Cardiac ComplicationPROSE 3NCT01423136
Remote Electrocardiographic (ECG) ST-Monitoring (PROSE 3)in Post-op Patients
An observational study of Cardiac Complication and Postoperative Complications, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
In moderate to high risk patients, cardiovascular complications after surgery account for almost 60% of death after surgery. This study will randomize 140 patients into routine postop care with Holter monitoring versus routine postop care + remote ST monitoring + Holter monitoring. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Cardiac Complication, Postoperative Complications
- What is being tested?
- Remote ECG monitoring Spacelab SL 1050
- Type of treatment
- Medical device
- How many people
- 89 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2010to Oct 2012
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients under-going non-cardiac Sx with moderate to high risk of postoperative cardiovascular complications
Who may be able to join
- Age ≥ 55 years, undergoing non-cardiac surgery with an expected LOS ≥ 2 days, who fulfills at least one of the six criteria for increased risk:
- History of CAD as defined by any of the following 6 criteria i. history of angina ii. prior myocardial infarction iii. prior positive exercise stress test iv. prior documentation of cardiac ischemia on nuclear stress testing v. prior coronary artery arteriographic evidence of atherosclerotic stenosis > 50% of vessel diameter vi. ECG with pathological Q waves in two contiguous leads
- PVD as defined by any one of the following 3 criteria:
- intermittent claudication (i.e. leg pain on walking that disappears in< 10 minutes on standing) that is known or likely to be due to atherosclerotic disease ii. an ankle/arm systolic BP ratio < 0.90 in either leg at rest iii. angiographic or Doppler study demonstrating >70% stenosis
- History of stroke (i.e. deficit that persisted for at least 1 week after onset) thought due to atherothrombotic disease (i.e. NOT a lacunar stroke, hemorrhagic stroke, nor embolic stroke secondary to atrial fibrillation)
- Hospitalization for CHF within 3 years of randomization
- Undergoing major open vascular surgery
- Any 3 of the following 7 risk factors i. high risk type of surgery (eg. Open Intrathoracic, intraperitoneal, or major orthopedic surgery) ii. any history of congestive heart failure iii. diabetes and currently on oral hypoglycemic agents or insulin iv. preoperative serum creatinine >175 micromol/L v. age > 70 years vi. history of TIA (i.e. that lasted less than 24 hours) vii. urgent / emergent surgery
Who cannot join
- Planned ICU admission; atrial fibrillation; left bundle branch block (LBBB); LVH with strain; pacemaker dependency interfering with ST analysis; hemodialysis; digoxin; CABG or PCI within 5 years without any recurrence of CAD by symptoms or cardiac investigations; surgery with low physiological trespasses such as digit re-implantation, nerve repair, etc.; COPD / asthma requiring bronchodilators within the last 12 months; refusal to transfusions; adverse drug reaction (ADR) to NSAIDS, beta-blockers, Ca-channel blockers, statins, nitrates; prior enrolment in PROSE.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postop Remote ECG ST-Monitoring (PROSE 3)
In moderate to high risk patients, cardiovascular complications after surgery account for almost 60% of death after surgery. This study will randomize 140 patients into routine postop care with Holter monitoring versus routine postop care + remote ST monitoring + Holter monitoring. The response time to electrocardiographic (ECG) ST changes as well as the total ischemia time will be studied.
Read the detailed description
This proposal aims to improve the process and quality of care in the postoperative period by early detection of ischemia and prompt use of accepted therapies in order to prevent postoperative myocardial infarctions (PMI) in patients undergoing non-cardiac surgery. Specifically, it aims to validate the safety and efficacy of wireless remote real-time ECG ST-monitoring in the reduction of the incidence of PMI. It extends two pilot feasibility studies into the postoperative period using wireless remote ST-monitoring for early detection of myocardial ischemia followed by preventative strategies. It is anticipated that this research will improve postoperative care by adopting generalizable and practical strategies.
