Trial record 7 of 10 for:    Open Studies | "Cardiac Output, Low"

Remote Ischemic Preconditioning in High Risk Cardiovascular Surgery Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Queen's University
Sponsor:
Information provided by (Responsible Party):
Darrin Payne, Queen's University
ClinicalTrials.gov Identifier:
NCT01328912
First received: March 31, 2011
Last updated: August 14, 2013
Last verified: August 2013
  Purpose

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
Death
Stroke
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Remote Ischemic Preconditioning in High Risk Cardiovascular Surgery Patients: A Randomized Controlled Trial

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 434
Study Start Date: February 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01328912

Contacts
Contact: Darrin M Payne, MD, MSc, BSc 613 549 6666 ext 2422 payned@kgh.kari.net

Locations
Canada, Ontario
Kingston General Hospital Recruiting
Kingston, Ontario, Canada, K7L 2V7
Contact: Darrin M Payne, MD, MSC, BSc    (613) 549-6666 ext 2422    payned@kgh.kari.net   
Sponsors and Collaborators
Queen's University
Investigators
Principal Investigator: Darrin Payne, MD Queen's University / Kingston General Hospital
  More Information

No publications provided

Responsible Party: Darrin Payne, MD, MSC, BSc, Queen's University
ClinicalTrials.gov Identifier: NCT01328912     History of Changes
Other Study ID Numbers: 6576
Study First Received: March 31, 2011
Last Updated: August 14, 2013
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Cardiac Output, Low
Infarction
Myocardial Infarction
Renal Insufficiency
Stroke
Respiratory Insufficiency
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Kidney Diseases
Urologic Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014