ST-elevation Myocardial Infarction (STEMI) Clinical Trial
— REFLO-STEMIOfficial title:
Randomized Controlled Trial Comparing Intracoronary Administration of Adenosine or Sodium Nitroprusside to Control for Attenuation of Microvascular Obstruction During Primary Percutaneous Coronary Intervention
The purpose of this study is to determine whether intra-coronary adenosine or sodium nitroprusside (SNP) delivered selectively via a thrombus aspiration catheter (or if unsuccessful via a coronary microcatheter) following thrombus aspiration in Primary Percutaneous Coronary Intervention (P-PCI) reduces microvascular obstruction (MVO) parameters and infarct size as measured with cardiac MRI, compared with standard treatment following thrombus aspiration in patients presenting with ST-elevation myocardial infarction (STEMI).
Status | Completed |
Enrollment | 247 |
Est. completion date | December 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - = 18 years age. - Informed ASSENT (verbal consent) prior to angiography. - STEMI = 6 hrs of symptom onset, requiring primary reperfusion by PCI. - Single-vessel coronary artery disease (non culprit disease =70% stenosis at angiography) - TIMI flow 0/I at angiography. Exclusion Criteria: - Contraindications to: P-PCI *, CMR**, contrast agents, or study medications: Adenosine***, SNP****, Aspirin, Thienopyridine and Bivalirudin. - SBP = 90mmHg - Cardiogenic Shock - Previous Q wave myocardial infarction - Culprit lesion not identified or located in a by-pass graft - Stent thrombosis. - Left main disease. - Known severe asthma. - Known stage 4 or 5 chronic kidney disease (eGFR<30ml/min). - Pregnancy. Notes: - * Exclusion criteria for P-PCI (presentation timing, inadequate arterial access etc); patient unable to tolerate "prolonged" PCI procedure (in operators' opinion). - ** Absolute contra-indication to CMR (Pacemaker, ICD, intra-cranial metal clips). - *** Contraindications to Adenosine (known hypersensitivity to Adenosine, sick sinus syndrome, second or third degree atrio-ventricular block - except in patients with functioning artificial pacemaker, long QT syndrome has been defined as QTc > 450 ms at baseline). ECG will be undertaken just after the first dose of the study drug and QT/QTc will be recorded and compared to the baseline. If the QTc recorded after the first dose of the study drug exceeds 450ms or there is an increase in the QT/QTc of > 60 ms from baseline, the second dose will be abandoned and this will be recorded. - **** Contraindications to SNP (known hypersensitivity to SNP, compensatory hypertension - as may be seen in arteriovenous shunts or coarctation of the aorta, high output failure, congenital optic atrophy or tobacco amblyopia). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United Kingdom | University Hospital | Coventry | West Midlands |
United Kingdom | Leeds General Infirmary | Leeds | West Yorkshire |
United Kingdom | Glenfield Hospital | Leicester | Leicestershire |
United Kingdom | Freeman Hospital | Newcastle upon Tyne | Tyne and Wear |
Lead Sponsor | Collaborator |
---|---|
University Hospitals, Leicester |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | CMR measured infarct size (% LV mass) | 48-72 hours post procedure | Yes | |
Secondary | CMR incidence and extent of MVO (% LV mass) | 48-72 hours post procedure | Yes | |
Secondary | CMR measured myocardial salvage index, haemorrhage, LV EF and volumes | 48-72 hours post procedure | Yes | |
Secondary | Myocardial Blush Grade assessed by validated computer software 'Quantitative Blush Evaluator' (QuBE | During P-PCI | No | |
Secondary | Incidence pre- and post- procedure angiographic true "no-reflow" | During P-PCI | No | |
Secondary | Any in-patient clinical events | Includes: coronary artery re-occlusion, need for repeat PCI, recurrent chest pain with new ECG changes, incidence of clinical heart failure (symptoms plus basal crackles plus X-ray evidence of pulmonary congestion) and proven cerebrovascular accident (CVA). | Within 6 months from presentation with, and PCI for, STEMI | Yes |
Secondary | Overall MACE | MACE: composite of death, need for target lesion revascularization, recurrent MI, severe heart failure, and CVA. | 1 month | Yes |
Secondary | Degree of ST segment resolution on ECG | Assessed immediately following P-PCI (expected on average 1 hour) | No | |
Secondary | Echocardiographic assessment of LV | To include end systolic/diastolic volumes, EF +/- wall motion index | 6-8 weeks post-procedure/MI | No |
Secondary | Corrected TIMI Frame Count | TIMI frame count or TFC is defined as the number of cineframes required for contrast to reach a standardized distal coronary landmark in the culprit vessel. | During procedure | No |
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