DyspneaNCT02105207
Comparison Between Lung Ultrasound and Chest Radiography for Acute Dyspnea
A study testing Lung Ultrasound and Chest Radiography in people with Dyspnea and Congestive Heart Failure, run by University of Turin, Italy at 2 sites in Italy.
Trial summary
For patients presenting to the Emergency Department with acute dyspnea, emergency physicians will be asked to categorize the diagnosis as acute decompensated heart failure or non-cardiogenic shortness of breath a) after the initial clinical assessment, and b) after performing lung ultrasound (LUS) for LUS arm or after… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea, Congestive Heart Failure
- What is being tested?
- Lung Ultrasound and Chest Radiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 530 participants
- Where
- 2 sitesItaly
- Study dates
- Jan 2014to Feb 2016
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute dyspnea as chief complaint
- presence of an emergency physician skilled in lung ultrasound at evaluation time
Who cannot join
- mechanical ventilation ongoing at enrolment time
- dyspnea clearly related to a different aetiology (e.g. trauma, anxiety, etc)
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Emergency Department Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, 50134
AOU Città della Salute e della Scienza di Torino
Turin, 10126
About this study
Official title: Comparison Between Lung Ultrasound and Chest Radiography for Differential Diagnosis of Acute Dyspnea in the Emergency Department
For patients presenting to the Emergency Department with acute dyspnea, emergency physicians will be asked to categorize the diagnosis as acute decompensated heart failure or non-cardiogenic shortness of breath a) after the initial clinical assessment, and b) after performing lung ultrasound (LUS) for LUS arm or after chest radiography (CXR) and natriuretic peptide (NT-pro BNP) results for CXR arm. All patients will undergo CXR, those enrolled in the LUS arm, after sonographic evaluation. After discharge, the cause of patient's dyspnea will be determined by independent review of the entire medical records performed by two emergency physicians. In case of disagreement, a third expert physician will review entire medical records, and adjudicate the case.
Read the detailed description
Study protocol After the initial standard work-up, which includes past medical history, history of the present illness, physical examination, ECG, and arterial blood gas analysis, the emergency physician responsible for patient care will be asked to categorize the diagnosis as ADHF or non-cardiogenic dyspnea.
Then, the patient will be assigned to one of the experimental arms. In the LUS arm, the same emergency physician will perform LUS, and express the new integrated presumptive etiology ("LUS-implemented" diagnosis). All patients will then undergo CXR.
In the CXR arm, patients will undergo CXR, and the new integrated etiology will be record after CXR and NT-proBNP results will be available.
After hospital discharge, two expert emergency physicians, blinded to LUS results, will independently review the entire medical record, and indicate the final diagnosis. In case of disagreement, a cardiologist will review the medical records, and adjudicate the case.
Statistical analysis The accuracy of each diagnostic tool will be expressed as sensitivity, specificity, predictive values and likelihood ratios obtained using 2 x 2 tables. "Positive" and "negative" results will be considered, for each test, the diagnosis of ADHF or non-cardiac dyspnea, respectively. Receiver operating characteristic (ROC) and area under curve (AUC) statistics will be also shown.
- Conditions
- Dyspnea, Congestive Heart Failure
- Being tested
- Lung Ultrasound, Chest Radiography
- Medical subject headings
- Dyspnea, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung UltrasoundOther
Lung ultrasound evaluation is performed after clinical assessment and before chest radiography
Chest RadiographyOther
Chest Radiography is performed after clinical evaluation without using ultrasound assessment
| Study group | Role | What they receive |
|---|---|---|
| Lung Ultrasound | Experimental | In Patients allocated to this arm Lung ultrasound for detection of interstitial syndrome will be performed before chest radiography. Receives: Other: Lung Ultrasound |
| Chest Radiography | Experimental | In Patients allocated to this arm chest radiography will be performed for the detection of indirect signs of pulmonary congestion/ADHF without ultrasound evaluation. Receives: Other: Chest Radiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Lung Ultrasound and Chest Radiography in dyspnoeic patients
Accuracy of lung ultrasound and chest radiography will be measured using as gold standard the independent evaluation of the entire medical records by two expert emergency physicians blinded to the lung ultrasound results and radiographic reports (digitalized chest radiography images will be available).
Measured: Accuracy will be measured at the end of clinical evaluation in the Emergency Department, an expected average of 2 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startJan 2014
- Primary completionMay 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for DyspneaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 530 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico Lupia, MD, PhD, University of Turin, Italy
- Investigators
- Enrico Lupia, MD, PhD, Principal investigator, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105207
- Sponsor's protocol ID
- iLUS-RCT
- Status last verified
- Apr 2016
- First submitted
- 27 Mar 2014
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Wang CS, FitzGerald JM, Schulzer M, Mak E, Ayas NT. Does this dyspneic patient in the emergency department have congestive heart failure? JAMA. 2005 Oct 19;294(15):1944-56. doi: 10.1001/jama.294.15.1944.
