Perfusion Pressure Cerebral Infarction Trial (PPCI)
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 180
Inclusion Criteria
- ≥ 18 years of age.
- scheduled elective or subacute cardiac surgery with the use of CPB.
- type of surgery either coronary artery bypass grafting (CABG) and/or heart valve surgery (provided that the valve prosthesis used is MRI compatible).
- ≥ 18 years of age.
- scheduled elective or subacute cardiac surgery with the use of CPB.
- type of surgery either coronary artery bypass grafting (CABG) and/or heart valve surgery (provided that the valve prosthesis used is MRI compatible).
Exclusion Criteria
- a history of stroke.
- a history of transitory ischemic attacks (duration of symptoms < 24 hours)
- a history of reversible ischemic deficits (duration of symptoms 24-72 hours)
- ...
- a history of stroke.
- a history of transitory ischemic attacks (duration of symptoms < 24 hours)
- a history of reversible ischemic deficits (duration of symptoms 24-72 hours)
- diagnosis of neurodegenerative disorders such as Alzheimers, Multiple Sclerosis etc.
Summary
- Conditions
- Embolic Stroke
- Postoperative Cognitive Dysfunction
- Type
- Interventional
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
TRIAL DESIGN The PPCI trial is a randomized, controlled, outcomes assessor and patient blinded, single-center superiority trial with two parallel groups in a 1:1 allocation ratio. The randomization will be stratified according to age (stratum 1 < 70 years; stratum 2 ≥ 70 years) and type of surgery (...
TRIAL DESIGN The PPCI trial is a randomized, controlled, outcomes assessor and patient blinded, single-center superiority trial with two parallel groups in a 1:1 allocation ratio. The randomization will be stratified according to age (stratum 1 < 70 years; stratum 2 ≥ 70 years) and type of surgery (stratum 1 - surgery involving the aortic and/or mitral valve; stratum 2 - surgery not involving these valves).
Inclusion Criteria
- ≥ 18 years of age.
- scheduled elective or subacute cardiac surgery with the use of CPB.
- type of surgery either coronary artery bypass grafting (CABG) and/or heart valve surgery (provided that the valve prosthesis used is MRI compatible).
- ≥ 18 years of age.
- scheduled elective or subacute cardiac surgery with the use of CPB.
- type of surgery either coronary artery bypass grafting (CABG) and/or heart valve surgery (provided that the valve prosthesis used is MRI compatible).
Exclusion Criteria
- a history of stroke.
- a history of transitory ischemic attacks (duration of symptoms < 24 hours)
- a history of reversible ischemic deficits (duration of symptoms 24-72 hours)
- ...
- a history of stroke.
- a history of transitory ischemic attacks (duration of symptoms < 24 hours)
- a history of reversible ischemic deficits (duration of symptoms 24-72 hours)
- diagnosis of neurodegenerative disorders such as Alzheimers, Multiple Sclerosis etc.
Tracking Information
- NCT #
- NCT02185885
- Collaborators
- Danish Heart Foundation
- Investigators
- Principal Investigator: Jens C. Nilsson, MD, PhD Rigshospitalet, Denmark Study Chair: Hanne B. Ravn, MD, DMSc Rigshospitalet, Denmark
- Jens C. Nilsson, MD, PhD Rigshospitalet, Denmark Study Chair: Hanne B. Ravn, MD, DMSc Rigshospitalet, Denmark
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