NCT00614107

Brief Summary

A form of irregular heart rate called, Atrial Fibrillation (AF) is a major clinical problem. It afflicts about 2 million Americans and is the single largest heart related cause of stroke. However, despite 120 years of speculation and research, the mechanisms that cause AF are poorly understood. Acute AF is also the most common irregular heart rate after open-heart surgery in patients. This is seen in as many as 30% of such patients and often results in a longer hospital stay. In this study we would like to study the pattern of atrial fibrosis (scar tissue in the heart) and an associated blood marker (a protein called pro-collagen-1) in those patients concurrently having open heart surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2008

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 1, 2008

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 13, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

October 20, 2021

Status Verified

January 1, 2008

Enrollment Period

1 year

First QC Date

January 30, 2008

Last Update Submit

October 19, 2021

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation post open heart surgery

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any person over 18 years having an elective valve, CABG or combination procedure

You may qualify if:

  • years of age, Male or Female
  • Able to provide consent
  • Cardiac surgery, CABG of Valve replacement or repair.

You may not qualify if:

  • If AF terminates within 1 hour of initiation.
  • If the patients and/or their family or the primary caregiver choose to be excluded from the study anytime, even after the initial 24-hour period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue sample for the right and left sid eof the heart.

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 30, 2008

First Posted

February 13, 2008

Study Start

January 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

October 20, 2021

Record last verified: 2008-01

Locations

US(1)