Hospital of Hebei Medical University, Jiamusi City Central Hospital, Mudanjiang cardiovascular hospital, Shuangyashan Mining Hospital, First Affiliated Hospital of Jiamusi University, Daqing Longnan Hospital, Beijing Anzhen Hospital
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 10 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IMR<40 and defer PCI | Experimental | Procedure: Deferred or Immediate Stent ImplantationPatients whose IMR<40 undergo stent implantation after an interval of 7±2 days. |
| IMR<40 and immediately PCI | Active comparator | Procedure: Deferred or Immediate Stent ImplantationPatients whose IMR<40 undergo immediately stent implantation. |
| IMR≥40 and defer PCI | Experimental | Procedure: Deferred or Immediate Stent ImplantationPatients whose IMR≥40 undergo stent implantation after an interval of 7±2 days. |
| IMR≥40 and immediately PCI | Active comparator | Procedure: Deferred or Immediate Stent ImplantationPatients whose IMR≥40 undergo immediately stent implantation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years old ≤ age ≤ 80 years old;
- STEMI and the onset time <12h;
- The culprit lesions are de novo lesion;
- Sign written informed consent.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deferred or Immediate Stent ImplantationIMR 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. | Procedure or surgery | IMR<40 and defer PCI, IMR<40 and immediately PCI, IMR≥40 and defer PCI, IMR≥40 and immediately PCI |
Primary outcome
Prevalence of heart failure, all-cause death, reinfarction and targeted vessel revascularization within 1 year of STEMI
Time frame: 1 year
MACE including the prevalence of heart failure, all-cause death, reinfarction and targeted vessel revascularization will be collected as the primary outcome.
7 secondary outcomes
Peri-procedural myocardial reperfusion reinjury
Time frame: through hospitalization, an average of 7 days
Procedural success and clinical success
Time frame: postprocedure and through hospitalization, an average of 7 days
ECG ST-segment resolution at 90 minutes after primary PCI
Time frame: 90 minutes postprocedure
Peaks of CK, CK-MB, cTnI and area under CK curve
Time frame: through hospitalization, an average of 7 days
LVEF detected by echocardiographic indices at 7 days after stenting, 1 month and 12 months after discharge
Time frame: 7 days, 1 month and 12months
Contrast score index and myocardial blood flow detected by myocardial contrast echocardiography 7 days after stenting and 1 month after discharge
Time frame: 7 days and 1 month
Hospitalization due to heart failure
Time frame: 1 year
Results and safety
The study was stopped early (reason given: DSMB halted the study due to safety concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
- Derived from this study: PubMed 37407487Feng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Yu study chair
The Second Affiliated Hospital of Harbin Medical University
Xinshun Gu principal investigator
The Second Hospital of Hebei Medical University
Lixin Lu principal investigator
Daqing Longnan Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deferred or Immediate Stent Implantation in people with Microcirculatory Perfusion and ST Elevation Myocardial Infarction, run by Harbin Medical University at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: DSMB halted the study due to safety concerns.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of heart failure, all-cause death, reinfarction and targeted vessel revascularization within 1 year of STEMI (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03581513, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2022.