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Effect of intracoronary injection of the prourokinase on myocardial injury in STEMI patients undergoing primary percutaneous coronary intervention

Effect of intracoronary injection of the prourokinase on myocardial injury in STEMI patients undergoing primary percutaneous coronary intervention——a single-center, perspective, randomized case-controlled, open-label study based on cardiac magnetic resonance imaging

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016207
Enrollment
Unknown
Registered
2018-05-18
Start date
2018-06-01
Completion date
Unknown
Last updated
2019-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ST-segment elevation myocardial infarction

Interventions

experimental group:intracoronary injection of the prourokinase and standard care
control group:none

Sponsors

Cangzhou Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. duration from onset of symptoms (typical ischaemic chest pain) to randomisation = 30 mins and >= 0.1 mV ST-segment elevation in >= 2 limb leads or >= 0.2 mV ST-segment elevation in >= 2 contiguous precordial leads; 2. aged 18–75 years; 3. Patients at risk of no reflow were selected if >= 1 of the following inclusion criteria should be met: 1) clinical history that included myocardial infarction, increased age (i.e., 65 years of age or older), duration of symptoms > 6h; 2) culprit coronary artery abnormalities including an occluded artery (Thrombolysis In Myocardial Infarction [TIMI] flow grade 0/1) at initial angiography, heavy thrombus burden (TIMI grade 2 or higher), long lesion length (>24 mm), small vessel diameter (i.e., 50%. 4. agree to enroll the trial and give the informed consent.

Exclusion criteria

Exclusion criteria: 1. presenting any of contraindication for fibrinolytic: 1) absolute: precious intracranial haemorrhage or stroke of unknown origin at anytime; ischaemic stroke in the preceding 6 months; central nervous system damage or neoplasms or arterioveous malformation; recent major trauma/surgery/head injury (within the preceding month); gastrointestinal bleeding within the past month; known bleeding disorder (excluding menses); aortic dissection; non-compressible punctures in the past 24 hours (e.g.liver biopsy,lumbar puncture); 2) relative: transient ischaemic attack in the preceding 6 months; oral anticoagulant therapy;pregnancy or within 1 week postpartum; refractory hypertension (SBP> 180 mmHg and/or DBP >110mmHg); advanced liver disease; infective endocarditis; active peptic ulcer; prolonged or traumatic resuscitation; 2. life expectancy<12 months; 3. a contraindication to magnetic resonance imaging (MRI) (e.g.some types of permanent pacemaker which can not use in MRI environment;ICD;claustrophobia;intracranial metal implants); 4. cardiogenic shock; 5. with history of old myocardial infarction.

Design outcomes

Primary

MeasureTime frame
Final MSI;

Secondary

MeasureTime frame
ST segment elevation resolution;All-cause mortality in hospital;Cardiac death in hospital;Re-infarction in hospital;Left ventricular end diastolic volume at early phase;Left ventricular end systolic volume at early phase;LVEF at early phase;Intramyocardial haemorrhage at early phase;Infartion size at early phase;Microvescular obstruction at early phase;Myocardium at risk at early phase;Myocardial salvage index at early phase;Regional left ventricular systolic wall stress at early phase;all-cause mortality 1 month after PPCI;Cardiac death 1 month after PPCI;Re-infarction 1 month after PPCI;Left ventricular end diastolic volume 1 month after PPCI;Left ventricular end systolic volume 1 month after PPCI;Left ventricular ejection fraction 1 month after PPCI;Intramyocardial haemorrhage 1 month after PPCI;Final infarction size 1 month after PPCI;Microvescular obstruction 1 month after PPCI;Final myocardium at risk 1 month after PPCI;Myocardial blush grade after PPCI;rate of no-reflow after PPCI;

Countries

China

Contacts

Public ContactJun Zhang

Cangzhou Central Hospital

dr_zhangj@sina.com+86 13315777566

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 26, 2026