Recruitment

Recruitment Status
Completed
Estimated Enrollment
180

Inclusion Criteria

≥ 18 years of age.
type of surgery either coronary artery bypass grafting (CABG) and/or heart valve surgery (provided that the valve prosthesis used is MRI compatible).
scheduled elective or subacute cardiac surgery with the use of CPB.
≥ 18 years of age.
type of surgery either coronary artery bypass grafting (CABG) and/or heart valve surgery (provided that the valve prosthesis used is MRI compatible).
scheduled elective or subacute cardiac surgery with the use of CPB.

Exclusion Criteria

diagnosis of neurodegenerative disorders such as Alzheimers, Multiple Sclerosis etc.
a history of transitory ischemic attacks (duration of symptoms < 24 hours)
a history of stroke.
...
diagnosis of neurodegenerative disorders such as Alzheimers, Multiple Sclerosis etc.
a history of transitory ischemic attacks (duration of symptoms < 24 hours)
a history of stroke.
a history of reversible ischemic deficits (duration of symptoms 24-72 hours)

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.
type of surgery either coronary artery bypass grafting (CABG) and/or heart valve surgery (provided that the valve prosthesis used is MRI compatible).
scheduled elective or subacute cardiac surgery with the use of CPB.
≥ 18 years of age.
type of surgery either coronary artery bypass grafting (CABG) and/or heart valve surgery (provided that the valve prosthesis used is MRI compatible).
scheduled elective or subacute cardiac surgery with the use of CPB.

Exclusion Criteria

diagnosis of neurodegenerative disorders such as Alzheimers, Multiple Sclerosis etc.
a history of transitory ischemic attacks (duration of symptoms < 24 hours)
a history of stroke.
...
diagnosis of neurodegenerative disorders such as Alzheimers, Multiple Sclerosis etc.
a history of transitory ischemic attacks (duration of symptoms < 24 hours)
a history of stroke.
a history of reversible ischemic deficits (duration of symptoms 24-72 hours)

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