NCT04663932

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 25, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 11, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

December 22, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

April 4, 2022

Status Verified

March 1, 2022

Enrollment Period

1.2 years

First QC Date

November 25, 2020

Last Update Submit

March 31, 2022

Conditions

Coronary Artery DiseaseMyocardial IschemiaAcute Coronary SyndromeHeart DiseasesSyndrome Heart DiseaseCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesCoronary DiseaseVascular Diseases

Keywords

ST Elevation Myocardial InfarctionMicrocirculatory dysfunctionPercutaneous coronary interventionfibrinolysis

Outcome Measures

Primary Outcomes (3)

  • Complete microvascular perfusion of subepicardial and myocardial tissues-TIMI flow grade 3

    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.

    one minute after the end of the each procedure

  • Complete microvascular perfusion of subepicardial and myocardial tissues-TMP grade 3

    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.

    one minute after the end of the each procedure

  • Complete microvascular perfusion of subepicardial and myocardial tissues-complete ST resolution on an ECG

    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.

    within 60 minutes after PCI.

Secondary Outcomes (8)

  • TIMI flow grade for infarct-related arteries

    one minute after the end of the each procedure

  • TIMI myocardial perfusion (TMP) grade for infarct-related arteries

    one minute after the end of the each procedure

  • Measurement of ST resolution on an ECG

    60 minutes after PCI

  • TIMI myocardial blush grade (MBG) for infarct-related arteries

    one minute after the end of the each procedure

  • Corrected TIMI frame count (cTFC) for infarct-related arteries

    one minute after the end of the each procedure

  • +3 more secondary outcomes

Other Outcomes (6)

  • All-cause death

    1, 6, and 12 months

  • New or aggravated heart failure NYHA class IV

    1, 6, and 12 months

  • Non-fatal re-infarction or revascularization of any acute infarct-related artery

    1, 6, and 12 months

  • +3 more other outcomes

Study Arms (2)

immediate stenting group

PLACEBO COMPARATOR

Patients assigned to the immediate stenting group will undergo appropriate stent implantation based on characteristics of the lesions.

Procedure: immediate stenting group(one-step strategy)

deferred stenting group

EXPERIMENTAL

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.

Procedure: deferred stenting group (two-step strategy)

Interventions

immediate stenting group(one-step strategy)PROCEDURE

Patients assigned to the immediate stenting group will undergo appropriate stent implantation based on characteristics of the lesions.

Also known as: Immediate Angioplasty
immediate stenting group
deferred stenting group (two-step strategy)PROCEDURE

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.

Also known as: Delayed angioplasty
deferred stenting group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Inpatients who meet all of the following criteria can be included in the study:
  • Age: 18-75 years old;
  • A confirmed diagnosis of STEMI with symptom onset within 12 h;
  • STEMI criteria:
  • Patient has a history of chest pain/discomfort;
  • 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);
  • 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.

You may not qualify if:

  • Patients are not eligible for enrollment if they meet any of the following criteria:
  • A contraindication to thrombolysis;
  • An estimated survival time ≤ 12 months;
  • Known heart failure of Killip class III or above, or mechanical complications such as heart rupture;
  • Known to be participating in any other clinical trial;
  • Pregnant or lactating women, or women experiencing their menstrual period;
  • Weight \< 40 Kg or \> 125 Kg;
  • Known allergies to drugs that are required during the study such as contrast agents, antiplatelet drugs, and anticoagulants;
  • A target vessel with TIMI grade 0-2 flow as revealed by the initial CAG;
  • Having lesions located in the LMCA or root of the LAD, or with severe multiple vessel disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The 2nd Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150000, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial IschemiaAcute Coronary SyndromeHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesCoronary DiseaseVascular DiseasesST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Central Study Contacts

Muhua Cao, M.D.

CONTACT

+86 15045643585caomuhuayaoyao@163.com

Bo Yu, M.D.,FACC

CONTACT

+86 13804585601yubodr@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This study is a prospective, multicenter, randomized, controlled, open-label clinical study.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The Second Affiliated Hospital of Harbin Medical University

Study Record Dates

First Submitted

November 25, 2020

First Posted

December 11, 2020

Study Start

December 22, 2020

Primary Completion

March 1, 2022

Study Completion

March 1, 2023

Last Updated

April 4, 2022

Record last verified: 2022-03

Locations

CN(1)