Perioperative Myocardial Ischemia in Isolated Systolic Hypertension

NCT01237652 | Completed

• 1 other identifier: ESA 5971
• Study Type: observational
• Target: 312
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Hypertension; Myocardial Ischemia

Keywords

Isolated Systolic Hypertension; Perioperative Myocardial Ischemia; Perioperative Cardiovascular adverse events

Outcome Measures

Primary Outcomes (1)

• 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.

  48 hours postop

Secondary Outcomes (3)

• Proportion of ISH Patients admitted for non-cardiac surgery

  day of surgery

• Determine the demographics of patients admitted for non-cardiac surgery with Isolated Systolic Hypertension

  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

  1 week

Study Arms (2)

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.

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Perioperative ISH and normotensive presenting for Non-cardiac surgery

You may qualify if:

• 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

You may not qualify if:

• Atrial fibrillation
• Left bundle branch block (LBBB)
• Myocardial infarction \< 3 months
• Decompensated congestive heart failure
• Unstable coronary syndrome
• Dialysis
• Emergency surgery

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Heart and Stroke Foundation of Ontario: collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

Related Publications (1)

• 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.

  PMID: 21347737 DERIVED

MeSH Terms

Conditions

Hypertension; Myocardial Ischemia; Isolated Systolic Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Essential Hypertension

Study Officials

• Ashraf Fayad, MD, FRCPC

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 13, 2010
• First Posted: November 9, 2010
• Study Start: November 1, 2006
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: November 9, 2010

Record last verified: 2010-11

Locations

CA (1)