HypertensionPROMISENCT01237652
Perioperative Myocardial Ischemia in Isolated Systolic Hypertension
An observational study of Hypertension and Myocardial Ischemia, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
During or after surgery, patients may suffer heart attacks or other heart complications, increasing the hospital stay by 11 days on average and costing an estimated US$20 billion in 1990.Many risk factors have been identified but there are no properly conducted studies to look at Blood pressure (BP) as a risk factor… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Hypertension, Myocardial Ischemia
- How many people
- 312 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2006to Mar 2009
- 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: Perioperative ISH and normotensive presenting for Non-cardiac surgery
Who may be able to join
- Age ≥ 45 years
- ISH or normotensive (as per Patient Recruitment and Informed Consent section)
- Elective non cardiac surgical procedure
- Expected to stay in hospital ≥ 48 hours
- Revised cardiac risk index (RCRI) ≤ 251
Who cannot join
- Atrial fibrillation
- Left bundle branch block (LBBB)
- Myocardial infarction < 3 months
- Decompensated congestive heart failure
- Unstable coronary syndrome
- Dialysis
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Myocardial Ischemia in Isolated Systolic Hypertension (PROMISE)
During or after surgery, patients may suffer heart attacks or other heart complications, increasing the hospital stay by 11 days on average and costing an estimated US$20 billion in 1990.Many risk factors have been identified but there are no properly conducted studies to look at Blood pressure (BP) as a risk factor around the time of surgery. The investigators believe there is a good possibility that systolic BP (SBP) is a risk factor but currently unrecognized. When measuring BP, two numbers are obtained. The upper number is called SBP and a lower number called diastolic BP (DBP). If the numbers are high, this means that the patient has a high BP or hypertension. If the SBP is high while DBP is normal, it is called isolated systolic hypertension (ISH)> ISH is increasingly recognized as a major risk factor for heart problems. The relationship between ISH and heart complications around the time of surgery is poorly understood. Previous studies did not look at such a relationship. Because of that, there are no guidelines for ISH management at the time of surgery. Generally, these patients go through surgery as if they have no increased risk. Studies are starting to show that the bulk of these heart complications happen in patients thought to have low risk factors not yet identified, including ISH.
The investigators believe that the oxygen supply to the heart can be compromised around the time of surgery in ISH patients Chemicals known as stress hormones are secreted around the time of surgery, increasing oxygen needs in the heart and may make the oxygen supply to the heart muscle critical (know as myocardial ischemia). This in turn may result in a heart attack and death. Studies have shown that patients with myocardial ischemia stand a 9-fold increase in odds ratio of suffering a heart attack, worsening of angina, or death.
Read more
This study aims to compare the incidence of myocardial ischemia in patients with ISH and normal BP patients around the time of surgery using a special heart monitor. In addition, the study aims to determine the prevalence of ISH among surgical patients and to document complications like heart attacks, heart failure, stroke and death after surgery.
This research project will be conducted at the Ottawa Hospital by a multi-disciplinary research group (perioperative research group)which includes anesthesiology, cardiology, general surgery and epidemiology. The research group secured HSFO funding for this study.
Read the detailed description
Ethics approval is already obtained. Consented patients will be screened for ISH in the pre-surgical clinic, utilizing BP automated machine. Patients with ISH or normal diastolic function (control group) will be enrolled. During and after surgery, they will be monitored for changes consistent with myocardial ischemia. A special heart monitor, called ambulatory ECG monitor (Holter monitor), will be used to record, document and count any episodes of myocardial ischemia. A designated research coordinator will be assigned to the study for the recruitment, screening, daily tracking and data collection. The heart monitoring for each patient in the study will be reviewed by the research group. Data will be collected and analysed.
This is the first study looking exclusively at ISH as a risk factor around the time of surgery. Studies suggest that investigators may be labelling surgical patients at risk of a heart attack as "low risk" when in fact the bulk of those heart attacks are in patients labeled "low risk". The finding that ISH patients have a higher incidence of myocardial ischemia will provide evidence for the next level of research. If ISH is in fact a risk factor for heart attacks around the time of surgery, the investigators will identify a group of patients in whom the investigators can lower this risk by instituting appropriate management.
- Conditions
- Hypertension, Myocardial Ischemia
- Keywords
- Isolated Systolic Hypertension, Perioperative Myocardial Ischemia, Perioperative Cardiovascular adverse events
- Medical subject headings
- Hypertension, Myocardial Ischemia, Isolated Systolic Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ISH and normotensive | This is a prospective cohort study to compare the incidence of perioperative myocardial ischemia between ISH and normotensive patients admitted for elective non-cardiac surgery. To reduce the number of confounding factors for perioperative myocardial ischemia, RCRI Class I or II patients will be recruited. | |
| ISH, Normotensive | This is a prospective cohort study to compare the incidence of perioperative myocardial ischemia between ISH and normotensive patients admitted for elective non-cardiac surgery. To reduce the number of confounding factors for perioperative myocardial ischemia, RCRI Class I or II patients will be recruited. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of perioperative myocardial ischemia in ISH patients
To determine if the incidence of perioperative myocardial ischemia in ISH patients is triple that of normotensive patients admitted for non-cardiac surgery, as determined by 48-hour ambulatory ST segment ECG monitoring.
Measured: 48 hours postop
Secondary outcomes (3)
Proportion of ISH Patients admitted for non-cardiac surgery
To determine the proportion of patients admitted for non-cardiac surgery with treated and untreated Isolated Systolic Hypertension, normotension, and systemic hypertension with diastolic elevation;
Measured: day of surgery
Determine the demographics of patients admitted for non-cardiac surgery with Isolated Systolic Hypertension
Demographics include age, diabetes, ASA status.
Measured: day of surgery
To determine the overall incidence of perioperative MI, Cardiovascular death, cardiac arrests, or CVA in RCRI Class I or II patients admitted for non cardiac surgery
Outcomes and complications data are collected from the day of surgery until discharge from hospital.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startNov 2006
- Primary completionMar 2009
- Study completionMar 2009
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 HypertensionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario
- Investigators
- Ashraf Fayad, MD, FRCPC, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237652
- Sponsor's protocol ID
- ESA 5971
- Acronym
- PROMISE
- Status last verified
- Nov 2010
- First submitted
- 13 Oct 2010
- Last updated
- 9 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Fayad AA, Yang HY, Ruddy TD, Watters JM, Wells GA. Perioperative myocardial ischemia and isolated systolic hypertension in non-cardiac surgery. Can J Anaesth. 2011 May;58(5):428-35. doi: 10.1007/s12630-011-9477-7. Epub 2011 Feb 24.
PubMed 21347737
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Myocardial Ischemia in Isolated Systolic Hypertension (PROMISE)
- ClinicalTrials.gov ID
- NCT01237652
- Acronym / sponsor ID
- PROMISE / ESA 5971
- Conditions
- Hypertension, Myocardial Ischemia
- Keywords
- Isolated Systolic Hypertension, Perioperative Myocardial Ischemia, Perioperative Cardiovascular adverse events
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario
- Study start
- Nov 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 9 Nov 2010 (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.
During or after surgery, patients may suffer heart attacks or other heart complications, increasing the hospital stay by 11 days on average and costing an estimated US$20 billion in 1990.Many risk factors have been identified but there are no properly conducted studies to look at Blood pressure (BP) as a risk factor around the time of surgery. The investigators believe there is a good possibility that systolic BP (SBP) is a risk factor but currently unrecognized. When measuring BP, two numbers are obtained. The upper number is called SBP and a lower number called diastolic BP (DBP). If the numbers are high, this means that the patient has a high BP or hypertension. If the SBP is high while DBP is normal, it is called isolated systolic hypertension (ISH)> ISH is increasingly recognized as a major risk factor for heart problems. The relationship between ISH and heart complications around the time of surgery is poorly understood. Previous studies did not look at such a relationship. Because of that, there are no guidelines for ISH management at the time of surgery. Generally, these patients go through surgery as if they have no increased risk. Studies are starting to show that the bulk of these heart complications happen in patients thought to have low risk factors not yet identified, including ISH.
The investigators believe that the oxygen supply to the heart can be compromised around the time of surgery in ISH patients Chemicals known as stress hormones are secreted around the time of surgery, increasing oxygen needs in the heart and may make the oxygen supply to the heart muscle critical (know as myocardial ischemia). This in turn may result in a heart attack and death. Studies have shown that patients with myocardial ischemia stand a 9-fold increase in odds ratio of suffering a heart attack, worsening of angina, or death.
