Recruitment

Recruitment Status
Completed
Estimated Enrollment
180

Inclusion Criterias

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.
≥ 18 years of age.

Exclusion Criterias

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

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.
≥ 18 years of age.

Exclusion Criterias

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

Locations

Copenhagen, DK-2100
Copenhagen, DK-2100

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