Hypertension Clinical Trial
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.
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.
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.
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