Ischemic StrokeASIISTNCT03318679
Assessment of Markers of Stress in Acute Ischemic Stroke With Hyperglycemia
An observational study of Ischemic Stroke and Hyperglycemia, run by University of Minnesota at 1 site in United States.
Trial summary
Hyperglycemia is present in 50 percent of patients with acute ischemic stroke. Patients with hyperglycemia have higher in hospital, 30 and 90 day mortality and morbidity. Sixty percent of these patients have some form of diabetic syndrome, known or unknown. Remaining 40% of patients are not diabetic. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Ischemic Stroke, Hyperglycemia
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 25 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
Study population: Acute Ischemic Stroke Patients that present to University of Minnesota Medical Center and Hennipen County medical Center.
Who may be able to join
- Patients with acute Ischemic stroke that present to UMMC ER.
- Age 18-100.
- Subjects are hyperglycemic (defined as blood sugar above 130mg/dl).
Who cannot join
- Blood sugars less than 130mg/dl.
- Age less than 18 or more than 100.
- Difficult blood draw.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: "Is Non Diabetic Hyperglycemia in Acute Ischemic Stroke Part of a Systemic Stress Response"
Hyperglycemia is present in 50 percent of patients with acute ischemic stroke. Patients with hyperglycemia have higher in hospital, 30 and 90 day mortality and morbidity. Sixty percent of these patients have some form of diabetic syndrome, known or unknown. Remaining 40% of patients are not diabetic. Contrary to logic patients with non diabetic hyperglycemia (NDH) have statistically higher morbidity and mortality compared to the diabetic hyperglycemia (DH) cohort. So far multiple treatment trials (THIS, GRASP, GIST-UK, SHINE ongoing) with differing treatment goals have shown no clear benefit, however no obvious distinction was made along the diabetic and non-diabetic hyperglycemic groups.
If hyperglycemia in the acute phase was the only culprit in worsening the injury, then there should be no difference in the outcomes for DH and NDH. Existing data implies that the two categories are two distinct physiological entities that are thus not amenable to same treatment. Stating it simply NDH is not an insulin deficient state where as DH is.
Read more
Alternative possibility is that body and Neurons are accustomed to high sugars in diabetics and thus can tolerate higher sugars better during ischemic stroke compared to non diabetics.
The overarching hypothesis is that reducing blood sugars in NDH increases stroke volume and thus consequently worsens outcome.
Read the detailed description
1.1 Background Hyperglycemia is present in 50 percent of patients with acute ischemic stroke. Patients with hyperglycemia have higher in hospital, 30 and 90 day mortality and morbidity. Sixty percent of these patients have some form of diabetic syndrome, known or unknown. Remaining 40% of patients are not diabetic. Contrary to logic patients with non diabetic hyperglycemia (NDH) have statistically higher morbidity and mortality compared to the diabetic hyperglycemia (DH) cohort. So far multiple treatment trials (THIS, GRASP, GIST-UK, SHINE ongoing) with different treatment goals have shown no clear benefit.
If hyperglycemia in the acute phase was the only culprit in worsening the injury, then there should be no difference in the outcomes for DH and NDH. Existing data implies that the two categories are distinct physiological entities that are thus not amenable to same treatment. Stating it simply NDH is not an insulin deficient state where as DH is.
Alternative possibility is that body and Neurons are accustomed to high sugars in diabetics and thus can tolerate higher sugars better during ischemic stroke compared to non diabetics.
The overarching hypothesis is that reducing blood sugars in NDH increases stroke volume and thus consequently worsens outcome.
1.2 Investigational Agent: No planned investigational agent is tested as part of this study.
1.3 Pre-clinical Data Currently there is clear data that patients that present with acute ischemic stroke have higher (two times) mortality at discharge and 90 day mark. Multiple clinical studies so far have not revealed any clear benefit of treatment (GIST-UK). There do seem to be two distinct groups when it comes to hyperglycemia at presentation of DM, HG in association of Diabetes and without any history of Diabetes. The outcomes in the two groups vary greatly.
1.4 Clinical Data to Date Please see attached article with references.
1.5 Dose Rationale and Risk/Benefits There is no drug or device or intervention that will be tested in this study. This study involves collection of blood samples from the patients who meet the inclusion criteria. Our goal is to be able to see if there is any difference between the two groups of patients.
2 Study Objectives
Primary Objective: Assess difference in laboratory values between two groups of patients.
Null Hypothesis: There is no difference in laboratory values between DH and NDH
3 Study Design
3.1 General Design This is a exploratory study to assess the difference in the lab values in two groups of patients. Patients that present to University of Minnesota Medical Center with acute ischemic stroke and are hyperglycemic (Blood sugar of more than 130 mg/dl) will be eligible for the study. Pre-specified volume of blood will be collected for lab analysis. This study does not involve testing of any procedure, drug or device.
Step One - Identify patients that have Ischemic strokes and have hyperglycemia >130 mg/dl.
Step Two:
- Obtain Consent from patient or POA.
Step Three:(Once consent obtained) - Collect first set of blood samples from patients with the first blood draw between 0-8 hours from time of ER arrival. Second blood sample will be collected in 9-16 hours and a 3rd one in 17-24 hour period.
Step Four:
- No further data will be collected from patient. Study end point is difference in laboratory values between DH and NDH groups.
- Conditions
- Ischemic Stroke, Hyperglycemia
- Being tested
- No intervention is planned.
- Medical subject headings
- Ischemic Stroke, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention is planned.Other
None is planned
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the Bio markers of stress between Diabetic and Non diabetic patients that have acute ischemic stroke and hyperglycemia on presentation.
Lab values
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start1 Nov 2017
- Primary completion25 Dec 2019
- Study completion25 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rwoof A Reshi, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03318679
- Sponsor's protocol ID
- UMinnesota
- Acronym
- ASIIST
- Status last verified
- Mar 2021
- First submitted
- 25 Sep 2017
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reshi R, Streib C, Ezzeddine M, Biros M, Miller B, Lakshminarayan K, Anderson D, Ardelt A. Hyperglycemia in acute ischemic stroke: Is it time to re-evaluate our understanding? Med Hypotheses. 2017 Sep;107:78-80. doi: 10.1016/j.mehy.2017.08.017. Epub 2017 Aug 16.
PubMed 28915969
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Is Non Diabetic Hyperglycemia in Acute Ischemic Stroke Part of a Systemic Stress Response"
- ClinicalTrials.gov ID
- NCT03318679
- Acronym / sponsor ID
- ASIIST / UMinnesota
- Conditions
- Ischemic Stroke, Hyperglycemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 25 Dec 2019 (actual)
- Study completion
- 25 Dec 2020 (actual)
- First posted
- 24 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hyperglycemia is present in 50 percent of patients with acute ischemic stroke. Patients with hyperglycemia have higher in hospital, 30 and 90 day mortality and morbidity. Sixty percent of these patients have some form of diabetic syndrome, known or unknown. Remaining 40% of patients are not diabetic. Contrary to logic patients with non diabetic hyperglycemia (NDH) have statistically higher morbidity and mortality compared to the diabetic hyperglycemia (DH) cohort. So far multiple treatment trials (THIS, GRASP, GIST-UK, SHINE ongoing) with differing treatment goals have shown no clear benefit, however no obvious distinction was made along the diabetic and non-diabetic hyperglycemic groups.
If hyperglycemia in the acute phase was the only culprit in worsening the injury, then there should be no difference in the outcomes for DH and NDH. Existing data implies that the two categories are two distinct physiological entities that are thus not amenable to same treatment. Stating it simply NDH is not an insulin deficient state where as DH is.
Alternative possibility is that body and Neurons are accustomed to high sugars in diabetics and thus can tolerate higher sugars better during ischemic stroke compared to non diabetics.
The overarching hypothesis is that reducing blood sugars in NDH increases stroke volume and thus consequently worsens outcome.
Detailed description
1.1 Background Hyperglycemia is present in 50 percent of patients with acute ischemic stroke. Patients with hyperglycemia have higher in hospital, 30 and 90 day mortality and morbidity. Sixty percent of these patients have some form of diabetic syndrome, known or unknown. Remaining 40% of patients are not diabetic. Contrary to logic patients with non diabetic hyperglycemia (NDH) have statistically higher morbidity and mortality compared to the diabetic hyperglycemia (DH) cohort. So far multiple treatment trials (THIS, GRASP, GIST-UK, SHINE ongoing) with different treatment goals have shown no clear benefit.
If hyperglycemia in the acute phase was the only culprit in worsening the injury, then there should be no difference in the outcomes for DH and NDH. Existing data implies that the two categories are distinct physiological entities that are thus not amenable to same treatment. Stating it simply NDH is not an insulin deficient state where as DH is.
Alternative possibility is that body and Neurons are accustomed to high sugars in diabetics and thus can tolerate higher sugars better during ischemic stroke compared to non diabetics.
The overarching hypothesis is that reducing blood sugars in NDH increases stroke volume and thus consequently worsens outcome.
1.2 Investigational Agent: No planned investigational agent is tested as part of this study.
1.3 Pre-clinical Data Currently there is clear data that patients that present with acute ischemic stroke have higher (two times) mortality at discharge and 90 day mark. Multiple clinical studies so far have not revealed any clear benefit of treatment (GIST-UK). There do seem to be two distinct groups when it comes to hyperglycemia at presentation of DM, HG in association of Diabetes and without any history of Diabetes. The outcomes in the two groups vary greatly.
1.4 Clinical Data to Date Please see attached article with references.
1.5 Dose Rationale and Risk/Benefits There is no drug or device or intervention that will be tested in this study. This study involves collection of blood samples from the patients who meet the inclusion criteria. Our goal is to be able to see if there is any difference between the two groups of patients.
2 Study Objectives
Primary Objective: Assess difference in laboratory values between two groups of patients.
Null Hypothesis: There is no difference in laboratory values between DH and NDH
3 Study Design
3.1 General Design This is a exploratory study to assess the difference in the lab values in two groups of patients. Patients that present to University of Minnesota Medical Center with acute ischemic stroke and are hyperglycemic (Blood sugar of more than 130 mg/dl) will be eligible for the study. Pre-specified volume of blood will be collected for lab analysis. This study does not involve testing of any procedure, drug or device.
Step One - Identify patients that have Ischemic strokes and have hyperglycemia >130 mg/dl.
Step Two:
- Obtain Consent from patient or POA.
Step Three:(Once consent obtained) - Collect first set of blood samples from patients with the first blood draw between 0-8 hours from time of ER arrival. Second blood sample will be collected in 9-16 hours and a 3rd one in 17-24 hour period.
Step Four:
- No further data will be collected from patient. Study end point is difference in laboratory values between DH and NDH groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Acute Ischemic Stroke Patients that present to University of Minnesota Medical Center and Hennipen County medical Center.
Key inclusion criteria (3 listed)
- Patients with acute Ischemic stroke that present to UMMC ER.
- Age 18-100.
- Subjects are hyperglycemic (defined as blood sugar above 130mg/dl).
Key exclusion criteria (3 listed)
- Blood sugars less than 130mg/dl.
- Age less than 18 or more than 100.
- Difficult blood draw.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention is planned.None is planned | Other | – |
Primary outcome
Difference in the Bio markers of stress between Diabetic and Non diabetic patients that have acute ischemic stroke and hyperglycemia on presentation.
Time frame: 24 hours
Lab values
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Results publication: PubMed 28915969Reshi R, Streib C, Ezzeddine M, Biros M, Miller B, Lakshminarayan K, Anderson D, Ardelt A. Hyperglycemia in acute ischemic stroke: Is it time to re-evaluate our understanding? Med Hypotheses. 2017 Sep;107:78-80. doi: 10.1016/j.mehy.2017.08.017. Epub 2017 Aug 16.
- Hyperglycemia in acute ischemic stroke: Is it time to re-evaluate our understanding?Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rwoof A Reshi, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke and Hyperglycemia, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the Bio markers of stress between Diabetic and Non diabetic patients that have acute ischemic stroke and hyperglycemia on presentation. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03318679, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.