Heart DiseasePhase 2MiniMetrxicsNCT00500929
A Clinical Trial in Higher Risk Geriatric Patients Undergoing OHSP
A Phase 2 study testing CMI X-11S in people with Heart Disease, run by Cardiometabolics at 1 site in Canada.
Trial summary
To provide information on parameters needed to design a subsequent Phase III confirmatory trial and to assess the safety and efficacy of the acute use of CMI X-11S in high-risk geriatric patients undergoing open-heart surgical procedures (OHSP) requiring cardio-pulmonary bypass. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Heart Disease
- What is being tested?
- CMI X-11S
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2007to May 2008
- Phase
- Phase 2
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Requirement for open-heart (including emergency) surgical procedures requiring cardio-pulmonary bypass:
- Either:
- Age ≥ 70 to <80 with a Parsonnet Mortality Risk Score of ≥13 (poor risk); OR
- Age ≥ 80
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mini-Metrxics: A Single-Centre, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Clinical Trial of CMI X-11S in Higher Risk Geriatric Patients Undergoing Open-Heart Surgical Procedures (OHSP)
To provide information on parameters needed to design a subsequent Phase III confirmatory trial and to assess the safety and efficacy of the acute use of CMI X-11S in high-risk geriatric patients undergoing open-heart surgical procedures (OHSP) requiring cardio-pulmonary bypass.
- Conditions
- Heart Disease
- Being tested
- CMI X-11S
- Keywords
- OHSP, High risk, Geriatrics
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMI X-11SDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU Time
Measured: 30 to 45 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionApr 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiometabolics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Shaohua Wang, Dr., Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500929
- Sponsor's protocol ID
- CMI X-11S-G-1
- Acronym
- MiniMetrxics
- Status last verified
- Mar 2009
- First submitted
- 12 Jul 2007
- Last updated
- 25 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mini-Metrxics: A Single-Centre, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Clinical Trial of CMI X-11S in Higher Risk Geriatric Patients Undergoing Open-Heart Surgical Procedures (OHSP)
- ClinicalTrials.gov ID
- NCT00500929
- Acronym / sponsor ID
- MiniMetrxics / CMI X-11S-G-1
- Conditions
- Heart Disease
- Keywords
- OHSP, High risk, Geriatrics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- CardiometabolicsIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 13 Jul 2007 (estimated)
- 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 provide information on parameters needed to design a subsequent Phase III confirmatory trial and to assess the safety and efficacy of the acute use of CMI X-11S in high-risk geriatric patients undergoing open-heart surgical procedures (OHSP) requiring cardio-pulmonary bypass.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Requirement for open-heart (including emergency) surgical procedures requiring cardio-pulmonary bypass:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| CMI X-11S | Drug | – |
Primary outcome
ICU Time
Time frame: 30 to 45 days post-surgery
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 25 Mar 2009.
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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.
Shaohua Wang, Dr. principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CMI X-11S in people with Heart Disease, run by Cardiometabolics at 1 site in Canada.
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 4 inclusion and 0 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 25 Mar 2009. 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 Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
ICU Time (time frame: 30 to 45 days post-surgery). 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 25 Mar 2009.