Clinical trial · Observational
Pilot Study: Cardiovascular Events in High Risk Orthopedic Surgical Patients
NCT01809730CI-TRIAL-00019820withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): no participants enrolled
Summary
Brief summary (as posted)
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
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Active Smoker | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Cerebral Vascular Disease | — | UNRESOLVED | — |
| CHF | — | UNRESOLVED | — |
| COPD | — | UNRESOLVED | — |
| Coronary Artery Disease | — | UNRESOLVED | — |
| Diabetes | — | UNRESOLVED | — |
| Hypertension | — | UNRESOLVED | — |
| Peripheral Artery Disease | — | UNRESOLVED | — |
| Prior DVT/PE | — | UNRESOLVED | — |
| Renal Insufficiency | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Cardiovascular risk
- description
- patients with CV disease
Primary outcomes (11)
- measure
- Cardiac ischemia/necrosis
- timeFrame
- 30 days
- measure
- Venous thromboembolism
- timeFrame
- 30 days
- measure
- Pulmonary embolism
- timeFrame
- 30 dyas
- measure
- Myocardial infarction
- timeFrame
- 30 Days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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 protocolReferences
Publications (0)
Data not yet available
No reference posted for this study.