Clinical trial NCT03406819: Prevention of Coronary Slow Flow or No-Reflow During PPCI in Patients With Acute STEMI
Official title: Prevention of Coronary Slow Flow or No-Reflow During Primary Percutaneous Coronary Intervention in Patients With Acute ST-segment Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ST Segment Elevation Myocardial Infarction
Primary Percutaneous Coronary Intervention
Keywords: Prevention
Slow flow
No reflow
Nitroprusside
Tirofiban
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
Collaborators: name: Anyang Regional Hospital
name: Huaihe Hospital of Henan University
name: The First Affiliated Hospital of Henan University of Science and Technology
name: Yellow River Sanmenxia hospital
name: The Peoples' Hospital of Jiaozuo City
name: Jincheng People's Hospital
name: The second people's Hospital of Jiyuan
name: Kaifeng Central Hospital
name: Lushan People's Hospital
name: Nanyang Central Hospital
name: The Second People's Hospital of Pingdingshan
name: Shenma Medical Group General Hospital
name: Puyang People's Hospital
name: Puyang Oilfield General Hospital
name: The First People's Hospital of Shangqiu
name: Yanshi People's Hospital
name: The First People's Hospital of Xinmi
name: First Affiliated Hospital of Xinjiang Medical University
name: Xinyang Central Hospital
name: People's Hospital of Zhengzhou University
name: Zhengzhou First People's Hospital
name: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Zhengzhou Central Hospital
name: The 99th Central Hospital of the People's Liberation Army
name: Zhoukou Central Hospital
name: The First People's Hospital of Zhumadian
name: Zhumadian Central Hospital
First posted: 2018-01-23
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Coronary artery flow using thrombolysis in myocardial infarction (TIMI) flow grade after stent implantation
timeFrame: 1 minute after stent implantation
measure: Coronary artery flow using TIMI flow grade after balloon dilatation
timeFrame: 1 minute after balloon dilatation
measure: Coronary TIMI frame count after stent implantation
timeFrame: 1 minute after stent implantation
measure: Coronary TIMI frame count after balloon dilatation
timeFrame: 1 minute after balloon dilatation
measure: Slow flow / no-reflow phenomenon after stent implantation
timeFrame: 1 minute after stent implantation
measure: Slow flow / no-reflow phenomenon after balloon dilatation
timeFrame: 1 minute after balloon dilatation
measure: ECG ST-segment fall more than 50%
timeFrame: in 2 hours post-PCI
Secondary outcomes:
measure: Main adverse cardiovascular and cerebrovascular events (MACCE)
timeFrame: at 1 day post-PCI, at follow up of 1, 3, 6,12 months post-PCI
Other outcomes:
Locations:
city: Anyang
country: China
facility: Anyang District Hospital
state: Henan
city: Jiaozuo
country: China
facility: The 99th Central Hospital of the People's Liberation Army
state: Henan
city: Jiaozuo
country: China
facility: The People's Hospital of Jiaozuo
state: Henan
city: Jiyuan
country: China
facility: The second people's Hospital of Jiyuan
state: Henan
city: Kaifeng
country: China
facility: Huaihe Hospital of Henan University
state: Henan
city: Kaifeng
country: China
facility: Kaifeng Central Hospital
state: Henan
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
state: Henan
city: Lushan
country: China
facility: Lushan People's Hospital
state: Henan
city: Nanyang
country: China
facility: Nanyang City Center Hospital
state: Henan
city: Pingdingshan
country: China
facility: Pingmei Shenma Medical Group General Hospital
state: Henan
city: Pingdingshan
country: China
facility: The Second People's Hospital of Pingdingshan
state: Henan
city: Puyang
country: China
facility: Puyang Oilfield General Hospital
state: Henan
city: Puyang
country: China
facility: Puyang People's Hospital
state: Henan
city: Sanmenxia
country: China
facility: Yellow River Sanmenxia hospital
state: Henan
city: Shangqiu
country: China
facility: The First People's Hospital of Shangqiu
state: Henan
city: Xinxiang
country: China
facility: The First Affiliated Hospital of Xinxiang Medical University
state: Henan
city: Xinyang
country: China
facility: Xinyang Central Hospital
state: Henan
city: Yanshi
country: China
facility: Yanshi People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: Zhengzhou First People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: Zhengzhou Cardiovascular Hospital
state: Henan
city: Zhengzhou
country: China
facility: Zhengzhou Central Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Zhengzhou
country: China
facility: People's Hospital of Zhengzhou
state: Henan
city: Zhengzhou
country: China
facility: The First People's Hospital of Xinmi
state: Henan
city: Zhoukou
country: China
facility: Zhoukou Central Hospital
state: Henan
city: Zhumadian
country: China
facility: The First People's Hospital of Zhumadian
state: Henan
city: Zhumadian
country: China
facility: Zhumadian Central Hospital
state: Henan
city: Jincheng
country: China
facility: Jincheng People's Hospital
state: Shanxi
Study officials:
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Chunguang Qiu, Phd
role: PRINCIPAL_INVESTIGATOR
References: