Pilot Study: Cardiovascular Events in High Risk Orthopedic Surgical Patients

NCT01809730 | Withdrawn

• 1 other identifier: S12-02513
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease; Cerebral Vascular Disease; Peripheral Artery Disease; Renal Insufficiency; Diabetes; COPD; Hypertension; Active Smoker; Cancer; CHF; Prior DVT/PE

Outcome Measures

Primary Outcomes (11)

• Cardiac ischemia/necrosis

  30 days

• Venous thromboembolism

  30 days

• Pulmonary embolism

  30 dyas

• Myocardial infarction

  30 Days

• Cerebral vascular event

  30 days

• Death

  30 days

• Transient ischemic attack

  30 days

• Surgical site infection

  30 days

• Delayed wound healing

  30 days

• Clinically relevant bleeding

  30 days

• Transfusion within 48 hours post-op

  30 days

Study Arms (1)

Cardiovascular risk

patients with CV disease

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This pilot, observational study is designed to identify and follow orthopedic surgical patients meeting specific high-risk criteria for postoperative cardiovascular events. All normal standard of care will be maintained. Patients will be observed from Pre-Admission Testing (PAT) visit through hospital discharge.

You may qualify if:

• ≥ 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

You may not qualify if:

• Severe co-morbid condition with life expectancy \< 6 months
• Inability to give informed consent or adhere to follow-up as per protocol

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Hospital for Joint Diseases

New York, New York, 10003, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

CV biomarkers - inflammatory, metabolic, hypercoagulable and platelet.

MeSH Terms

Conditions

Coronary Artery Disease; Peripheral Arterial Disease; Renal Insufficiency; Diabetes Mellitus; Pulmonary Disease, Chronic Obstructive; Hypertension; Neoplasms

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Atherosclerosis; Peripheral Vascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: March 11, 2013
• First Posted: March 13, 2013
• Study Start: May 1, 2012
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: November 17, 2015

Record last verified: 2015-11

Locations

US (1)