Efficacy of Intracoronary Infusion of Different Medicine in STEMI Patients Undergoing Primary PCI

August 14, 2017 updated by: RenJi Hospital

Efficacy of Intracoronary Infusion of Different Medicine With Targeted Perfusion Catheter on Myocardial Perfusion in Patients With STEMI Undergoing Primary PCI:an Open,Prospective,Randomized,Multicenter Trial.

The study intends to evaluate the efficacy of different medicine delivering by targed perfusion catheter incoronary administration on epicardial, myocardial perfusion and clinical outcomes in STEMI patients undergoing primary PCI.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The goal of STEMI therapy is to successfully restore both epicardial blood flow and myocardial perfusion. PCI has been documented as being the most effective method for restoration of epicardial blood flow. However, epicardial blood flow does not necessarily equate to myocardial perfusion; not every patient with TIMI 3 flow after successful PCI achieves effective myocardial tissue-level perfusion. Although epicardial TIMI 3 flow could be restored in >90% of STEMI patients undergoing PCI, normalization of myocardial perfusion was achieved less frequently, with detrimental impacts on survival。 Currently, there are two main methods of angiographic assessment of myocardial perfusion: TIMI myocardial perfusion grading (TMPG), described by Gibson et al. and myocardial blush grading (MBG), described by Van't Hof et al. These established myocardial perfusion parameters, TMPG and MBG, have been widely used in various important trials and are reported to be highly useful in predicting clinical outcomes. However, visual assessment of these methods is categorical, subjective, and operator dependent. TIMI Myocardial Perfusion Frame Count (TMPFC), a novel and objective method that measures the filling and clearance of contrast in the myocardium using cine-angiographic frame-counting, was developed by our center to quantify myocardial tissue- level perfusion and was proved to be a predictive value on clinical prognosis.

Currently, there are two main types of interventions to improve myocardial perfusion . One kind is the mechanical method, which included thrombus aspiration catheter and the distal protective devices. It has been confirmed that the mechanical method can effectively improve epicardial and myocardial perfusion in patient with part of large vessels and high burden thrombus. But for patients with small vessels and no obvious visual thrombus, the efficacy is not significant.

The other kind intervention is medicine which included GP IIb/IIIa receptor antagonist , adenosine , sodium nitroprusside, verapamil etc. Part of the drugs have some effect but the overall clinical efficacy is still not satisfied.

The study intends to use targeted perfusion catheter to deliver drug to the distal targeted blood vessels. TMPFC and TMPG are applied to evaluate the efficacy of treatment with Nicorandil versus Alprostadil on myocardial tissue-level perfusion in STEMI patients undergoing primary PCI.

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • ShangHai, China
        • Ren Ji Hospital Afflited to School of Medicine, Shanghai Jiao Tong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: over 18 or 18 years old, less than 75 years old;
  • Patents with myocardial infarction who have symptom onset within 6h before randomization;
  • ECG: ≥2 mm ST-segment elevation in 2 contiguous precordial leads or ≥1 mm ST-segment elevation in 2 contiguous extremity leads ;
  • Signed informed consent form prior to trial participation.

Exclusion Criteria:

  1. Evidence of cardiac rupture;
  2. ECG: new left bundle branch block;
  3. Thrombolysis contradictions:

  4. Severe complication

    • Other diseases with life expectancy ≤12 months;
    • Any history of Severe renal or hepatic dysfunction(hepatic failure, cirrhosis, portal hypertension and active hepatitis); Neutropenia, thrombocytopenia ; Known acute pancreatitis;
    • Known acute pericarditis and/or subacute bacterial endocarditis;
    • Arterial aneurysm, arterial/venous malformation and aorta dissection;

  5. Complex heart condition

    • Cardiogenic shock(SBP <90 mmHg after fluid infusion or SBP<100 mmHg after vasoactive drugs);
    • PCI within previous 1 month or Previous coronary-artery bypass surgery(CABG);
    • Previously known multivessel coronary artery disease not suitable for revascularization;
    • Hospitalisation for cardiac reason within past 48 hours;

