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Remote Ischemic Preconditioning in High Risk Cardiovascular Surgery Patients

This study has been completed.
Information provided by (Responsible Party):
Dr. Darrin Payne, Queen's University Identifier:
First received: March 31, 2011
Last updated: February 4, 2016
Last verified: February 2016

Remote ischemic preconditioning (RIPC) occurs when a tissue (ex. heart) becomes less vulnerable to an ischemic insult if a remote tissue (ex. arm) has had previous exposure to a period of ischemia and reperfusion. A beneficial effect of RIPC has been demonstrated in several randomized studies in patients undergoing cardiac and vascular surgery, as well as interventional cardiac procedures such as angioplasty. They have shown improvements in cardiac, renal, neurologic and respiratory function. Most have focused on surrogate outcomes, such as biochemical markers of cardiac and renal function in low-risk patients. No trials have investigated only high-risk patients or been designed to detect clinical outcomes.

This study is a randomized-controlled trial powered to detect clinical events in a high-risk cohort undergoing cardiovascular surgery. Patients will be randomized to RIPC (exposed to cycles of inflation of a blood pressure cuff on the upper arm prior to undergoing surgery) or control (no ischemic stimulus).

The investigators hypothesize this population will demonstrate lower rates of adverse ischemic events. The investigators also intend to sample biochemical markers to better elucidate the mechanism of RIPC and generate hypotheses for future studies and interventions. Post-operatively the investigators will monitor for adverse clinical outcomes including cardiac, renal, pulmonary and neurologic injury.

RIPC is simple, inexpensive and easily reproducible and there have been no reports of adverse consequences. Post-operative ischemic events such as stroke, myocardial infarction, cardiac, renal and respiratory failure affect patient survival and quality of life, and represent a sizeable financial burden to health care. If beneficial effects of RIPC are demonstrated, it will be widely applicable to the entire population of cardiac and vascular patients resulting in a widely-implemented change in practice.

Condition Intervention Phase
Low Cardiac Output Syndrome
Myocardial Infarction
Renal Failure
Pulmonary Failure
Other: Remote ischemic preconditioning stimulus
Other: control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Remote Ischemic Preconditioning in High Risk Cardiovascular Surgery Patients: A Randomized Controlled Trial

Further study details as provided by Queen's University:

Primary Outcome Measures:
  • The primary outcome measure will be a composite of clinical MACE (Multiple Adverse Cardiovascular Events), incorporating all-cause mortality, myocardial infarction, stroke, respiratory failure, acute renal failure and low cardiac output syndrome [ Time Frame: 30 days ]

Enrollment: 429
Study Start Date: February 2012
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Remote ischemic preconditioning stimulus Other: Remote ischemic preconditioning stimulus
The intervention will consist of 3 cycles of 5 minutes of upper limb ischemia. The RIPC stimulus will be performed using a blood pressure cuff placed on the upper arm inflated above systemic pressure to 200 mmHg for 5 minutes, then deflated for 5 minutes. Ischemia will be assured with the use of a saturation probe on the digit of the involved arm.
Placebo Comparator: Control Other: control
These patients are randomized to placebo, thus they will no undergo the RIPC stimulus.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Undergoing either cardiac or vascular surgical procedures and are deemed to be at increased risk of suffering adverse ischemia-related events (judged by pre-operative evidence of clinical ischemic conditions, pre-operative screening indicating cardiovascular disease or undergoing higher-risk surgery).

Exclusion Criteria:

  • Will not include emergency cases, patients with known vascular disease (ex. arterial occlusive disease, arterio-venous shunts) or neurologic disease affecting the upper limb and patients unable to give informed consent.
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Please refer to this study by its identifier: NCT01328912

Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Sponsors and Collaborators
Queen's University
Principal Investigator: Darrin Payne, MD Queen's University / Kingston General Hospital
  More Information

Responsible Party: Dr. Darrin Payne, MD, MSC, BSc, Queen's University Identifier: NCT01328912     History of Changes
Other Study ID Numbers: 6576
Study First Received: March 31, 2011
Last Updated: February 4, 2016

Keywords provided by Queen's University:
ischemic preconditioning
cardiac surgery
vascular surgery

Additional relevant MeSH terms:
Myocardial Infarction
Renal Insufficiency
Cardiac Output, Low
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Kidney Diseases
Urologic Diseases
Signs and Symptoms processed this record on April 28, 2017