Cardiac ComplicationCOSMICNCT05762601
Cellular precOnditioning for Post-Surgical Myocardial Ischemic Complications - Observational Study
An observational study of Cardiac Complication and Myocardial Infarction, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
The goal of this observational study is to collect health data on people who are at high risk of having heart complications and are having a surgery that is not on the heart. The main questions it aims to answer are: Is this study feasible in terms of recruiting enough people to participate in this study? How often do… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Cardiac Complication, Myocardial Infarction, Myocardial Ischemia
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 15 Feb 2023to Sep 2025
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited from the Ottawa Hospital
Who may be able to join
- A participant must meet all 5 inclusion criteria to be eligible:
- Referred for elective intermediate to high risk noncardiac surgery as defined by the American Heart Association guidelines (e.g., intrathoracic, open intraabdominal, or open vascular surgery)
- 45 years of age or older
- Revised cardiac risk index ≥ 2
- NT-proBNP level of ≥ 200 pg/mL
- Able to provide informed consent
Who cannot join
- Experience an acute coronary syndrome, myocardial infarction, heart failure, or stroke within preceding 3 months
- Coronary revascularization anticipated during the study period
- Severe mitral/aortic valve stenosis
- Evidence of clinically significant arrhythmia in last three months.
- Major surgical procedure in previous 3 months
- History of malignancy requiring surgery, chemotherapy, immunotherapy, or radiation within previous 5 years
Show all 10Show fewer
- Ongoing malignancy requiring surgical resection
- Women who are pregnant, breastfeeding, or of childbearing potential who are unable to use a medically acceptable form of contraception throughout the study
- Received any experimental cell therapy previously
- Unable to provide written informed consent
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Manoj M Lalu, MD, PhD
About this study
The goal of this observational study is to collect health data on people who are at high risk of having heart complications and are having a surgery that is not on the heart. The main questions it aims to answer are:
- Is this study feasible in terms of recruiting enough people to participate in this study?
- How often do heart complications happen in people who are at high risk of heart complications and are having a surgery that is not on the heart?
Read more
Participants will have their usual care and will also be asked to:
- Have extra bloodwork done
- Complete some surveys
- Have two echocardiograms (ultrasounds of the heart)
- Continue to follow-up with the research team for one year after their surgery
Researchers will compare how often heart complications occur in this high risk population to a future study where participants will receive stem cells before their surgery.
Read the detailed description
This observational trial protocol is to collect baseline health data from participants undergoing intermediate to high-risk surgery and at high risk of developing perioperative myocardial ischemic complications for an upcoming Phase 1 trial that determines the feasibility of intravenous delivery of umbilical cord-derived (UC) mesenchymal stromal cells (MSCs) in the same patient population. Participants enrolled in this protocol, however, will not receive cell product; they will receive standard of care and serve as a lead in control group for the interventional study.
- Keywords
- Myocardial injury after noncardiac surgery, Perioperative myocardial infarction
- Medical subject headings
- Myocardial Infarction, Myocardial Ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Participant Recruitment
Our primary outcome is the feasibility of participant recruitment. This will be determined by measurements of recruitment efficiency: 1) proportion of potentially eligible participants that are successfully screened; 2) proportion of participants successfully screened who do not enroll (reason for failure to enroll will be recorded).
Measured: 1 year
Baseline Frequency of adverse events and serious adverse events
To determine the baseline frequency of adverse events and serious adverse events in this high risk population
Measured: 1 year
Secondary outcomes (1)
Quality of life of participants
The EQ-5D-5L questionnaire will be used. This questionnaire measures quality of life using five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start15 Feb 2023
- Primary completionSep 2024 (estimated)
- Study completionSep 2025 (estimated)
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 Cardiac ComplicationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Anesthesiologists' Society, The Ottawa Hospital Academic Medical Association
- Responsible party
- Sponsor
- Investigators
- Manoj M Lalu, MD, PhD, Principal investigator, The Ottawa Hospital Research Institute, The Ottawa Hospital, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762601
- Sponsor's protocol ID
- 20220330-01H
- Acronym
- COSMIC
- Status last verified
- Apr 2024
- First submitted
- 8 Feb 2023
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lalu MM, Mazzarello S, Zlepnig J, Dong YYR, Montroy J, McIntyre L, Devereaux PJ, Stewart DJ, David Mazer C, Barron CC, McIsaac DI, Fergusson DA. Safety and Efficacy of Adult Stem Cell Therapy for Acute Myocardial Infarction and Ischemic Heart Failure (SafeCell Heart): A Systematic Review and Meta-Analysis. Stem Cells Transl Med. 2018 Dec;7(12):857-866. doi: 10.1002/sctm.18-0120. Epub 2018 Sep 26.
