Paramedic Initiated Lisinopril For Acute Stroke Treatment

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to investigate the use of lisinopril to lower blood pressure in stroke patients, pre-hospital, by research-trained paramedics.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
• Collaborators: North East Ambulance Service NHS Foundation Trust; North East Ambulance Service NHS Trust; Northumbria Healthcare NHS Foundation Trust
• Treatments: Angiotensin-Converting Enzyme Inhibitors; Lisinopril

Criteria

Inclusion Criteria:

• Adults ≥ 40 years old

• New unilateral arm weakness thought to be due to acute stroke within 3 hours of symptom onset

• Hypertension as defined by systolic BP >160mm Hg on two consecutive seated or lying readings taken 5 - 10 minutes apart

• Conscious (eyes open spontaneously ie "A" on Alert, Voice, Pain, Unresponsive (AVPU) scale)

• Patient being transported to a PIL-FAST trial site (i.e. Royal Victoria Infirmary, North Tyneside General Hospital and Wansbeck General Hospital)

• Verbal consent obtained from participant or next of kin

Exclusion criteria:

• Age < 40 years

• Females who are pregnant, lactating or at risk of pregnancy (i.e. who are not surgically sterile or at least 1 year post last menstrual period). Females < 56 years of age consented by a relative will be excluded as menstrual history may be unknown.

• Any presentation of suspected stroke without unilateral arm weakness

• Cannot establish that stroke onset time (i.e. when patient was last seen well without symptoms) was within the last 3 hours

• Systolic BP < 160mm Hg

• Reduced level of consciousness (below "A" on AVPU scale)

• Patient not being transported to PIL-FAST trial site

• Absence of participant or next of kin consent

• Known to be taking ACE-inhibitor or Angiotensin II Receptor Blocker medication already

• Known sensitivity to lisinopril or other ACE-inhibitor medication

• Pulse > 120 beats per minute

• Seizure activity in this illness episode (witnessed or history)

• Hypoglycaemia (blood glucose < 3.5 mmols/l)

• Cannot walk independently prior to stroke (walking stick / frame is allowed)

• Obvious understanding or memory problems when next of kin is absent

• Significant head trauma or brain surgery in the last 3 months

• Known renal failure

• Known liver failure (or currently jaundiced)

• Uncontrolled heart failure (breathlessness at rest)

• Receiving palliative care for known malignancy

• Currently enrolled in a clinical trial assessing a study drug