Reduction of Myocardial Infarction by Preconditioning in... | NCT00883363

Studies
Reduction of Myocardial Infarction by Preconditioning in Patients With Ruptured Abdominal Aortic Aneurysm

NCT00883363

Sponsor

Nikolaj Eldrup

Status

Completed

Last Update Posted

Jan 14, 2015Estimated

Enrollment

200Actual

Phase

Not Applicable

Conditions

Abdominal Aortic Aneurysm

Interventions

Precondition

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Apr 15, 2009

First Submission Date that Met QC Criteria

Apr 15, 2009

First Posted Date

Apr 17, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2015

Last Update Posted Date

Jan 14, 2015Estimated

Name	Class
Aarhus University Hospital	OTHER
Aarhus University Hospital Skejby	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Preconditioning in patients treated for elective abdominal aneurysm showed that the rate of perioperative myocardial infarction could be reduced by 80 %(ARR from 27% to 5%). Precondition where performed by 10 minutes of clamping of each iliac arteries before clamping the abdominal aorta. Human studies in cardiac patients have shown promising results with precondition. Instead of clamping arteries they have all performed the procedure by inflating a blood pressure cuff above arterial pressure on a arm.

The investigators want to investigate if preconditioning induced by a blood pressure cuff on a arm can reduce the perioperative rate of myocardial infarction in patients open operated for ruptured abdominal aortic aneurysm.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Precondition	Experimental	Induction of precondition at start of operation on a arm	Procedure: Precondition
Control	No Intervention	No precondition

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Precondition	Procedure	Precondition on a arm in four intervals at start of surgery for ruptured aortic aneurysm	Precondition

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction in myocardial infarction		4 to 5 years

Secondary Outcomes

Measure	Description	Time Frame
Improvement in survival Description on inflammatory response		4 to 5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with ruptured abdominal aortic aneurysm offered surgery
Age > 18 years

Exclusion Criteria:

Technical inoperable

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nikolaj Eldrup, MD PhD	Aarhus University Hospital Skejby	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus university hospital skejby department of cardio thoracic and vascular surgery		Aarhus	Region Midt	8200	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29951634	Derived	Pedersen TF, Budtz-Lilly J, Petersen CN, Hyldgaard J, Schmidt JO, Kroijer R, Gronholdt ML, Eldrup N. Randomized clinical trial of remote ischaemic preconditioning versus no preconditioning in the prevention of perioperative myocardial infarction during open surgery for ruptured abdominal aortic aneurysm. BJS Open. 2018 Mar 26;2(3):112-118. doi: 10.1002/bjs5.55. eCollection 2018 Jun.

ID	Term
D017544	Aortic Aneurysm, Abdominal
D009203	Myocardial Infarction

ID	Term
D001014	Aortic Aneurysm
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases