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Study on STEMI Reperfusion Strategy Based on the Characterization of Criminal Lesions Stability

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ClinicalTrials.gov Identifier: NCT03571269
Recruitment Status : Recruiting
First Posted : June 27, 2018
Last Update Posted : June 27, 2018
Sponsor:
Collaborator:
Second Hospital of Jilin University
Information provided by (Responsible Party):
Yu Bo, Harbin Medical University

Brief Summary:
A randomized controlled study of whether stent implantation in STEMI patients with ≤70% coronary stenosis was designed. A total of 240 STEMI patients with coronary artery diameter stenosis ≤ 70% were randomly assigned to either an OCT-guided group or an angiography-guided group. OCT guidance group: Stent implantation or drug therapy is determined based on the stability of the culprit lesions by the OCT. Angiographic guide group: According to the results of coronary angiography, stent implantation or drug treatment was determined. Comparing two groups the implantation rate, the incidence of HF within one year, the incidence of MACE, and the safety end point were used to investigate the effectiveness and safety of endovascular imaging in STEMI emergency intervention strategies.

Condition or disease Intervention/treatment
ST Elevation Myocardial Infarction Device: optical coherence tomography

Detailed Description:
This study is a prospective, randomized, controlled multicenter clinical study. Twenty hundred and forty AMI patients (according to all the inclusion criteria and did not meet any exclusion criteria) who were enrolled in the culprit who had a lesion stenosis ≤70% and who had TIMI blood flow grade 3 or residual stenosis ≤70% after thrombus aspiration and TIMI grade 3 were randomized Enter the OCT guidance group or the imaging guide group. For the OCT guidance group, if the OCT examination indicates that the patient's lesion features a plaque rupture, dissection, and severe calcification, the stent is implanted. If the lesion is characterized by plaque erosion, conservative treatment with drugs is used. For the contrast guide group, the surgeon judges the lesion according to the current treatment standard and decides whether to implant the stent. All subjects underwent outpatient follow-up in January after discharge from the hospital. Exercise stress test was needed to assess whether any recurrent ischemic events occurred. At 3, 6 and 9 months, telephone or outpatient visits were used. Follow-up visits were performed at the 12th month of follow-up and coronary angiography was performed. At each follow-up, general conditions, uncomfortable complaints, oral medications, recent related test results, and adverse events were required.

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Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study on STEMI Reperfusion Strategy Based on the Characterization of Criminal Lesions Stability
Actual Study Start Date : December 21, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Group/Cohort Intervention/treatment
OCT-guided group
OCT examination methods and precautions are the same as above. The operator judges the lesion according to the feature of culprit lesions from OCT. If a stent is implanted, postoperative OCT examination is performed. Based on the operator's experience, it is judged whether post-dilatation is necessary. Patients undergoing stent implantation should be treated with aspirin for at least 12 months.
Device: optical coherence tomography
optical coherence tomography was used to detect the pathological characteristics of culprit lesion. doctors decided whether or not PCI according to de OCT results.

angiography-guided group
CAG examination methods and precautions are the same as above. Patients undergoing conventional angiography and/or thrombus aspiration do not undergo OCT. The operator judges the lesion according to the current treatment standard and decides whether to implant the stent. If a stent is implanted, postoperative angiography (also required to meet the above body position requirements) is performed. Based on the operator's experience, it is judged whether post-dilatation is necessary. Patients undergoing stent implantation should be treated with aspirin for at least 12 months.



Primary Outcome Measures :
  1. Differences in the proportion of immediate stenting between the two groups; [ Time Frame: 1 year ]
    Differences in the proportion of immediate stenting between the two groups;

  2. the incidence of recurrent myocardial ischemic events (angina pectoris and recurrent myocardium, infarction) or sudden death within 1 month after discharge. [ Time Frame: 1 month ]
    the incidence of recurrent myocardial ischemic events (angina pectoris and recurrent myocardium, infarction) or sudden death within 1 month after discharge.


Secondary Outcome Measures :
  1. HF incidence [ Time Frame: 1 year ]
    HF incidence

  2. Stent patency and stenosis rate [ Time Frame: 1 year ]
    Stent patency and stenosis rate

  3. Incidence of cardiovascular and cerebrovascular events (death, AMI, stroke, revascularization, malignant arrhythmia, rehospitalization) within 1 year [ Time Frame: 1 year ]
    Incidence of cardiovascular and cerebrovascular events (death, AMI, stroke, revascularization, malignant arrhythmia, rehospitalization) within 1 year



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Inclusion Criteria:

  1. 18 years old ≤ age ≤ 80 years old;
  2. The diagnosis is STEMI, and the onset time is <12h;
  3. The lesions of the offender are in situ lesions;
  4. Sign written informed consent.

Exclusion Criteria:

  1. Hemodynamic instability;
  2. Coronary artery diameter stenosis ≤ 70% after thrombus aspiration catheter fails to pass or after thrombus aspiration;
  3. left main lesion;
  4. AMI is caused by surgery, trauma, gastrointestinal bleeding or PCI, or its complications;
  5. AMI occurs in patients who have been hospitalized for other reasons;
  6. The investigator judged that the patient had poor compliance and could not complete the study as required;
  7. The patient's life expectancy is ≤12 months;
  8. heart transplant patients;
  9. Definite diagnosis of patients with tumors
Criteria

Inclusion Criteria:

  1. 18 years old ≤ age ≤ 80 years old;
  2. The diagnosis is STEMI, and the onset time is <12h;
  3. The lesions of the offender are in situ lesions;
  4. Sign written informed consent.

Exclusion Criteria:

  1. Hemodynamic instability;
  2. Coronary artery diameter stenosis ≤ 70% after thrombus aspiration catheter fails to pass or after thrombus aspiration;
  3. left main lesion;
  4. AMI is caused by surgery, trauma, gastrointestinal bleeding or PCI, or its complications;
  5. AMI occurs in patients who have been hospitalized for other reasons;
  6. The investigator judged that the patient had poor compliance and could not complete the study as required;
  7. The patient's life expectancy is ≤12 months;
  8. heart transplant patients;
  9. Definite diagnosis of patients with tumors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03571269


Contacts
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Contact: Bo Yu, Doctor +86145186605180 yubodr@163.com

Locations
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China, Heilongjiang
The 2nd Affiliated Hospital of Harbin Medical University Recruiting
Harbin, Heilongjiang, China
Contact: Bo Yu, MD,PhD    +8645186605180    yubodr@163.com   
Sponsors and Collaborators
Harbin Medical University
Second Hospital of Jilin University

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Responsible Party: Yu Bo, Director, Harbin Medical University
ClinicalTrials.gov Identifier: NCT03571269     History of Changes
Other Study ID Numbers: 2016YFC1301103
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infarction
Myocardial Infarction
ST Elevation Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases