Trial · NCT03481777
Remote Ischemic Conditioning in Patients With Acute Stroke (RESIST)
NCT03481777, Not applicable, Completed, Grethe Andersen; results first posted 2025-01-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Remote Ischemic Conditioning in Patients With Acute Stroke (RESIST). Trials, record NCT03481777. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03481777
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Remote Ischemic Conditioning in Patients With Acute Stroke (RESIST)
- NCT number
- NCT03481777
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,500 participants, actual
- Lead sponsor
- Grethe Andersen
- Conditions
- Stroke, Acute, Ischemic Stroke, Hemorrhagic Stroke, Intracerebral Hemorrhage, Cerebrovascular Disorders, Central Nervous System Diseases
- Interventions
- Remote Ischemic Conditioning, Sham Remote Ischemic Conditioning
- First posted
- 2018-03-29
- Last updated
- 2025-01-27
- Results first posted
- 2025-01-27
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Modified Rankin Scale at 3 Months in Acute Stroke (AIS and ICH) | 3 months | Clinical outcome (modified Rankin Scale) at 3 months in acute stroke patients (target diagnosis) (generalized ordinal logistic regression). The assessment will performed by two independent telephone or face-to-face assessors. the mRS range from 0 to 6, with higher scores representing worse outcome (mRS 0, no symptoms; mRS 6, death) If disagreement occurs the patient will be contacted by a third assessor (face-to-face or telephone) who is blinded to the intervention who will assess the level of dependency. * If disagreement occurs between two telephone assessments - a third, and final, telephone or face-to-face assessment will be made. * If disagreement occurs between one face-to-face assessment and one telephone assessment * the face-to-face will be considered the final assessment * If disagreement occurs between two face-to-face assessments - a third, and final, telephone or face-to-face assessment will be made. |
| Secondary | Difference Neurological Impairment During the First 24 Hours | 24 hours | Neurological deficits are documented using Prehospital Stroke Score (PreSS). Prehospital Stroke Score is assessed in the the ambulance and at 24-hour or at discharge (if discharge occurs before 24 hours). The PreSS score consists of the Cincinnati Prehospital Stroke Scale (CPSS) with an additional opportunity to report other neurological symptoms (e.g. ataxia, sensory disturbances and visual field loss), and PASS (Prehospital Acute Stroke Severity Scale). The PreSS score range from 0-6, with 6 representing the most severe neurological deficits. |
| Secondary | Clinical Outcome (Modified Rankin Scale (mRS) at 3 Months in Acute Ischemic Stroke | 3 months | Clinical outcome (modified Rankin Scale) at 3 months in acute stroke patients (target diagnosis) (generalized ordinal logistic regression). TThe assessment will performed by two independent telephone or face-to-face assessors. the mRS range from 0 to 6, with higher scores representing worse outcome (mRS 0, no symptoms; mRS 6, death) If disagreement occurs the patient will be contacted by a third assessor (face-to-face or telephone) who is blinded to the intervention who will assess the level of dependency. If disagreement occurs between two telephone assessments - a third, and final, telephone or face-to-face assessment will be made. If disagreement occurs between one face-to-face assessment and one telephone assessment the face-to-face will be considered the final assessment If disagreement occurs between two face-to-face assessments - a third, and final, telephone or face-to-face assessment will be made. |
| Secondary | Clinical Outcome (Modified Rankin Scale (mRS) at 3 Months in Acute Ischemic Stroke Receiving Reperfusion Therapy | 3 months | Clinical outcome (modified Rankin Scale) at 3 months inacute ischemic stroke receiving reperfusion therapy (generalized ordinal logistic regression). The assessment will performed by two independent telephone or face-to-face assessors. the mRS range from 0 to 6, with higher scores representing worse outcome (mRS 0, no symptoms; mRS 6, death) If disagreement occurs the patient will be contacted by a third assessor (face-to-face or telephone) who is blinded to the intervention who will assess the level of dependency. If disagreement occurs between two telephone assessments - a third, and final, telephone or face-to-face assessment will be made. If disagreement occurs between one face-to-face assessment and one telephone assessment the face-to-face will be considered the final assessment If disagreement occurs between two face-to-face assessments - a third, and final, telephone or face-to-face assessment will be made. |
| Secondary | Clinical Outcome (Modified Rankin Scale (mRS) at 3 Months in Patients With Intracerebral Hemorrhage (ICH) | 3 months | Clinical outcome (modified Rankin Scale) at 3 months in patients with intracerebral hemorrhage (ICH) (generalized ordinal logistic regression). The assessment will performed by two independent telephone or face-to-face assessors. the mRS range from 0 to 6, with higher scores representing worse outcome (mRS 0, no symptoms; mRS 6, death) If disagreement occurs the patient will be contacted by a third assessor (face-to-face or telephone) who is blinded to the intervention who will assess the level of dependency. If disagreement occurs between two telephone assessments - a third, and final, telephone or face-to-face assessment will be made. If disagreement occurs between one face-to-face assessment and one telephone assessment the face-to-face will be considered the final assessment If disagreement occurs between two face-to-face assessments - a third, and final, telephone or face-to-face assessment will be made. |
| Secondary | Difference in Proportion of Patients With Complete Remission of Symptoms Within 24 Hours (TIA; Both With and Without DWI) | 3 months | Difference in proportion of patients with complete remission of symptoms within 24 hours (TIA; both with and without DWI) Diagnosis of TIA is documented in the electronic case report form |
| Secondary | Major Adverse Cardiac and Cerebral Events (MACCE) | 3 months | MACCE is defined as: Cardiovascular events (cardiovascular death, myocardial infarction, acute ischemic or hemorrhagic stroke) Cardiovascular death: Death from known cardiovascular cause or sudden death from unknown cause (no identified cause of death in medical history and/or autopsy) Acute myocardial infarction: Admission with a discharge diagnosis of ST-elevation myocardial infarction (STEMI) and non-ST elevation myocardial infarction (NSTEMI) and unstable angina pectoris (UAP) Stroke: Admission with a discharge diagnosis of acute ischemic or hemorrhagic stroke. Evaluation is performed using the Danish National Patient Register (LPR) and the DSR at two time points (6 and 15 months after the inclusion of the last patient). Diagnosis of AIS/TIA, ICH and MI (STEMI, NSTEMI, and UAP) are made according to national clinical practice guidelines. |
| Secondary | Early Neurological Improvement in Acute Ischemic Stroke Patients (AIS) | 24 hours | Reduction in National Institute of Health Stroke Scale (NIHSS) ≥ 4 (baseline versus 24-Hour NIHSS). NIHSS range from 0 to 42, with higher scores representing worse neurological function. |
| Secondary | Early Neurological Improvement in Patients With Intracerebral Hemorrhage (ICH) | 24 hours | Reduction in National Institute of Health Stroke Scale (NIHSS) ≥ 4 (baseline versus 24-Hour NIHSS). NIHSS range from 0 to 42, with higher scores representing worse neurological function. |
| Secondary | Quality of Life Measures at 3 Months in AIS and ICH Patients | 3 months | Quality of life (WHO-5 Well-Being Index) measures in AIS and ICH patients at 3 months |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Modified Rankin Scale at 3 Months in Acute Stroke (AIS and ICH) | 3 months | units on a scale | MEDIAN | |
| SECONDARY | Difference Neurological Impairment During the First 24 Hours | 24 hours | 24-hour difference in prehospital stroke score | units on a scale | MEDIAN |
| SECONDARY | Clinical Outcome (Modified Rankin Scale (mRS) at 3 Months in Acute Ischemic Stroke | 3 months | Acute ischemic stroke patients | units on a scale | MEDIAN |
| SECONDARY | Clinical Outcome (Modified Rankin Scale (mRS) at 3 Months in Acute Ischemic Stroke Receiving Reperfusion Therapy | 3 months | Patients with acute ischemic stroke who were treated with reperfusion therapies (intravenous thrombolysis and/or trombectomy) | units on a scale | MEDIAN |
| SECONDARY | Clinical Outcome (Modified Rankin Scale (mRS) at 3 Months in Patients With Intracerebral Hemorrhage (ICH) | 3 months | Patients diagnosed with intracerebral hemorrhage | units on a scale | MEDIAN |