  6. Not suitable for clinical trial

    • Inclusion in another clinical trial;
    • Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 7 days;
    • Pregnancy or lactating;
    • Body weight <40kg or >125kg;
    • Known hypersensitivity to any drug that may appear in the study;
    • Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: alprostadil
alprostadil,2ug, dilivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients
Drug: Alprostadil
alprostadil,2ug, dilivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients
EXPERIMENTAL: nicorandil
nicorandil,2mg, dilivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients
Drug: Nicorandil
Nicorandil,2mg, dilivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients
PLACEBO_COMPARATOR: nitroglycerin
nitroglycerin,200ug, dilivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients
Drug: Nitroglycerin
Nitroglycerin,200ug, dilivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TIMI Myocardial Perfusion Frame Count (TMPFC)
Time Frame: One mins after PCI
TMPFC is a novel method to standardize and quantify myocardial perfusion by timing the filling and washout of contrast in the myocardium using cine-angiographic frame-counting. Briefly, the first frame of TMPFC was defined as the frame that clearly demonstrated the first appearance of myocardial blush beyond the IRA (F1). The last frame of TMPFC was then defined as the frame where contrast or myocardial blush disappeared (F2). TMPFC is F2-F1 frame counts at a filming rate of 15 frames/sec, or (F2-F1)×2 frame counts at the corrected filming rate of 30 frames/sec
One mins after PCI
TIMI Myocardial Perfusion Frame Count (TMPFC)
Time Frame: One mins after intracoronary medicine infusion post-PCI
TMPFC is a novel method to standardize and quantify myocardial perfusion by timing the filling and washout of contrast in the myocardium using cine-angiographic frame-counting. Briefly, the first frame of TMPFC was defined as the frame that clearly demonstrated the first appearance of myocardial blush beyond the IRA (F1). The last frame of TMPFC was then defined as the frame where contrast or myocardial blush disappeared (F2). TMPFC is F2-F1 frame counts at a filming rate of 15 frames/sec, or (F2-F1)×2 frame counts at the corrected filming rate of 30 frames/sec
One mins after intracoronary medicine infusion post-PCI
TIMI Myocardial Perfusion Grade (TMPG)
Time Frame: One mins after PCI
TMPG is an angiographic measure of myocardial perfusion
One mins after PCI
TIMI Myocardial Perfusion Grade (TMPG)
Time Frame: One mins after intracoronary medicine infusion post-PCI
TMPG is an angiographic measure of myocardial perfusion
One mins after intracoronary medicine infusion post-PCI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TIMI Flow Grade (TFG)
Time Frame: One mins after PCI
TIMI Flow Grade (TFG)assesses flow in the epicardial arteries
One mins after PCI
TIMI Flow Grade (TFG)
Time Frame: One mins after intracoronary medicine infusion post-PCI
TIMI Flow Grade (TFG)assesses flow in the epicardial arteries
One mins after intracoronary medicine infusion post-PCI
TIMI Frame Count (CTFC)
Time Frame: One mins after PCI
CTFC is a continuous measurement assessing flow in the epicardial arteries.
One mins after PCI
TIMI Frame Count (CTFC)
Time Frame: One mins after intracoronary medicine infusion post-PCI
CTFC is a continuous measurement assessing flow in the epicardial arteries.
One mins after intracoronary medicine infusion post-PCI
ST-segment Resolution
Time Frame: 90 mins after PCI
Resolution of the initial sum of ST-segment elevation ≥ 70%
90 mins after PCI
Myocardial-specific isoenzyme of creatine kinase (CK-MB) enzyme levels peri-PCI
Time Frame: Within 0 to 48 hours after enrollment
Infarct size is measured by the myocardial-specific isoenzyme of creatine kinase (CK-MB) area under the curve, calculated by the linear-trapezoidal method. If the baseline or last value is missing, the corresponding value will be set to zero. For missing values of intermediate time points, linear interpolation is used.
Within 0 to 48 hours after enrollment
Wall motion score index (WMSI) and LVEF by echocardiography
Time Frame: Echocardiography was performed 3-5 days after PCI
Echocardiographic index includes WMSI and LVEF
Echocardiography was performed 3-5 days after PCI
CMR defined MVO
Time Frame: 3-5 days post-infarct
MVO was defined as hypoenhanced area within infracted zone measured by CMR
3-5 days post-infarct
Infarct Size by Cardiac Magnetic Resonance Imaging (CMR)
Time Frame: 3-5 days post-infarct
Infarct size (expressed as a percentage of LV myocardial mass) between two groups 3-5 days post-infarct assessed by the extent of late gadolinium enhancement on CMR
3-5 days post-infarct

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE
Time Frame: in-hospital (within 14 days)
MACE includes all cause death, reinfarction, target vessel revascularization, and stroke
in-hospital (within 14 days)
MACE
Time Frame: 30 days after randomization
MACE includes all cause death, reinfarction, target vessel revascularization, and stroke
30 days after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Collaborators

Shanghai 10th People's Hospital
Ruijin Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai 6th People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2017

Primary Completion (ANTICIPATED)

June 30, 2019

Study Completion (ANTICIPATED)

June 30, 2019

Study Registration Dates

First Submitted

August 10, 2017

First Submitted That Met QC Criteria

August 14, 2017

First Posted (ACTUAL)

August 17, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 17, 2017

Last Update Submitted That Met QC Criteria

August 14, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16CR1012A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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