Pilot Study: Cardiovascular Events in High Risk Orthopedic Surgical Patients

Hypertension Clinical Trial

Official title:

Pilot Study: Cardiovascular Events in High Risk Orthopedic Surgical Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01809730
• Other study ID #: S12-02513
• Status: Withdrawn
• Phase: N/A
• First received: March 11, 2013
• Last updated: November 16, 2015
• Start date: May 2012
• Est. completion date: January 2020

Study information

• Verified date: November 2015
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This is a non-randomized, non-interventional pilot observational study designed to follow high-risk patients through their surgical and hospital stay. The investigators will collect 2 4ml vial's of blood (total of 8ml) prior to surgery to assess CV biomarkers - inflammatory, metabolic, hypercoagulable and platelet.

Description:

This study is primarily an observational pilot study. After identifying patients as high-risk according to the following criteria: CAD and/or CVD and/or PAD and/or >=60 years old and at least 2 of the following - renal insufficiency, diabetes, COPD, hypertension, active smoker (or active within 6 months of consent), cancer, congestive heart failure, or any blood clot - they will be asked to sign a consent form. Patients surgical and hospital course will continue as per standard of care. Prior to surgery, 8ml of blood will be collected for to assess cardiovascular biomarkers including inflammatory, metabolic, hypercoagulable and platelet biomarkers to be tested independently in Dr. Berger's lab in Smilow. Study staff will perform electrocardiograms on POD 2. Results of these ECGs will not be placed in the patients' charts. No other procedures will be done for research purposes only.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• • = 21 years of age

• Subjects undergoing open orthopedic surgery of the hip, knee or spine

• High-risk subject cohort:

• Coronary artery disease (CAD), or

• Cerebrovascular disease (CVD) (prior stroke, TIA or carotid artery disease (>70% stenosis), or

• Peripheral artery disease (PAD), or

• Age = 60 years and any 2 of the following:

• Renal insufficiency (creatinine clearance < 60ml/min)

• Diabetes

• Chronic Obstructive Pulmonary Disease (COPD)

• Hypertension

• Active smoker or stopped less than 30 days prior to consent

• Cancer

• Congestive heart failure

• Prior blood clot

Exclusion Criteria:

• • Severe co-morbid condition with life expectancy < 6 months

• Inability to give informed consent or adhere to follow-up as per protocol

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Active Smoker
• Cancer
• Cerebral Vascular Disease
• CHF
• COPD
• Coronary Artery Disease
• Coronary Disease
• Diabetes
• Hypertension
• Myocardial Ischemia
• Peripheral Arterial Disease
• Peripheral Artery Disease
• Prior DVT/PE
• Renal Insufficiency
• Vascular Diseases

Locations

Country	Name	City	State
United States	NYU Hospital for Joint Diseases	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac ischemia/necrosis		30 days	No
Primary	Venous thromboembolism		30 days	No
Primary	Pulmonary embolism		30 dyas	No
Primary	Myocardial infarction		30 Days	No
Primary	Cerebral vascular event		30 days	No
Primary	Death		30 days	No
Primary	Transient ischemic attack		30 days	No
Primary	Surgical site infection		30 days	No
Primary	Delayed wound healing		30 days	No
Primary	Clinically relevant bleeding		30 days	No
Primary	Transfusion within 48 hours post-op		30 days	No