| SECONDARY | Difference in Proportion of Patients With Complete Remission of Symptoms Within 24 Hours (TIA; Both With and Without DWI) | 3 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Major Adverse Cardiac and Cerebral Events (MACCE) | 3 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Early Neurological Improvement in Acute Ischemic Stroke Patients (AIS) | 24 hours | Target population with acute stroke | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Early Neurological Improvement in Patients With Intracerebral Hemorrhage (ICH) | 24 hours | |||
| SECONDARY | Quality of Life Measures at 3 Months in AIS and ICH Patients | 3 months |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Modified Rankin Scale at 3 Months in Acute Stroke (AIS and ICH) | Remote Ischemic Conditioning (RIC) | 2 | Inter-Quartile Range 1 to 3 | units on a scale | |
| Modified Rankin Scale at 3 Months in Acute Stroke (AIS and ICH) | Sham | 1 | Inter-Quartile Range 1 to 3 | units on a scale | |
| Difference Neurological Impairment During the First 24 Hours | Remote Ischemic Conditioning | -1 | Inter-Quartile Range -2 to 0 | units on a scale | |
| Difference Neurological Impairment During the First 24 Hours | Sham - Remote Ischemic Conditioning | -2 | Inter-Quartile Range -2 to 0 | units on a scale | |
| Clinical Outcome (Modified Rankin Scale (mRS) at 3 Months in Acute Ischemic Stroke | Remote Ischemic Conditioning (RIC) | 1 | Inter-Quartile Range 1 to 2 | units on a scale | |
| Clinical Outcome (Modified Rankin Scale (mRS) at 3 Months in Acute Ischemic Stroke | Sham | 1 | Inter-Quartile Range 0 to 3 | units on a scale | |
| Clinical Outcome (Modified Rankin Scale (mRS) at 3 Months in Acute Ischemic Stroke Receiving Reperfusion Therapy | Remote Ischemic Conditioning (RIC) | 1 | Inter-Quartile Range 1 to 3 | units on a scale | |
| Clinical Outcome (Modified Rankin Scale (mRS) at 3 Months in Acute Ischemic Stroke Receiving Reperfusion Therapy | Sham | 1 | Inter-Quartile Range 1 to 3 | units on a scale | |
| Clinical Outcome (Modified Rankin Scale (mRS) at 3 Months in Patients With Intracerebral Hemorrhage (ICH) | Remote Ischemic Conditioning (RIC) | 3 | Inter-Quartile Range 2 to 5 | units on a scale | |
| Clinical Outcome (Modified Rankin Scale (mRS) at 3 Months in Patients With Intracerebral Hemorrhage (ICH) | Sham | 3 | Inter-Quartile Range 2 to 5 | units on a scale |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Remote Ischemic Condtioning (RIC) | 749 | |
| Overall Study | STARTED | Sham Remote Ischemic Conditioning | 751 | |
| Overall Study | COMPLETED | Remote Ischemic Condtioning (RIC) | 436 | |
| Overall Study | COMPLETED | Sham Remote Ischemic Conditioning | 466 | |
| Overall Study | NOT COMPLETED | Remote Ischemic Condtioning (RIC) | 313 | |
| Overall Study | NOT COMPLETED | Sham Remote Ischemic Conditioning | 285 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Upper extremity pain during treatment and/or skin petechia | Musculoskeletal and connective tissue disorders | Remote Ischemic Conditioning (RIC) | 54 | 713 | 54 |
| other | Upper extremity pain during treatment and/or skin petechia | Musculoskeletal and connective tissue disorders | Sham | 11 | 720 | 11 |
| serious | SAE | Cardiac disorders | Remote Ischemic Conditioning (RIC) | 335 | 713 | 335 |
| serious | SAE | Cardiac disorders | Sham | 325 | 720 | 325 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Remote Ischemic Conditioning (RIC) | 41 | 713 |
| Total, all-cause mortality | Sham | 47 | 720 |
| Total, other adverse events | Remote Ischemic Conditioning (RIC) | 54 | 713 |
| Total, other adverse events | Sham | 11 | 720 |
| Total, serious adverse events | Remote Ischemic Conditioning (RIC) | 335 | 713 |
| Total, serious adverse events | Sham | 325 | 720 |
Source ClinicalTrials.gov
Papers10
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Remote Ischemic Conditioning (RIC) vs Sham: Major Adverse Cardiac and Cerebral Events (MACCE) | Trial comparisons |
| Remote Ischemic Conditioning (RIC) vs Sham: Early Neurological Improvement in Acute Ischemic Stroke Patients (AIS) | Trial comparisons |
| Remote Ischemic Conditioning (RIC) vs Sham: Difference in Proportion of Patients With Complete Remission of Symptoms Within 24 Hours (TIA; Both With and Without DWI) | Trial comparisons |
| Remote Ischemic Conditioning (RIC) vs Sham: deaths from any cause | Trial comparisons |
| Remote Ischemic Conditioning (RIC) vs Sham: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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