PubMed 30255989
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cellular precOnditioning for Post-Surgical Myocardial Ischemic Complications - Observational Study
- ClinicalTrials.gov ID
- NCT05762601
- Acronym / sponsor ID
- COSMIC / 20220330-01H
- Keywords
- Myocardial injury after noncardiac surgery, Perioperative myocardial infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Anesthesiologists' Society, The Ottawa Hospital Academic Medical Association
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 9 Mar 2023 (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.
The goal of this observational study is to collect health data on people who are at high risk of having heart complications and are having a surgery that is not on the heart. The main questions it aims to answer are:
- Is this study feasible in terms of recruiting enough people to participate in this study?
- How often do heart complications happen in people who are at high risk of heart complications and are having a surgery that is not on the heart?
Participants will have their usual care and will also be asked to:
- Have extra bloodwork done
- Complete some surveys
- Have two echocardiograms (ultrasounds of the heart)
- Continue to follow-up with the research team for one year after their surgery
Researchers will compare how often heart complications occur in this high risk population to a future study where participants will receive stem cells before their surgery.
Detailed description
This observational trial protocol is to collect baseline health data from participants undergoing intermediate to high-risk surgery and at high risk of developing perioperative myocardial ischemic complications for an upcoming Phase 1 trial that determines the feasibility of intravenous delivery of umbilical cord-derived (UC) mesenchymal stromal cells (MSCs) in the same patient population. Participants enrolled in this protocol, however, will not receive cell product; they will receive standard of care and serve as a lead in control group for the interventional study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from the Ottawa Hospital
Key inclusion criteria (6 listed)
- Referred for elective intermediate to high risk noncardiac surgery as defined by the American Heart Association guidelines (e.g., intrathoracic, open intraabdominal, or open vascular surgery)
- 45 years of age or older
- Revised cardiac risk index ≥ 2
- NT-proBNP level of ≥ 200 pg/mL
- Able to provide informed consent
Key exclusion criteria (10 listed)
- Experience an acute coronary syndrome, myocardial infarction, heart failure, or stroke within preceding 3 months
- Coronary revascularization anticipated during the study period
- Severe mitral/aortic valve stenosis
- Evidence of clinically significant arrhythmia in last three months.
- Major surgical procedure in previous 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility of Participant Recruitment
Time frame: 1 year
Our primary outcome is the feasibility of participant recruitment. This will be determined by measurements of recruitment efficiency: 1) proportion of potentially eligible participants that are successfully screened; 2) proportion of participants successfully screened who do not enroll (reason for failure to enroll will be recorded).
Baseline Frequency of adverse events and serious adverse events
Time frame: 1 year
To determine the baseline frequency of adverse events and serious adverse events in this high risk population
1 secondary outcome
Quality of life of participants
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Background: PubMed 30255989Lalu MM, Mazzarello S, Zlepnig J, Dong YYR, Montroy J, McIntyre L, Devereaux PJ, Stewart DJ, David Mazer C, Barron CC, McIsaac DI, Fergusson DA. Safety and Efficacy of Adult Stem Cell Therapy for Acute Myocardial Infarction and Ischemic Heart Failure (SafeCell Heart): A Systematic Review and Meta-Analysis. Stem Cells Transl Med. 2018 Dec;7(12):857-866. doi: 10.1002/sctm.18-0120. Epub 2018 Sep 26.
- Individual participant dataSharing planned: Undecided
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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.
Manoj M Lalu, MD, PhD principal investigator
The Ottawa Hospital Research Institute, The Ottawa Hospital, University of Ottawa
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 Cardiac Complication and Myocardial Infarction, run by Ottawa Hospital Research Institute 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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 3 Apr 2024. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meredith Conboy, MSc (613-737-8899 ext. 73800, mconboy@ohri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Participant Recruitment (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT05762601, 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 3 Apr 2024.