NCT00985049

Brief Summary

Hypothesis: The investigators hypothesize that genetic variants will alter gene expression in response to ischemia during cardiopulmonary bypass. To test this, the investigators will be taking small pieces of heart tissue from patients undergoing heart surgery before and after this period of ischemia. This will be compared to blood gene expression in blood cells and analyzed with the patients' genetic profile. This might allow us to assess the amount of inflammation that occurs when patients are on the heart-lung machine as well as examine the effects genes have on this critical time period.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 28, 2009

Completed
16.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

16.8 years

First QC Date

September 24, 2009

Last Update Submit

August 21, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Differential gene expression

    Immediate

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing cardiac surgery

You may qualify if:

  • Aged greater than 20 years
  • Undergoing aortic valve surgery with or without CABG surgery
  • Receive and apical vent as part of the surgery

You may not qualify if:

  • Will not receive an apical left ventricular vent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (5)

  • Heydarpour M, Ejiofor J, Gilfeather M, Stone G, Gorham J, Seidman CE, Seidman JG, Yammine M, Body SC, Aranki SF, Muehlschlegel JD. Molecular Genetics of Lidocaine-Containing Cardioplegia in the Human Heart During Cardiac Surgery. Ann Thorac Surg. 2018 Nov;106(5):1379-1387. doi: 10.1016/j.athoracsur.2018.06.016. Epub 2018 Jul 17.

  • Saddic LA, Nicoloro SM, Gupta OT, Czech MP, Gorham J, Shernan SK, Seidman CE, Seidman JG, Aranki SF, Body SC, Fitzgibbons TP, Muehlschlegel JD. Joint analysis of left ventricular expression and circulating plasma levels of Omentin after myocardial ischemia. Cardiovasc Diabetol. 2017 Jul 7;16(1):87. doi: 10.1186/s12933-017-0567-x.

  • Saddic LA, Sigurdsson MI, Chang TW, Mazaika E, Heydarpour M, Shernan SK, Seidman CE, Seidman JG, Aranki SF, Body SC, Muehlschlegel JD. The Long Noncoding RNA Landscape of the Ischemic Human Left Ventricle. Circ Cardiovasc Genet. 2017 Jan;10(1):e001534. doi: 10.1161/CIRCGENETICS.116.001534.

  • Sigurdsson MI, Saddic L, Heydarpour M, Chang TW, Shekar P, Aranki S, Couper GS, Shernan SK, Seidman JG, Body SC, Muehlschlegel JD. Allele-specific expression in the human heart and its application to postoperative atrial fibrillation and myocardial ischemia. Genome Med. 2016 Dec 6;8(1):127. doi: 10.1186/s13073-016-0381-1.

  • Saddic LA, Chang TW, Sigurdsson MI, Heydarpour M, Raby BA, Shernan SK, Aranki SF, Body SC, Muehlschlegel JD. Integrated microRNA and mRNA responses to acute human left ventricular ischemia. Physiol Genomics. 2015 Oct;47(10):455-62. doi: 10.1152/physiolgenomics.00049.2015. Epub 2015 Jul 14.

Biospecimen

Retention: SAMPLES WITH DNA

DNA, EDTA , peripheral blood leucocytes, and left ventricle myocardium are all stored in -80C frreezer at BWH.

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Jochen D. Muehlschlegel, MD, MMSc, MBA

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR
  • Sergey Karamnov, MD

    Brigham and Women's Hospital

    STUDY DIRECTOR

Central Study Contacts

Jochen D Muehlschlegel, MD, MMSc, MBA

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anesthesia

Study Record Dates

First Submitted

September 24, 2009

First Posted

September 28, 2009

Study Start

March 1, 2009

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

August 22, 2024

Record last verified: 2024-08

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