Biomarkers for Postoperative Myocardial Infarction in Car... | NCT02569177

Studies
Biomarkers for Postoperative Myocardial Infarction in Cardiac Surgery.

NCT02569177

Sponsor

UMC Utrecht

Status

Withdrawn

Last Update Posted

Nov 25, 2015Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Myocardial Infarction

Interventions

Not provided

Countries

Not provided

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

Nov 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to lack of funding

Expanded Access Info

Start Date

Nov 2015

Primary Completion Date

Nov 2015Actual

Completion Date

Not provided

First Submitted Date

Sep 28, 2015

First Submission Date that Met QC Criteria

Oct 5, 2015

First Posted Date

Oct 6, 2015Estimated

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

Nov 24, 2015

Last Update Posted Date

Nov 25, 2015Estimated

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

Myocardial infarction and subsequent myocardial injury after cardiac surgery occurs in 7-15% of patients undergoing cardiac surgery and is associated with an increased length of stay, and reduced short- and long-term survival. Cardiac troponin is considered to be a cornerstone in the diagnosis of a myocardial infarction. Heart-type Fatty Acid-Binding Protein (H-FABP) is a new sensitive biomarker for myocardial injury. The effectiveness of using the combination of H-FABP with Troponin to diagnose myocardial injury within 6 hours after the onset of ischemia is well reported. Previous studies in non-surgical patients have associated increased H-FABP with an increased risk of subsequent death and major cardiac events. The prognostic value in cardiac surgery patients has not been studied extensively.

The objective is to estimate the association between biomarkers of myocardial injury and myocardial infarction in patients undergoing cardiac surgery. Myocardial infarction will be established with both a new and very early marker of myocardial injury (Heart-type Fatty Acid Binding Proteins) as well as to a known early marker of such injury (Cardiac troponin).

Detailed Description

Specific aims:

To obtain an estimate of the association between a new very early marker of postoperative myocardial injury H-FABP and postoperative myocardial infarction.
To obtain an estimate of the association between cTn-I and postoperative myocardial infarction.
To obtain an estimate of the correlation between H-FABP elevation and cTn-I elevation in patients undergoing cardiac surgery.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative myocardial infarction	The occurence of postoperative myocardial infarction is imported from the Board Heart interventions Netherlands registry (BHN registry). For every patient undergoing cardiac surgery in the UMCU the cardiothoracic department determines whether the patient had a postoperative myocardial infarction or not and fills out the related information in the BHN registry.	30 days after cardiac surgery

Secondary Outcomes

Measure	Description	Time Frame
Mortality		30-days and 1-year after cardiac surgery
Hospital length of stay		1 year after cardiac surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years or older
isolated coronary artery bypass grafting
isolated valve surgery
combined coronary artery bypass grafting and valve surgery

Exclusion Criteria:

emergency surgery patients
(suspected) sepsis
pulmonary embolism
renal failure (Glomerular filtration rate < 40 ml/min)
off pump cardiac surgery

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

Adult patients undergoing cardiac surgery.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bas van Zaane, Md, PhD	UMC Utrecht	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21304084	Background	Domanski MJ, Mahaffey K, Hasselblad V, Brener SJ, Smith PK, Hillis G, Engoren M, Alexander JH, Levy JH, Chaitman BR, Broderick S, Mack MJ, Pieper KS, Farkouh ME. Association of myocardial enzyme elevation and survival following coronary artery bypass graft surgery. JAMA. 2011 Feb 9;305(6):585-91. doi: 10.1001/jama.2011.99.
18721510

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases