Acute Coronary SyndromesCOMGAMINCT03107806
Monitoring Glucose Levels in Patients With Myocardial Infarction
A study testing OptiScanner® in people with Acute Coronary Syndromes and Hyperglycemia, run by Lars Ryden at 1 site in Sweden.
Trial summary
To evaluate the OptiScanner® for continuous glucose monitoring as a tool to optimize glucose levels in patients hospitalized for acute coronary syndromes Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndromes, Hyperglycemia, Hypoglycemia
- What is being tested?
- OptiScanner®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2013to Jan 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute coronary syndrome according to the joint recommendations by the European Society of Cardiology (48, 49)
- Signed written informed consent consistent with Helsinki declaration and local legislations prior to participation in the trial.
Who cannot join
- <18 years old.
- Congestive heart failure.
- Patients who, in the opinion of the investigator, will have difficulties to comply with the protocol (examples: alcohol or drug abuse, psychiatric disorder).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COMGAMI Continuous Monitoring of Glucose in Acute Myocardial Infarction
To evaluate the OptiScanner® for continuous glucose monitoring as a tool to optimize glucose levels in patients hospitalized for acute coronary syndromes
Read the detailed description
Methodology Part a) Explorative Part b) Randomised, parallel-group design
- Conditions
- Acute Coronary Syndromes, Hyperglycemia, Hypoglycemia
- Being tested
- OptiScanner®
- Keywords
- acute coronary syndromes, hyperglycemia, hypoglycemia, continuous glucose monitoring
- Medical subject headings
- Acute Coronary Syndrome, Hyperglycemia, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OptiScanner®Device
- Glucose monitoring by OptiScanner® for 48 h
- Glucose lowering intervention (insulin) guided by OptiScanner®
| Study group | Role | What they receive |
|---|---|---|
| Glucose monitoring by OptiScanner® | Other | Glucose monitoring and intervention guided by OptiScanner® Receives: Device: OptiScanner® |
| Blinded continuous glucose monitoring | Other | Blinded continuous glucose monitoring by OptiScanner® and glucose lowering intervention guided by routine glucose measurements Receives: Device: OptiScanner® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of glucose values derived by the new equipment vs. standard lab recordings
The above specified part of the study is ongoing. Preliminary data confirms accuracy of recorded glucose values but there is a problem with venous access over the intended time of 48 hours. A new type of venous access will be tested and ethics approval has just been accomplished.
Measured: During the first part of the study, up to 6 months
Secondary outcomes (5)
Glucose variability
Glucose variability
Measured: Hospitalization, through study completion, an average of 1 year
Number of episodes of Hypoglycemia
No of episodes of hypoglycaemia defined as glucose <3.0 mmol/L with or without symptoms.
Measured: Hospitalization, through study completion, an average of 1 year
Number of episodes of Hyperglycemia
No of episodes of hyperglycemia >12 mmol/L
Measured: Hospitalization, through study completion, an average of 1 year
Work load in nursing staff
Work load in nursing staff, questionnaire
Measured: Hospitalization, through study completion, an average of 1 year
Time in targeted glucose values
Targets for plasma glucose are defined and the personnel will have support of the new equipment allowing continuous monitoring of glucose levels when adjusting glucose lowering therapy. This will be compared to monitoring with standard, intermittent glucose measuring.
Measured: Next step after the completion of the first and ongoing part. through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study startApr 2013
- Primary completionJan 2018
- Study completionJan 2018
Why it stopped: Blood withdrawal problems despite use of different catheters.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lars Ryden
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Swedish Heart Lung Foundation
- Responsible party
- Sponsor-investigator, Lars Ryden, Karolinska Institutet
- Investigators
- Camilla Hage, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107806
- Sponsor's protocol ID
- 2011/1446-31/1
- Acronym
- COMGAMI
- Status last verified
- Apr 2017
- First submitted
- 16 Apr 2013
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMGAMI Continuous Monitoring of Glucose in Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT03107806
- Acronym / sponsor ID
- COMGAMI / 2011/1446-31/1
- Conditions
- Acute Coronary Syndromes, Hyperglycemia, Hypoglycemia
- Keywords
- acute coronary syndromes, hyperglycemia, hypoglycemia, continuous glucose monitoring
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Blood withdrawal problems despite use of different catheters.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Lars RydenUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Swedish Heart Lung Foundation
- Study start
- Apr 2013 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 11 Apr 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.
To evaluate the OptiScanner® for continuous glucose monitoring as a tool to optimize glucose levels in patients hospitalized for acute coronary syndromes
Detailed description
Methodology Part a) Explorative Part b) Randomised, parallel-group design
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucose monitoring by OptiScanner® | Other | Device: OptiScanner®Glucose monitoring and intervention guided by OptiScanner® |
| Blinded continuous glucose monitoring | Other | Device: OptiScanner®Blinded continuous glucose monitoring by OptiScanner® and glucose lowering intervention guided by routine glucose measurements |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute coronary syndrome according to the joint recommendations by the European Society of Cardiology (48, 49)
- Signed written informed consent consistent with Helsinki declaration and local legislations prior to participation in the trial.
Key exclusion criteria (3 listed)
- <18 years old.
- Congestive heart failure.
- Patients who, in the opinion of the investigator, will have difficulties to comply with the protocol (examples: alcohol or drug abuse, psychiatric disorder).
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 |
|---|---|---|
| OptiScanner®1. Glucose monitoring by OptiScanner® for 48 h 2. Glucose lowering intervention (insulin) guided by OptiScanner® | Device | Blinded continuous glucose monitoring, Glucose monitoring by OptiScanner® |
Primary outcome
Accuracy of glucose values derived by the new equipment vs. standard lab recordings
Time frame: During the first part of the study, up to 6 months
The above specified part of the study is ongoing. Preliminary data confirms accuracy of recorded glucose values but there is a problem with venous access over the intended time of 48 hours. A new type of venous access will be tested and ethics approval has just been accomplished.
5 secondary outcomes
Glucose variability
Time frame: Hospitalization, through study completion, an average of 1 year
Number of episodes of Hypoglycemia
Time frame: Hospitalization, through study completion, an average of 1 year
Number of episodes of Hyperglycemia
Time frame: Hospitalization, through study completion, an average of 1 year
Work load in nursing staff
Time frame: Hospitalization, through study completion, an average of 1 year
Time in targeted glucose values
Time frame: Next step after the completion of the first and ongoing part. through study completion, an average of 1 year
Results and safety
The study was stopped early (reason given: Blood withdrawal problems despite use of different catheters.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
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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.
Camilla Hage, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OptiScanner® in people with Acute Coronary Syndromes and Hyperglycemia, run by Lars Ryden at 1 site in Sweden.
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 2 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: stopped early, as of the sponsor's last update on 15 Aug 2019. 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 Sweden. 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 was stopped early (reason given: Blood withdrawal problems despite use of different catheters.). Results are not available in the source record.
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?
Accuracy of glucose values derived by the new equipment vs. standard lab recordings (time frame: During the first part of the study, up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2019.