PubMed 16234501Niska R, Bhuiya F, Xu J. National Hospital Ambulatory Medical Care Survey: 2007 emergency department summary. Natl Health Stat Report. 2010 Aug 6;(26):1-31.
PubMed 20726217Peacock WF, Braunwald E, Abraham W, Albert N, Burnett J, Christenson R, Collins S, Diercks D, Fonarow G, Hollander J, Kellerman A, Gheorghiade M, Kirk D, Levy P, Maisel A, Massie BM, O'Connor C, Pang P, Shah M, Sopko G, Stevenson L, Storrow A, Teerlink J. National Heart, Lung, and Blood Institute working group on emergency department management of acute heart failure: research challenges and opportunities. J Am Coll Cardiol. 2010 Jul 27;56(5):343-51. doi: 10.1016/j.jacc.2010.03.051.
PubMed 20650354Ray P, Birolleau S, Lefort Y, Becquemin MH, Beigelman C, Isnard R, Teixeira A, Arthaud M, Riou B, Boddaert J. Acute respiratory failure in the elderly: etiology, emergency diagnosis and prognosis. Crit Care. 2006;10(3):R82. doi: 10.1186/cc4926. Epub 2006 May 24.
PubMed 16723034Redfield MM. Heart failure--an epidemic of uncertain proportions. N Engl J Med. 2002 Oct 31;347(18):1442-4. doi: 10.1056/NEJMe020115. No abstract available.
PubMed 12409548McCullough PA, Nowak RM, McCord J, Hollander JE, Herrmann HC, Steg PG, Duc P, Westheim A, Omland T, Knudsen CW, Storrow AB, Abraham WT, Lamba S, Wu AH, Perez A, Clopton P, Krishnaswamy P, Kazanegra R, Maisel AS. B-type natriuretic peptide and clinical judgment in emergency diagnosis of heart failure: analysis from Breathing Not Properly (BNP) Multinational Study. Circulation. 2002 Jul 23;106(4):416-22. doi: 10.1161/01.cir.0000025242.79963.4c.
PubMed 12135939McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Bohm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Kober L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Ronnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A; ESC Committee for Practice Guidelines. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2012 Jul;33(14):1787-847. doi: 10.1093/eurheartj/ehs104. Epub 2012 May 19. No abstract available.
PubMed 22611136Collins SP, Lindsell CJ, Storrow AB, Abraham WT; ADHERE Scientific Advisory Committee, Investigators and Study Group. Prevalence of negative chest radiography results in the emergency department patient with decompensated heart failure. Ann Emerg Med. 2006 Jan;47(1):13-8. doi: 10.1016/j.annemergmed.2005.04.003. Epub 2005 Jun 20.
PubMed 16387212Gillespie ND, McNeill G, Pringle T, Ogston S, Struthers AD, Pringle SD. Cross sectional study of contribution of clinical assessment and simple cardiac investigations to diagnosis of left ventricular systolic dysfunction in patients admitted with acute dyspnoea. BMJ. 1997 Mar 29;314(7085):936-40. doi: 10.1136/bmj.314.7085.936.
PubMed 9099117Lichtenstein DA, Meziere GA. Relevance of lung ultrasound in the diagnosis of acute respiratory failure: the BLUE protocol. Chest. 2008 Jul;134(1):117-25. doi: 10.1378/chest.07-2800. Epub 2008 Apr 10.
PubMed 18403664Volpicelli G, Mussa A, Garofalo G, Cardinale L, Casoli G, Perotto F, Fava C, Frascisco M. Bedside lung ultrasound in the assessment of alveolar-interstitial syndrome. Am J Emerg Med. 2006 Oct;24(6):689-96. doi: 10.1016/j.ajem.2006.02.013.
PubMed 16984837Liteplo AS, Marill KA, Villen T, Miller RM, Murray AF, Croft PE, Capp R, Noble VE. Emergency thoracic ultrasound in the differentiation of the etiology of shortness of breath (ETUDES): sonographic B-lines and N-terminal pro-brain-type natriuretic peptide in diagnosing congestive heart failure. Acad Emerg Med. 2009 Mar;16(3):201-10. doi: 10.1111/j.1553-2712.2008.00347.x. Epub 2009 Jan 29.
PubMed 19183402Picano E, Frassi F, Agricola E, Gligorova S, Gargani L, Mottola G. Ultrasound lung comets: a clinically useful sign of extravascular lung water. J Am Soc Echocardiogr. 2006 Mar;19(3):356-63. doi: 10.1016/j.echo.2005.05.019.