- Conditions
- Cardiac Complication, Postoperative Complications
- Being tested
- Remote ECG monitoring Spacelab SL 1050
- Keywords
- Patients undergoing non-cardiac Surgery
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ECG monitoring Spacelab SL 1050Device
If ischemia noted, Sx will be notified and currently accepted treatments of myocardial ischemia will be recommended.
| Study group | Role | What they receive |
|---|---|---|
| Routine postop care + Holter Monitoring | With sham remote ECG ST Monitoring | |
| Routine postop care + Holter + remote ECG monitoring | Not described Receives: Device: Remote ECG monitoring Spacelab SL 1050 |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of postop myocardial ischemia
To determine if the duration of postoperative myocardial ischemia during real-time wireless management of ischemic ECG ST changes is half that of standard postop care, as determined by 48-hour ambulatory ECG monitoring
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2011 (estimated)
- Study startOct 2010
- Primary completionMar 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ComplicationStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The Ottawa Hospital Academic Medical Association
- Responsible party
- Sponsor
- Investigators
- H. Yang, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423136
- Sponsor's protocol ID
- 2009521-01H
- Acronym
- PROSE 3
- Status last verified
- May 2014
- First submitted
- 28 Mar 2011
- Last updated
- 2 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postop Remote ECG ST-Monitoring (PROSE 3)
- ClinicalTrials.gov ID
- NCT01423136
- Acronym / sponsor ID
- PROSE 3 / 2009521-01H
- Conditions
- Cardiac Complication, Postoperative Complications
- Keywords
- Patients undergoing non-cardiac Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- The Ottawa Hospital Academic Medical Association
- Study start
- Oct 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 25 Aug 2011 (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.
In moderate to high risk patients, cardiovascular complications after surgery account for almost 60% of death after surgery. This study will randomize 140 patients into routine postop care with Holter monitoring versus routine postop care + remote ST monitoring + Holter monitoring. The response time to electrocardiographic (ECG) ST changes as well as the total ischemia time will be studied.
Detailed description
This proposal aims to improve the process and quality of care in the postoperative period by early detection of ischemia and prompt use of accepted therapies in order to prevent postoperative myocardial infarctions (PMI) in patients undergoing non-cardiac surgery. Specifically, it aims to validate the safety and efficacy of wireless remote real-time ECG ST-monitoring in the reduction of the incidence of PMI. It extends two pilot feasibility studies into the postoperative period using wireless remote ST-monitoring for early detection of myocardial ischemia followed by preventative strategies. It is anticipated that this research will improve postoperative care by adopting generalizable and practical strategies.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine postop care + Holter Monitoring | – | –With sham remote ECG ST Monitoring |
| Routine postop care + Holter + remote ECG monitoring | – | Device: Remote ECG monitoring Spacelab SL 1050 |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients under-going non-cardiac Sx with moderate to high risk of postoperative cardiovascular complications
Key inclusion criteria (8 listed)
- Age ≥ 55 years, undergoing non-cardiac surgery with an expected LOS ≥ 2 days, who fulfills at least one of the six criteria for increased risk:
Key exclusion criteria (1 listed)
- Planned ICU admission; atrial fibrillation; left bundle branch block (LBBB); LVH with strain; pacemaker dependency interfering with ST analysis; hemodialysis; digoxin; CABG or PCI within 5 years without any recurrence of CAD by symptoms or cardiac investigations; surgery with low physiological trespasses such as digit re-implantation, nerve repair, etc.; COPD / asthma requiring bronchodilators within the last 12 months; refusal to transfusions; adverse drug reaction (ADR) to NSAIDS, beta-blockers, Ca-channel blockers, statins, nitrates; prior enrolment in PROSE.
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 |
|---|---|---|
| Remote ECG monitoring Spacelab SL 1050If ischemia noted, Sx will be notified and currently accepted treatments of myocardial ischemia will be recommended. | Device | Routine postop care + Holter + remote ECG monitoring |
Primary outcome
duration of postop myocardial ischemia
Time frame: 48 hours
To determine if the duration of postoperative myocardial ischemia during real-time wireless management of ischemic ECG ST changes is half that of standard postop care, as determined by 48-hour ambulatory ECG monitoring
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 2 Jun 2014.
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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.
H. Yang, MD principal investigator
Ottawa Hospital Research Institute
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 Postoperative Complications, 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 8 inclusion and 1 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 2 Jun 2014. 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?
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?
duration of postop myocardial ischemia (time frame: 48 hours). 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 2 Jun 2014.