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| Name | Class |
|---|---|
| MOUNT SINAI HOSPITAL | OTHER |
| University at Buffalo | OTHER |
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Objective: The primary objective of this multicenter prospective registry is to provide additional safety, technical outcomes and clinical outcomes data for minimally invasive endoscopic surgery (MIES) with Apollo or Artemis for the evacuation of supratentorial brain hemorrhage in adult patients who do not qualify for the concurrent INVEST Feasibility randomized controlled trial at active INVEST centers.
Study Design: This study will be a prospective, non-randomized, multi-center, single arm registry that will enroll up to 50 patients, however may increase to 200 at up to 10 US centers.
Patient Population: Adult patients with supratentorial brain hemorrhages (ICH and/or IVH) who do not meet all INCLUSION criteria or who meet one or more EXCLUSION criteria for the INVEST trial, but who will ultimately undergo MIES with Apollo or Artemis at active INVEST centers.
Indication: The Artemis Neuro Evacuation Device is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum in conjunction with a Penumbra Aspiration Pump. The Penumbra Aspiration Pump is indicated as a vacuum source for the Penumbra Aspiration Systems. The Apollo system has been cleared for the controlled aspiration of soft tissue and/or fluid during endoscopically guided neurosurgery of the ventricular system. In the present study, the researchers propose to investigate the safety and efficacy of this system for the minimally invasive evacuation of brain hemorrhage - both IVH, IVH with ICH and ICH alone - in patients who do not qualify for the INVEST trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Brain Hemorrhage | Experimental | Subjects will receive best medical management for ICH plus they will receive the MIES surgery and use of the Apollo or Artemis System for clot evacuation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apollo Device | Device | The Apollo system has been cleared for the controlled aspiration of soft tissue and/or fluid during endoscopically guided neurosurgery of the ventricular system. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Modified Rankin Score (mRS) ≤ 3 or mRS > 3 | Clinical Efficacy Endpoint: global disability assessed via the modified Rankin score (mRS). 180-day global disability assessed via the modified Rankin score (mRS), categorized as either mRS ≤ 3 or mRS > 3 | 180 days |
| Number of Participants With Surgical Success Rate | Technical Efficacy Endpoint measured by rate of surgical success. Surgical Success Rate is defined as reduction to < 15 cc total volume AND >60% reduction in hemorrhage volume on immediate post-treatment CT scan | immediately post-procedure |
| Number of Participants With Surgical Success Rate Regarding IVH | Technical Efficacy Endpoint measured by rate of surgical success. Surgical Success Rate is defined as Intraventricular hemorrhage (IVH): mGraeb score of < 5 on day 7 CT scan | 7 days post-procedure |
| Rate of Mortality | 30 days post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Rankin Score (mRS) at 30 Days | 0: No symptoms at all
|
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Inclusion Criteria:
Patient age 022 years or older
Supratentorial brain hemorrhage, which may be:
Patient does not qualify for the concurrent INVEST Feasibility study
Exclusion Criteria:
Imaging
Coagulation Issues
Patient Factors
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| Name | Affiliation | Role |
|---|---|---|
| J Mocco, MD, MS | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Washington University | Washington D.C. | District of Columbia | 20037 | United States | ||
| University of Louisville |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Brain Hemorrhage | Subjects will receive best medical management for ICH plus they will receive the MIES surgery and use of the Apollo or Artemis System for clot evacuation. Apollo Device: The Apollo system has been cleared for the controlled aspiration of soft tissue and/or fluid during endoscopically guided neurosurgery of the ventricular system. Artemis Device: The Artemis Neuro Evacuation Device is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum in conjunction with a Penumbra Aspiration Pump. The Penumbra Aspiration Pump is indicated as a vacuum source for the Penumbra Aspiration Systems. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 24, 2017 |
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| Artemis Device | Device | The Artemis Neuro Evacuation Device is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum in conjunction with a Penumbra Aspiration Pump. The Penumbra Aspiration Pump is indicated as a vacuum source for the Penumbra Aspiration Systems. |
|
| 30 days post-procedure |
| Modified Rankin Score (mRS) at 90 Days | 0: No symptoms at all
| 90 days post-procedure |
| Length of Hospital Stay | average of 17 days |
| Number of Participants Requiring VPS | Number of participants requiring Ventriculoperitoneal Shunt (VPS) | average of 17 days |
| Louisville |
| Kentucky |
| 40202 |
| United States |
| University of Buffalo | Buffalo | New York | 14260 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Prisma Health | Greenville | South Carolina | 29601 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Brain Hemorrhage | Subjects will receive best medical management for ICH plus they will receive the MIES surgery and use of the Apollo or Artemis System for clot evacuation. Apollo Device: The Apollo system has been cleared for the controlled aspiration of soft tissue and/or fluid during endoscopically guided neurosurgery of the ventricular system. Artemis Device: The Artemis Neuro Evacuation Device is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum in conjunction with a Penumbra Aspiration Pump. The Penumbra Aspiration Pump is indicated as a vacuum source for the Penumbra Aspiration Systems. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Tobacco use | Count of Participants | Participants |
| |||||||||||||||||||||||
| Cocaine or methamphetamine use | Count of Participants | Participants |
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| On anticoagulant therapy | Count of Participants | Participants |
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| On antiplatelet therapy | Count of Participants | Participants |
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| On NSAID therapy | Count of Participants | Participants |
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| On antihypertensive therapy | Count of Participants | Participants |
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| Medical comorbidities | Count of Participants | Participants |
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| Location of intracerebral hemorrhage | Count of Participants | Participants |
| |||||||||||||||||||||||
| mRS before stroke | modified Rankin Scale (mRS): 0 - No symptoms.
