N/A
N=1,500
Remote Ischemic Conditioning in Patients With Acute Stroke (RESIST)
Stroke, Acute · Ischemic Stroke · Hemorrhagic Stroke · Intracerebral Hemorrhage · Cerebrovascular Disorders
Bottom Line
View on ClinicalTrials.gov: NCT03481777 ↗Enrolled (actual)
1,500
Serious AEs
46.1%
Results posted
Jan 2025
Primary outcome: Primary: Modified Rankin Scale at 3 Months in Acute Stroke (AIS and ICH) — 2; 1 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Remote Ischemic Conditioning (Device); Sham Remote Ischemic Conditioning (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Grethe Andersen
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Modified Rankin Scale at 3 Months in Acute Stroke (AIS and ICH) |
2; 1 | — |
| SECONDARY Difference Neurological Impairment During the First 24 Hours |
-1; -2 | — |
| SECONDARY Clinical Outcome (Modified Rankin Scale (mRS) at 3 Months in Acute Ischemic Stroke |
1; 1 | — |
| SECONDARY Clinical Outcome (Modified Rankin Scale (mRS) at 3 Months in Acute Ischemic Stroke Receiving Reperfusion Therapy |
1; 1 | — |
| SECONDARY Clinical Outcome (Modified Rankin Scale (mRS) at 3 Months in Patients With Intracerebral Hemorrhage (ICH) |
3; 3 | — |
| SECONDARY Difference in Proportion of Patients With Complete Remission of Symptoms Within 24 Hours (TIA; Both With and Without DWI) |
96; 90 | — |
| SECONDARY Major Adverse Cardiac and Cerebral Events (MACCE) |
57; 62 | — |
| SECONDARY Early Neurological Improvement in Acute Ischemic Stroke Patients (AIS) |
108; 131 | — |
| SECONDARY Early Neurological Improvement in Patients With Intracerebral Hemorrhage (ICH) |
— | — |
| SECONDARY Quality of Life Measures at 3 Months in AIS and ICH Patients |
— | — |
| SECONDARY Bed-day Use in AIS and ICH Patients |
— | — |
| SECONDARY Three-month and One-year Mortality |
— | — |
Summary
Our primary aim is to investigate whether remote ischemic conditioning (RIC) as an adjunctive treatment can improve long-term recovery in acute stroke patients as an adjunct to standard treatment.
Eligibility Criteria
Inclusion Criteria
- Male and female patients (≥ 18 years)
- Prehospital putative stroke (Prehospital Stroke Score, PreSS >= 1)
- Onset of stroke symptoms < 4 hours before RIC/Sham-RIC
- Independent in daily living before symptom onset (mRS ≤ 2)
Exclusion Criteria
- Intracranial aneurisms, intracranial arteriovenous malformation, cerebral neoplasm or abscess
- Pregnancy
- Severe peripheral arterial disease in the upper extremities
- Concomitant acute life-threatening medical or surgical condition
- Arteriovenous fistula in the arm selected for RIC
Data sourced from ClinicalTrials.gov (NCT03481777). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.