This study aims to compare the incidence of myocardial ischemia in patients with ISH and normal BP patients around the time of surgery using a special heart monitor. In addition, the study aims to determine the prevalence of ISH among surgical patients and to document complications like heart attacks, heart failure, stroke and death after surgery.
This research project will be conducted at the Ottawa Hospital by a multi-disciplinary research group (perioperative research group)which includes anesthesiology, cardiology, general surgery and epidemiology. The research group secured HSFO funding for this study.
Detailed description
Ethics approval is already obtained. Consented patients will be screened for ISH in the pre-surgical clinic, utilizing BP automated machine. Patients with ISH or normal diastolic function (control group) will be enrolled. During and after surgery, they will be monitored for changes consistent with myocardial ischemia. A special heart monitor, called ambulatory ECG monitor (Holter monitor), will be used to record, document and count any episodes of myocardial ischemia. A designated research coordinator will be assigned to the study for the recruitment, screening, daily tracking and data collection. The heart monitoring for each patient in the study will be reviewed by the research group. Data will be collected and analysed.
This is the first study looking exclusively at ISH as a risk factor around the time of surgery. Studies suggest that investigators may be labelling surgical patients at risk of a heart attack as "low risk" when in fact the bulk of those heart attacks are in patients labeled "low risk". The finding that ISH patients have a higher incidence of myocardial ischemia will provide evidence for the next level of research. If ISH is in fact a risk factor for heart attacks around the time of surgery, the investigators will identify a group of patients in whom the investigators can lower this risk by instituting appropriate management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ISH and normotensive | – | –This is a prospective cohort study to compare the incidence of perioperative myocardial ischemia between ISH and normotensive patients admitted for elective non-cardiac surgery. To reduce the number of confounding factors for perioperative myocardial ischemia, RCRI Class I or II patients will be recruited. |
| ISH, Normotensive | – | –This is a prospective cohort study to compare the incidence of perioperative myocardial ischemia between ISH and normotensive patients admitted for elective non-cardiac surgery. To reduce the number of confounding factors for perioperative myocardial ischemia, RCRI Class I or II patients will be recruited. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Perioperative ISH and normotensive presenting for Non-cardiac surgery
Key inclusion criteria (5 listed)
- Age ≥ 45 years
- ISH or normotensive (as per Patient Recruitment and Informed Consent section)
- Elective non cardiac surgical procedure
- Expected to stay in hospital ≥ 48 hours
- Revised cardiac risk index (RCRI) ≤ 251
Key exclusion criteria (7 listed)
- Atrial fibrillation
- Left bundle branch block (LBBB)
- Myocardial infarction < 3 months
- Decompensated congestive heart failure
- Unstable coronary syndrome
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
Incidence of perioperative myocardial ischemia in ISH patients
Time frame: 48 hours postop
To determine if the incidence of perioperative myocardial ischemia in ISH patients is triple that of normotensive patients admitted for non-cardiac surgery, as determined by 48-hour ambulatory ST segment ECG monitoring.
3 secondary outcomes
Proportion of ISH Patients admitted for non-cardiac surgery
Time frame: day of surgery
Determine the demographics of patients admitted for non-cardiac surgery with Isolated Systolic Hypertension
Time frame: day of surgery
To determine the overall incidence of perioperative MI, Cardiovascular death, cardiac arrests, or CVA in RCRI Class I or II patients admitted for non cardiac surgery
Time frame: 1 week
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 9 Nov 2010.
- Derived from this study: PubMed 21347737Fayad AA, Yang HY, Ruddy TD, Watters JM, Wells GA. Perioperative myocardial ischemia and isolated systolic hypertension in non-cardiac surgery. Can J Anaesth. 2011 May;58(5):428-35. doi: 10.1007/s12630-011-9477-7. Epub 2011 Feb 24.
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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.
Ashraf Fayad, MD, FRCPC 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 Hypertension and Myocardial Ischemia, 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 5 inclusion and 7 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 9 Nov 2010. 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?
Incidence of perioperative myocardial ischemia in ISH patients (time frame: 48 hours postop). 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 NCT01237652, 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 9 Nov 2010.