| Count of Participants | Participants |
| ||||||||||||||||||||||
| Intracerebral hemorrhage (ICH) volume | Median | Inter-Quartile Range | milliliters |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Modified Rankin Score (mRS) ≤ 3 or mRS > 3 | Clinical Efficacy Endpoint: global disability assessed via the modified Rankin score (mRS). 180-day global disability assessed via the modified Rankin score (mRS), categorized as either mRS ≤ 3 or mRS > 3 | one participant lost to follow-up after 1 month. | Posted | Count of Participants | Participants | 180 days |
|
|
| |||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Surgical Success Rate | Technical Efficacy Endpoint measured by rate of surgical success. Surgical Success Rate is defined as reduction to < 15 cc total volume AND >60% reduction in hemorrhage volume on immediate post-treatment CT scan | Posted | Count of Participants | Participants | immediately post-procedure |
|
| |||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Surgical Success Rate Regarding IVH | Technical Efficacy Endpoint measured by rate of surgical success. Surgical Success Rate is defined as Intraventricular hemorrhage (IVH): mGraeb score of < 5 on day 7 CT scan | Posted | Count of Participants | Participants | 7 days post-procedure |
|
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| Primary | Rate of Mortality | Posted | Count of Participants | Participants | 30 days post procedure |
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| Secondary | Modified Rankin Score (mRS) at 30 Days | 0: No symptoms at all
| Posted | Count of Participants | Participants | 30 days post-procedure |
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| Secondary | Modified Rankin Score (mRS) at 90 Days | 0: No symptoms at all
| Posted | Count of Participants | Participants | 90 days post-procedure |
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| Secondary | Length of Hospital Stay | Posted | Median | Inter-Quartile Range | days | average of 17 days |
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| Secondary | Number of Participants Requiring VPS | Number of participants requiring Ventriculoperitoneal Shunt (VPS) | Posted | Count of Participants | Participants | average of 17 days |
|
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up to 6 months post-procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With Brain Hemorrhage | Subjects will receive best medical management for ICH plus they will receive the MIES surgery and use of the Apollo or Artemis System for clot evacuation. Apollo Device: The Apollo system has been cleared for the controlled aspiration of soft tissue and/or fluid during endoscopically guided neurosurgery of the ventricular system. Artemis Device: The Artemis Neuro Evacuation Device is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum in conjunction with a Penumbra Aspiration Pump. The Penumbra Aspiration Pump is indicated as a vacuum source for the Penumbra Aspiration Systems. | 4 | 38 | 20 | 38 | 25 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Acute hemorrhage | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Acute inflammatory demyelinating polyneuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Aspiration pneumonia/fever | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| C. diff infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Cranioplasty infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Deep venous thrombosis | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
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| Facial fractures | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
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| Deep seated right brain lesion due to brain abscess | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Pancreatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
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| Pneumonia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Polycythemia vera | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pulmonary embolism | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| R frontal ICH | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sepsis secondary to aspiration | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Stroke | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Syncope | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Wound infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Wound infection and cerebral abscess | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | CTCAE (unspecified) | Non-systematic Assessment |
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| Acute encephalopathy | Nervous system disorders | CTCAE (unspecified) | Non-systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | CTCAE (unspecified) | Non-systematic Assessment |
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| Aspiration pneumonia | Infections and infestations | CTCAE (unspecified) | Non-systematic Assessment |
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| Back rash | Immune system disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Chest pain - cardiac | Cardiac disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Craniotomy site oozing | Injury, poisoning and procedural complications | CTCAE (unspecified) | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Fever | General disorders | CTCAE (unspecified) | Non-systematic Assessment |
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| Hematoma | Vascular disorders | CTCAE (unspecified) | Non-systematic Assessment |
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| Hydrocephalus | Nervous system disorders | CTCAE (unspecified) | Non-systematic Assessment |
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| Hyperchloremia | Investigations | CTCAE (unspecified) | Non-systematic Assessment |
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| Hypernatremia | Investigations | CTCAE (unspecified) | Non-systematic Assessment |
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| Hypertension/hypertensive episode | Vascular disorders | CTCAE (unspecified) | Non-systematic Assessment |
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| Hypomagnesemia | Investigations | CTCAE (unspecified) | Non-systematic Assessment |
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| Hypopotassemia | Investigations | CTCAE (unspecified) | Non-systematic Assessment |
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| Intraventricular hemorrhage | Nervous system disorders | CTCAE (unspecified) | Non-systematic Assessment |
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| L great toe abscess | Infections and infestations | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | CTCAE (unspecified) | Non-systematic Assessment |
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| Pulmonary edema | Reproductive system and breast disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Pulmonary emboli | Vascular disorders | CTCAE (unspecified) | Non-systematic Assessment |
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| Seizure | Nervous system disorders | CTCAE (unspecified) | Non-systematic Assessment |
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| Stroke | Nervous system disorders | CTCAE (unspecified) | Non-systematic Assessment |
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| Suicide attempt | Psychiatric disorders | CTCAE (unspecified) | Non-systematic Assessment |
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| Transaminitis | Investigations | CTCAE (unspecified) | Non-systematic Assessment |
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| Urinary retention | Renal and urinary disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Worsening of chronic kidney disease | Renal and urinary disorders | CTCAE (unspecified) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sydney Edwards | Icahn School of Medicine at Mount Sinai | 212-241-2524 | sydney.edwards@mountsinai.org |
| May 15, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 29, 2020 | May 16, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Currently smoking (or quit within the last 6 months) |
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| Other cardiovascular disease |
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| 2 |
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| 3 |
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