Coronary Artery DiseaseNCT01809730
Pilot Study: Cardiovascular Events in High Risk Orthopedic Surgical Patients
An observational study of Coronary Artery Disease and Cerebral Vascular Disease, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Coronary Artery Disease, Cerebral Vascular Disease, Peripheral Artery Disease
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- • ≥ 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
Show all 15Show fewer
- 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
Who cannot join
- • Severe co-morbid condition with life expectancy < 6 months
- Inability to give informed consent or adhere to follow-up as per protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Hospital for Joint Diseases
New York, New York, 10003
About this study
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.
Read the detailed 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.
- Conditions
- Coronary Artery Disease, Cerebral Vascular Disease, Peripheral Artery Disease, Renal Insufficiency, Diabetes, COPD
- Medical subject headings
- Coronary Artery Disease, Peripheral Arterial Disease, Renal Insufficiency, Diabetes Mellitus, Pulmonary Disease, Chronic Obstructive, Hypertension, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cardiovascular risk | patients with CV disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac ischemia/necrosis
Measured: 30 days
Venous thromboembolism
Measured: 30 days
Pulmonary embolism
Measured: 30 dyas
Myocardial infarction
Measured: 30 Days
Cerebral vascular event
Measured: 30 days
Death
Measured: 30 days
Transient ischemic attack
Measured: 30 days
Surgical site infection
Measured: 30 days
Delayed wound healing
Measured: 30 days
Clinically relevant bleeding
Measured: 30 days
Transfusion within 48 hours post-op
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startMay 2012
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Why it stopped: no participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01809730
- Sponsor's protocol ID
- S12-02513
- Status last verified
- Nov 2015
- First submitted
- 11 Mar 2013
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Cardiovascular Events in High Risk Orthopedic Surgical Patients
- ClinicalTrials.gov ID
- NCT01809730
- Acronym / sponsor ID
- S12-02513
- Conditions
- Coronary Artery Disease, Cerebral Vascular Disease, Peripheral Artery Disease, Renal Insufficiency, Diabetes, COPD
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 13 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiovascular risk | – | –patients with CV disease |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (15 listed)
- • ≥ 21 years of age
Key exclusion criteria (2 listed)
- • Severe co-morbid condition with life expectancy < 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiac ischemia/necrosis
Time frame: 30 days
Venous thromboembolism
Time frame: 30 days
Pulmonary embolism
Time frame: 30 dyas
Myocardial infarction
Time frame: 30 Days
Cerebral vascular event
Time frame: 30 days
Death
Time frame: 30 days
Transient ischemic attack
Time frame: 30 days
Surgical site infection
Time frame: 30 days
Delayed wound healing
Time frame: 30 days
Clinically relevant bleeding
Time frame: 30 days
Transfusion within 48 hours post-op
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Cerebral Vascular Disease, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac ischemia/necrosis (time frame: 30 days). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2015.