MDACC Study Summary 2003-0434

Study Summary
No. 2003-0434:.......Gastrointestinal; Lung......Reza J. Mehran......Thoracic & Cardiovascular

Study Summary Title



Study Summary Number:	2003-0434

Study Title:	Endothelial Dysfunction As A Predictor Of Perioperative Outcome In Major Thoracic Surgery - An Observational Study

Physician

New Patient Referral



Name:	Reza J. Mehran	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Thoracic & Cardiovascular	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-4530 Contact us about clinical trials

General Information



Disease Group:	Gastrointestinal Lung	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	No return visits required.

Treatment Agents:	None	Home Care:	No additional home care required.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	This observational study will not increase the length of stay or the frequency of hospitilization.

Description/
Intervention:

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.

Study Objectives / Outcomes

The primary objective is to conduct a prospective observational pilot study investigating preoperative endothelial dysfunction as a predictor of adverse perioperative outcome following major thoracic surgery. Preoperative endothelial function will be assessed using i) high-resolution ultrasonography to measure brachial artery flow-mediated dilation (FMD) - an endothelial-dependent measure and ii) VENDYS (Endothelix, Inc.) thermographic measurement and iii) measures of circulating endothelial progenitor cells. Flow cytometry, a quantitative real-time reverse transcriptase-polymerase chain reaction (RT-PCR) and nucleic acid sequence-based amplification method (NASBA) technique for CD133 will be used to quantify circulating endothelial progenitor cells (EPC) in peripheral-blood. The rationale for including the RT-PCR and NASBA techniques is that this will provide definitive comparisons of two cellular based methods (flow cytometry and colony forming assays) to NASBA and RT-PCR techniques, with the latter techniques being more accesible as point of care tests. These measures will be correlated with cardiopulmonary testing in lobectomy/pneumonectomy and esophagectomy patients and perioperative outcome parameters, namely incidence of adverse cardiopulmonary events as the primary endpoint and duration of intensive care unit / hospital length of stay, and mortality (in hospital, 30 day, and 1 year post-operative) as secondary endpoints.

Study Status Information



Study Activation / Registration Date:	03/29/2006

IRB Review and Approval Date:	06/04/2003

Study Type:	Not Applicable

Recruitment Status:	Closed

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patients scheduled for major thoracic surgery (lobectomy, pneumonectomy, esophagectomy).

2) Patients 18 years of age or older.

3) Patients who have signed the consent form to participate in the study.

4) Patients must have been evaluated in the Preanesthesia Clinic or by a staff Anesthesiologist preoperatively.

5) 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.

Exclusion Criteria:

1) Refusal to participate in the study.

2) Patient is under age 18.

3) Patient is unwilling to sign consent.

4) Patient is unable to exercise (bedridden or wheel chair bound).

5) Patient is enrolled in another study deemed by the investigator to affect oxygen metabolic efficiency and not presently the standard of care at MDACC.

6) Any patient whose condition is deemed unsatisfactory for surgery after the preanesthetic evaluation.

7) Surgery canceled for any reason. The patient may reenter the study if surgery is rescheduled.

8) Patient has had a myocardial infarction within 3 months of visiting the Preanesthesia Clinic or presents with new or unstable angina.

9) Patient has a history of cerebrovascular accident or transient ischemic attacks within 3 months of visiting the Preanesthesia Clinic.

10) Patient has a history of pulmonary embolic event within 3 months of visiting the Preanesthesia Clinic.

11) Patient known to have acute or chronic deep vein thrombosis.

12) Pregnant patients.

Links

Registration Number: NCT00384683
Study Information on Clinical Trials Registry (clinicaltrials.gov)