PubMed 16500505Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, Melniker L, Gargani L, Noble VE, Via G, Dean A, Tsung JW, Soldati G, Copetti R, Bouhemad B, Reissig A, Agricola E, Rouby JJ, Arbelot C, Liteplo A, Sargsyan A, Silva F, Hoppmann R, Breitkreutz R, Seibel A, Neri L, Storti E, Petrovic T; International Liaison Committee on Lung Ultrasound (ILC-LUS) for International Consensus Conference on Lung Ultrasound (ICC-LUS). International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012 Apr;38(4):577-91. doi: 10.1007/s00134-012-2513-4. Epub 2012 Mar 6.
PubMed 22392031Noble VE, Murray AF, Capp R, Sylvia-Reardon MH, Steele DJR, Liteplo A. Ultrasound assessment for extravascular lung water in patients undergoing hemodialysis. Time course for resolution. Chest. 2009 Jun;135(6):1433-1439. doi: 10.1378/chest.08-1811. Epub 2009 Feb 2.
PubMed 19188552
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Lung Ultrasound and Chest Radiography for Differential Diagnosis of Acute Dyspnea in the Emergency Department
- ClinicalTrials.gov ID
- NCT02105207
- Acronym / sponsor ID
- iLUS-RCT
- Conditions
- Dyspnea, Congestive Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 530 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 7 Apr 2014 (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.
For patients presenting to the Emergency Department with acute dyspnea, emergency physicians will be asked to categorize the diagnosis as acute decompensated heart failure or non-cardiogenic shortness of breath a) after the initial clinical assessment, and b) after performing lung ultrasound (LUS) for LUS arm or after chest radiography (CXR) and natriuretic peptide (NT-pro BNP) results for CXR arm. All patients will undergo CXR, those enrolled in the LUS arm, after sonographic evaluation. After discharge, the cause of patient's dyspnea will be determined by independent review of the entire medical records performed by two emergency physicians. In case of disagreement, a third expert physician will review entire medical records, and adjudicate the case.
Detailed description
Study protocol After the initial standard work-up, which includes past medical history, history of the present illness, physical examination, ECG, and arterial blood gas analysis, the emergency physician responsible for patient care will be asked to categorize the diagnosis as ADHF or non-cardiogenic dyspnea.
Then, the patient will be assigned to one of the experimental arms. In the LUS arm, the same emergency physician will perform LUS, and express the new integrated presumptive etiology ("LUS-implemented" diagnosis). All patients will then undergo CXR.
In the CXR arm, patients will undergo CXR, and the new integrated etiology will be record after CXR and NT-proBNP results will be available.
After hospital discharge, two expert emergency physicians, blinded to LUS results, will independently review the entire medical record, and indicate the final diagnosis. In case of disagreement, a cardiologist will review the medical records, and adjudicate the case.
Statistical analysis The accuracy of each diagnostic tool will be expressed as sensitivity, specificity, predictive values and likelihood ratios obtained using 2 x 2 tables. "Positive" and "negative" results will be considered, for each test, the diagnosis of ADHF or non-cardiac dyspnea, respectively. Receiver operating characteristic (ROC) and area under curve (AUC) statistics will be also shown.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung Ultrasound | Experimental | Other: Lung UltrasoundIn Patients allocated to this arm Lung ultrasound for detection of interstitial syndrome will be performed before chest radiography. |
| Chest Radiography | Experimental | Other: Chest RadiographyIn Patients allocated to this arm chest radiography will be performed for the detection of indirect signs of pulmonary congestion/ADHF without ultrasound evaluation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- acute dyspnea as chief complaint
- presence of an emergency physician skilled in lung ultrasound at evaluation time
Key exclusion criteria (2 listed)
- mechanical ventilation ongoing at enrolment time
- dyspnea clearly related to a different aetiology (e.g. trauma, anxiety, etc)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung UltrasoundLung ultrasound evaluation is performed after clinical assessment and before chest radiography | Other | Lung Ultrasound |
| Chest RadiographyChest Radiography is performed after clinical evaluation without using ultrasound assessment | Other | Chest Radiography |
Primary outcome
Accuracy of Lung Ultrasound and Chest Radiography in dyspnoeic patients
Time frame: Accuracy will be measured at the end of clinical evaluation in the Emergency Department, an expected average of 2 hours.
Accuracy of lung ultrasound and chest radiography will be measured using as gold standard the independent evaluation of the entire medical records by two expert emergency physicians blinded to the lung ultrasound results and radiographic reports (digitalized chest radiography images will be available).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
- Background: PubMed 16234501Wang CS, FitzGerald JM, Schulzer M, Mak E, Ayas NT. Does this dyspneic patient in the emergency department have congestive heart failure? JAMA. 2005 Oct 19;294(15):1944-56. doi: 10.1001/jama.294.15.1944.
- Background: PubMed 20726217Niska R, Bhuiya F, Xu J. National Hospital Ambulatory Medical Care Survey: 2007 emergency department summary. Natl Health Stat Report. 2010 Aug 6;(26):1-31.
- Background: PubMed 20650354Peacock WF, Braunwald E, Abraham W, Albert N, Burnett J, Christenson R, Collins S, Diercks D, Fonarow G, Hollander J, Kellerman A, Gheorghiade M, Kirk D, Levy P, Maisel A, Massie BM, O'Connor C, Pang P, Shah M, Sopko G, Stevenson L, Storrow A, Teerlink J. National Heart, Lung, and Blood Institute working group on emergency department management of acute heart failure: research challenges and opportunities. J Am Coll Cardiol. 2010 Jul 27;56(5):343-51. doi: 10.1016/j.jacc.2010.03.051.
- Background: PubMed 16723034Ray P, Birolleau S, Lefort Y, Becquemin MH, Beigelman C, Isnard R, Teixeira A, Arthaud M, Riou B, Boddaert J. Acute respiratory failure in the elderly: etiology, emergency diagnosis and prognosis. Crit Care. 2006;10(3):R82. doi: 10.1186/cc4926. Epub 2006 May 24.
- Background: PubMed 12409548Redfield MM. Heart failure--an epidemic of uncertain proportions. N Engl J Med. 2002 Oct 31;347(18):1442-4. doi: 10.1056/NEJMe020115. No abstract available.
- Background: PubMed 12135939McCullough PA, Nowak RM, McCord J, Hollander JE, Herrmann HC, Steg PG, Duc P, Westheim A, Omland T, Knudsen CW, Storrow AB, Abraham WT, Lamba S, Wu AH, Perez A, Clopton P, Krishnaswamy P, Kazanegra R, Maisel AS. B-type natriuretic peptide and clinical judgment in emergency diagnosis of heart failure: analysis from Breathing Not Properly (BNP) Multinational Study. Circulation. 2002 Jul 23;106(4):416-22. doi: 10.1161/01.cir.0000025242.79963.4c.
- Background: PubMed 22611136McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Bohm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Kober L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Ronnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A; ESC Committee for Practice Guidelines. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2012 Jul;33(14):1787-847. doi: 10.1093/eurheartj/ehs104. Epub 2012 May 19. No abstract available.
- Background: PubMed 16387212Collins SP, Lindsell CJ, Storrow AB, Abraham WT; ADHERE Scientific Advisory Committee, Investigators and Study Group. Prevalence of negative chest radiography results in the emergency department patient with decompensated heart failure. Ann Emerg Med. 2006 Jan;47(1):13-8. doi: 10.1016/j.annemergmed.2005.04.003. Epub 2005 Jun 20.
- Background: PubMed 9099117Gillespie ND, McNeill G, Pringle T, Ogston S, Struthers AD, Pringle SD. Cross sectional study of contribution of clinical assessment and simple cardiac investigations to diagnosis of left ventricular systolic dysfunction in patients admitted with acute dyspnoea. BMJ. 1997 Mar 29;314(7085):936-40. doi: 10.1136/bmj.314.7085.936.
- Background: PubMed 18403664Lichtenstein DA, Meziere GA. Relevance of lung ultrasound in the diagnosis of acute respiratory failure: the BLUE protocol. Chest. 2008 Jul;134(1):117-25. doi: 10.1378/chest.07-2800. Epub 2008 Apr 10.
- Background: PubMed 16984837Volpicelli G, Mussa A, Garofalo G, Cardinale L, Casoli G, Perotto F, Fava C, Frascisco M. Bedside lung ultrasound in the assessment of alveolar-interstitial syndrome. Am J Emerg Med. 2006 Oct;24(6):689-96. doi: 10.1016/j.ajem.2006.02.013.
- Background: PubMed 19183402Liteplo AS, Marill KA, Villen T, Miller RM, Murray AF, Croft PE, Capp R, Noble VE. Emergency thoracic ultrasound in the differentiation of the etiology of shortness of breath (ETUDES): sonographic B-lines and N-terminal pro-brain-type natriuretic peptide in diagnosing congestive heart failure. Acad Emerg Med. 2009 Mar;16(3):201-10. doi: 10.1111/j.1553-2712.2008.00347.x. Epub 2009 Jan 29.
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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.
Enrico Lupia, MD, PhD principal investigator
University of Turin, Italy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung Ultrasound and Chest Radiography in people with Dyspnea and Congestive Heart Failure, run by University of Turin, Italy at 2 sites in Italy.
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 2 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: finished, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Accuracy of Lung Ultrasound and Chest Radiography in dyspnoeic patients (time frame: Accuracy will be measured at the end of clinical evaluation in the Emergency Department, an expected average of 2 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02105207, which also lists 28 linked publications.
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 6 Apr 2016.