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

NCT03406819 | Unknown DMC

• 1 other identifier: KS-2017-176
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 28

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.

Conditions

ST Segment Elevation Myocardial Infarction; Primary Percutaneous Coronary Intervention

Keywords

Prevention; Slow flow; No reflow; Nitroprusside; Tirofiban

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (1)

• Main adverse cardiovascular and cerebrovascular events (MACCE)

  at 1 day post-PCI, at follow up of 1, 3, 6,12 months post-PCI

Study Arms (3)

Nitroprusside group

EXPERIMENTAL

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

Tirofiban group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Interventions

Nitroprusside Sodium DRUG

Intracoronary infusion 50\~100μg each time (repeated)

Also known as: Experimental-1 group

Nitroprusside group

Tirofiban Hydrochloride DRUG

Intracoronary infusion 10μg/kg for single time

Also known as: Experimental-2 group

Tirofiban group

Heparinized saline DRUG

Intracoronary infusion 2ml for single time

Also known as: Control group

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead
• Anyang Regional Hospital: collaborator
• Huaihe Hospital of Henan University: collaborator
• The First Affiliated Hospital of Henan University of Science and Technology: collaborator
• Yellow River Sanmenxia hospital: collaborator
• The Peoples' Hospital of Jiaozuo City: collaborator
• Jincheng People's Hospital: collaborator
• The second people's Hospital of Jiyuan: collaborator
• Kaifeng Central Hospital: collaborator
• Lushan People's Hospital: collaborator
• Nanyang Central Hospital: collaborator
• The Second People's Hospital of Pingdingshan: collaborator
• Shenma Medical Group General Hospital: collaborator
• Puyang People's Hospital: collaborator
• Puyang Oilfield General Hospital: collaborator
• The First People's Hospital of Shangqiu: collaborator
• Yanshi People's Hospital: collaborator
• The First People's Hospital of Xinmi: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator
• Xinyang Central Hospital: collaborator
• People's Hospital of Zhengzhou University: collaborator
• Zhengzhou First People's Hospital: collaborator
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator
• Zhengzhou Central Hospital: collaborator
• The 99th Central Hospital of the People's Liberation Army: collaborator
• Zhoukou Central Hospital: collaborator
• The First People's Hospital of Zhumadian: collaborator
• Zhumadian Central Hospital: collaborator

Study Sites (28)

Anyang District Hospital

Anyang, Henan, 455000, China

RECRUITING

The 99th Central Hospital of the People's Liberation Army

Jiaozuo, Henan, 454000, China

RECRUITING

The People's Hospital of Jiaozuo

Jiaozuo, Henan, 454002, China

RECRUITING

The second people's Hospital of Jiyuan

Jiyuan, Henan, 454000, China

RECRUITING

Huaihe Hospital of Henan University

Kaifeng, Henan, 475000, China

RECRUITING

Kaifeng Central Hospital

Kaifeng, Henan, 475000, China

RECRUITING

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 471003, China

RECRUITING

Lushan People's Hospital

Lushan, Henan, 467300, China

RECRUITING

Nanyang City Center Hospital

Nanyang, Henan, 473000, China

RECRUITING

Pingmei Shenma Medical Group General Hospital

Pingdingshan, Henan, 467000, China

RECRUITING

The Second People's Hospital of Pingdingshan

Pingdingshan, Henan, 467000, China

RECRUITING

Puyang Oilfield General Hospital

Puyang, Henan, 457000, China

RECRUITING

Puyang People's Hospital

Puyang, Henan, 457099, China

RECRUITING

Yellow River Sanmenxia hospital

Sanmenxia, Henan, 472000, China

RECRUITING

The First People's Hospital of Shangqiu

Shangqiu, Henan, 476000, China

RECRUITING

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, 453100, China

RECRUITING

Xinyang Central Hospital

Xinyang, Henan, 464000, China

RECRUITING

Yanshi People's Hospital

Yanshi, Henan, 471900, China

RECRUITING

Zhengzhou First People's Hospital

Zhengzhou, Henan, 450004, China

RECRUITING

Zhengzhou Cardiovascular Hospital

Zhengzhou, Henan, 450006, China

RECRUITING

Zhengzhou Central Hospital

Zhengzhou, Henan, 450007, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

People's Hospital of Zhengzhou

Zhengzhou, Henan, 450053, China

RECRUITING

The First People's Hospital of Xinmi

Zhengzhou, Henan, 452370, China

RECRUITING

Zhoukou Central Hospital

Zhoukou, Henan, 466000, China

RECRUITING

The First People's Hospital of Zhumadian

Zhumadian, Henan, 463000, China

RECRUITING

Zhumadian Central Hospital

Zhumadian, Henan, 463000, China

RECRUITING

Jincheng People's Hospital

Jincheng, Shanxi, 048026, China

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Nitroprusside; Tirofiban; Control Groups

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Ferricyanides; Cyanides; Anions; Ions; Electrolytes; Inorganic Chemicals; Ferric Compounds; Iron Compounds; Hydrogen Cyanide; Nitrogen Compounds; Tyrosine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Chunguang Qiu, Phd

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunguang Qiu, Phd

CONTACT

+86-13803898806; qcg123@163.com

Liang Pan, MD

CONTACT

+86-15003851743; huzhoupanliang@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Cardiovascular Medicine

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 23, 2018
• Study Start: January 7, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2019
• Last Updated: January 23, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (28)