Endothelial Dysfunction As A Predictor Of Perioperative Outcome

NCT00384683 | Completed

• 1 other identifier: 2003-0434
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn whether the inability of certain blood vessel cells (endothelial cells) to function properly may help researchers to predict who is at risk for complications after surgery and whether this dysfunction contributes to complications after surgery. This study will use a blood test to quantify the number of cells that are destined to become endothelial cells.

Conditions

Endothelial Dysfunction

Keywords

Endothelial Dysfunction; Endothelial Cells; Perioperative Outcome; Blood Sample

Outcome Measures

Primary Outcomes (1)

• Number of Patient Major Pulmonary Events (MPE)

  Baseline (entry in study) to end of study (estimated 1 year post-operative)

Secondary Outcomes (1)

• Patient's Duration of intensive care unit / hospital length of stay

  Baseline to final day of hospitalization

Study Arms (1)

Endothelial Dysfunction

Participants are scheduled for major chest (lung or esophagus) surgery or are a healthy volunteer. A blood test will quantify the number of cells that are destined to become endothelial cells.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants is scheduled to have major chest (lung or esophagus) surgery or is a healthy volunteer.

You may qualify if:

• Patients scheduled for major thoracic surgery (lobectomy, pneumonectomy, esophagectomy).
• Patients 18 years of age or older.
• Patients who have signed the consent form to participate in the study.
• Patients must have been evaluated in the Preanesthesia Clinic or by a staff Anesthesiologist preoperatively.
• All laboratory and diagnostic evaluations required or used to evaluate the patient in the Preanesthesia Clinic must be completed. All patients must be approved for surgery by the standards of the Preanesthesia Clinic.

You may not qualify if:

• Refusal to participate in the study.
• Patient is under age 18.
• Patient is unwilling to sign consent.
• Patient is unable to exercise (bedridden or wheel chair bound).
• Patient is enrolled in another study deemed by the investigator to affect oxygen metabolic efficiency and not presently the standard of care at MDACC.
• Any patient whose condition is deemed unsatisfactory for surgery after the preanesthetic evaluation.
• Surgery canceled for any reason. The patient may reenter the study if surgery is rescheduled.
• Patient has had a myocardial infarction within 3 months of visiting the Preanesthesia Clinic or presents with new or unstable angina.
• Patient has a history of cerebrovascular accident or transient ischemic attacks within 3 months of visiting the Preanesthesia Clinic.
• Patient has a history of pulmonary embolic event within 3 months of visiting the Preanesthesia Clinic.
• Patient known to have acute or chronic deep vein thrombosis.
• Pregnant patients.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center Official Web Site

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples collected to measure number of circulating blood cells that become endothelial cells. During surgery a small sample of lung tissue collected, if available.

Study Officials

• Reza-John Mehran, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2006
• First Posted: October 6, 2006
• Study Start: March 1, 2006
• Primary Completion: June 5, 2019
• Study Completion: June 5, 2019
• Last Updated: September 24, 2019

Record last verified: 2019-09

Locations

US (1)