Prevention of Coronary Slow Flow or No-Reflow During PPCI in Patients With Acute STEMI (NOSLOWFLOW-Ⅰ)

Prevention of Coronary Slow Flow or No-Reflow During Primary Percutaneous Coronary Intervention in Patients With Acute ST-segment Elevation Myocardial Infarction

Primary percutaneous coronary intervention (PPCI) is the gold standard of treatment of ST segment elevation myocardial infarction (STEMI).Slow flow / no-reflow phenomenon following PPCI in STEMI patients has been a serious and common complication that closely related to the incidence of major adverse cardiovascular events (MACE) and affected patients' prognosis. No reflow is a multi-factorial phenomenon. And its preventive and therapeutic effects are not satisfactory. This prospective randomized controlled study aimed to compare favorable effects of Nitroprusside versus Tirofiban on the prevention of slow flow / no-reflow phenomenon during PPCI.

Study Overview

• Status: Unknown
• Conditions: ST Segment Elevation Myocardial Infarction; Primary Percutaneous Coronary Intervention
• Intervention / Treatment: Drug: Nitroprusside Sodium; Drug: Tirofiban Hydrochloride; Drug: Heparinized saline

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan
    • Anyang, Henan, China, 455000
      • Recruiting
      • Anyang District Hospital
    • Jiaozuo, Henan, China, 454000
      • Recruiting
      • The 99th Central Hospital of the People's Liberation Army
    • Jiaozuo, Henan, China, 454002
      • Recruiting
      • The People's Hospital of Jiaozuo
    • Jiyuan, Henan, China, 454000
      • Recruiting
      • The second people's Hospital of Jiyuan
    • Kaifeng, Henan, China, 475000
      • Recruiting
      • Huaihe Hospital of Henan University
    • Kaifeng, Henan, China, 475000
      • Recruiting
      • Kaifeng Central Hospital
    • Luoyang, Henan, China, 471003
      • Recruiting
      • The First Affiliated Hospital of Henan University of Science and Technology
    • Lushan, Henan, China, 467300
      • Recruiting
      • Lushan People's Hospital
    • Nanyang, Henan, China, 473000
      • Recruiting
      • Nanyang City Center Hospital
    • Pingdingshan, Henan, China, 467000
      • Recruiting
      • Pingmei Shenma medical group general hospital
    • Pingdingshan, Henan, China, 467000
      • Recruiting
      • The Second People's Hospital of Pingdingshan
    • Puyang, Henan, China, 457000
      • Recruiting
      • Puyang Oilfield General Hospital
    • Puyang, Henan, China, 457099
      • Recruiting
      • Puyang People's Hospital
    • Sanmenxia, Henan, China, 472000
      • Recruiting
      • Yellow River Sanmenxia Hospital
    • Shangqiu, Henan, China, 476000
      • Recruiting
      • The First People's Hospital of Shangqiu
    • Xinxiang, Henan, China, 453100
      • Recruiting
      • The First Affiliated Hospital of Xinxiang Medical University
    • Xinyang, Henan, China, 464000
      • Recruiting
      • Xinyang Central Hospital
    • Yanshi, Henan, China, 471900
      • Recruiting
      • Yanshi People's Hospital
    • Zhengzhou, Henan, China, 450052
      • Recruiting
      • The First Affiliated Hospital of Zhengzhou University
      • Contact: Chunguang Qiu, Phd
    • Zhengzhou, Henan, China, 450007
      • Recruiting
      • Zhengzhou Central Hospital
    • Zhengzhou, Henan, China, 450004
      • Recruiting
      • Zhengzhou First People's Hospital
    • Zhengzhou, Henan, China, 450006
      • Recruiting
      • Zhengzhou Cardiovascular Hospital
    • Zhengzhou, Henan, China, 450053
      • Recruiting
      • People's Hospital of Zhengzhou
    • Zhengzhou, Henan, China, 452370
      • Recruiting
      • The First People'S Hospital of Xinmi
    • Zhoukou, Henan, China, 466000
      • Recruiting
      • Zhoukou Central Hospital
    • Zhumadian, Henan, China, 463000
      • Recruiting
      • The First People's Hospital of Zhumadian
    • Zhumadian, Henan, China, 463000
      • Recruiting
      • Zhumadian Central Hospital
  • Shanxi
    • Jincheng, Shanxi, China, 048026
      • Recruiting
      • Jincheng People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ischemic symptoms < 12h, or evidence of ongoing ischemia 12h after symptom onset
• Continued ischemic chest pain > 30min
• ST-segment elevation ≥ 0.1 millivolt in 2 or more contiguous leads on the 12-lead ECG or new left bundle branch block (LBBB)
• Detection of a rise of cardiac biomarker values with at least one value above the 99th percentile upper reference limit (URL)
• Primary coronary artery angiography was planned.

Exclusion Criteria:

• Emergency thrombolytic therapy was performed before primary coronary artery angiography
• Cardiogenic shock with no response to hypervolemic treatment or vasopressor
• Severe cardiomyopathy or valvular disease requiring intervention
• Coronary ectasia
• Severe heart failure
• Contraindication or allergy to antiplatelet drugs
• Contraindication or allergy to experimental drugs
• Unable to receive at least 1 year of dual antiplatelet therapy
• Active bleeding or extreme-risk for major bleeding
• Severe liver or renal failure
• Life expectancy < 1 year
• Unable or unwilling to provide informed consent
• Women of child bearing potential
• Under 18 years of age
• Hemoglobin < 90g/L
• Platelet count < 100×10^9/L
• Can not cooperate (with mental disorders or cognitive disorders)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nitroprusside group; After coronary target vessel blood flow recovery by thrombus aspiration or/and balloon angioplasty (diameter ≤ 2.0mm), intracoronary infusion of Nitroprusside Sodium via guide-catheter was performed. Then repeated administration of Nitroprusside Sodium was done prior to coronary stent implantation or post dilatation.	Drug: Nitroprusside Sodium; Intracoronary infusion 50~100μg each time (repeated); Other Names: Experimental-1 group
Experimental: Tirofiban group; After coronary target vessel blood flow recovery by thrombus aspiration or/and balloon angioplasty (diameter ≤ 2.0mm), intracoronary infusion of Tirofiban Hydrochloride via guide-catheter was performed.	Drug: Tirofiban Hydrochloride; Intracoronary infusion 10μg/kg for single time; Other Names: Experimental-2 group
Placebo Comparator: Control group; After coronary target vessel blood flow recovery by thrombus aspiration or/and balloon angioplasty (diameter ≤ 2.0mm), intracoronary infusion of heparinized saline via guide-catheter was performed.	Drug: Heparinized saline; Intracoronary infusion 2ml for single time; Other Names: Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coronary artery flow using thrombolysis in myocardial infarction (TIMI) flow grade after stent implantation	Grade 0, no myocardial blush or contrast density; grade 1, minimal myocardial blush or contrast density; grade 2, moderate myocardial blush or contrast density but less than that obtained during angiography of a contralateral or ipsilateral noninfarct-related coronary artery; grade 3, normal myocardial blush or contrast density comparable with that obtained during angiography of a contralateral or ipsilateral noninfarct-related coronary artery.	1 minute after stent implantation
Coronary artery flow using TIMI flow grade after balloon dilatation	Grade 0, no myocardial blush or contrast density; grade 1, minimal myocardial blush or contrast density; grade 2, moderate myocardial blush or contrast density but less than that obtained during angiography of a contralateral or ipsilateral noninfarct-related coronary artery; grade 3, normal myocardial blush or contrast density comparable with that obtained during angiography of a contralateral or ipsilateral noninfarct-related coronary artery.	1 minute after balloon dilatation
Coronary TIMI frame count after stent implantation	A continuous measurement assessing flow in the epicardial arteries.	1 minute after stent implantation
Coronary TIMI frame count after balloon dilatation	A continuous measurement assessing flow in the epicardial arteries.	1 minute after balloon dilatation
Slow flow / no-reflow phenomenon after stent implantation	Slow flow phenomenon means delayed progression or lack of contrast medium through the coronary tree.	1 minute after stent implantation
Slow flow / no-reflow phenomenon after balloon dilatation	Slow flow phenomenon means delayed progression or lack of contrast medium through the coronary tree.	1 minute after balloon dilatation
ECG ST-segment fall more than 50%	The extent of ST segment elevation was reduced by more than 50%	in 2 hours post-PCI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Main adverse cardiovascular and cerebrovascular events (MACCE)	Death, Cardiac death, Rehospitalization (Heart failure) , Non-fatal myocardial infarction, Target vessel myocardial infarction, Target lesion revascularization, Target vessel revascularization, Ischemic-driven revascularization, Stent thrombosis, Bleeding, Cerebrovascular events, etc.	at 1 day post-PCI, at follow up of 1, 3, 6,12 months post-PCI

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Zhengzhou University
• Collaborators: The First Affiliated Hospital of Henan University of Science and Technology; First Affiliated Hospital of Xinjiang Medical University; The First People's Hospital of Shangqiu; Puyang Oilfield General Hospital; Nanyang Central Hospital; Shenma Medical Group General Hospital; Xinyang Central Hospital; Huaihe Hospital of Henan University; Kaifeng Central Hospital; Zhengzhou Cardiovascular Hospital; Zhengzhou Central Hospital; People's Hospital of Zhengzhou University; Anyang Regional Hospital; Yellow River Sanmenxia hospital; The Peoples' Hospital of Jiaozuo City; Jincheng People's Hospital; The second people's Hospital of Jiyuan; Lushan People's Hospital; The Second People's Hospital of Pingdingshan; Puyang People's Hospital; Yanshi People's Hospital; The First People's Hospital of Xinmi; Zhengzhou First People's Hospital; The 99th Central Hospital of the People's Liberation Army; Zhoukou Central Hospital; The First People's Hospital of Zhumadian; Zhumadian Central Hospital
• Investigators: Principal Investigator: Chunguang Qiu, Phd, The First Affiliated Hospital of Zhengzhou University

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2018
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: January 8, 2018
• First Submitted That Met QC Criteria: January 19, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): January 23, 2018
• Last Update Submitted That Met QC Criteria: January 19, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Prevention; No reflow; Tirofiban; Slow flow; Nitroprusside
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Nitric Oxide Donors; Tirofiban; Nitroprusside
• Other Study ID Numbers: KS-2017-176

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No