NCT00423553

Brief Summary

This study will collect heart tissue that is routinely removed and discarded during open-heart surgery. The Cardiology Branch of the NHLBI is conducting a variety of laboratory experiments that require a sample of heart tissue. A segment of tissue is routinely cut out of the right atrial appendage of the heart during open-heart surgery to allow the heart-lung bypass machine to be attached to the heart for protection during surgery. This small tissue sample is not re-attached after the bypass machine is removed, but usually destroyed as medical waste.' People between 18 and 80 years of age who are scheduled to undergo coronary artery bypass surgery or aortic valve replacement surgery may be eligible for this study. Participants donate the right atrial appendage of the heart, which would normally be destroyed after their open-heart surgery. The tissue will be used by NHLBI investigators in studies directed at learning how to make the heart less sensitive to damage from a heart attack. The samples may be used, for example, to evaluate the effectiveness of known therapies, refine treatment approaches, identify potential new therapies, or explore opportunities for disease prevention.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jan 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2007

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 18, 2007

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2007

Completed
Last Updated

July 2, 2017

Status Verified

December 10, 2007

First QC Date

January 17, 2007

Last Update Submit

June 30, 2017

Conditions

Keywords

Nitrite and CytoprotectionIschemic PreconditioningAtrial Trabeculae Contractile FunctionIschemia

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must be 18-80 years of age.
  • Subjects must provide informed, written consent to donate tissue that would otherwise be discarded post-cardiac surgery.
  • Subjects undergoing elective coronary artery bypass surgery and or aortic valve replacement surgery.

You may not qualify if:

  • Subjects currently on oral sulfonylurea therapy for diabetes mellitus
  • Subjects in atrial fibrillation or having had a history of atrial fibrillation in the 2-week period prior to surgery
  • Subjects in clinical right heart failure as evidenced by greater than trace pedal edema, an elevated JVP and or by evidence of hepatic congestion.
  • Subjects unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suburban Hospital

Bethesda, Maryland, 20814, United States

Location

Related Publications (1)

  • Gladwin MT, Shelhamer JH, Schechter AN, Pease-Fye ME, Waclawiw MA, Panza JA, Ognibene FP, Cannon RO 3rd. Role of circulating nitrite and S-nitrosohemoglobin in the regulation of regional blood flow in humans. Proc Natl Acad Sci U S A. 2000 Oct 10;97(21):11482-7. doi: 10.1073/pnas.97.21.11482.

    PMID: 11027349BACKGROUND

MeSH Terms

Conditions

Ischemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

January 17, 2007

First Posted

January 18, 2007

Study Start

January 11, 2007

Study Completion

December 10, 2007

Last Updated

July 2, 2017

Record last verified: 2007-12-10

Locations