Shock, CardiogenicSMART-RESCUENCT02985008
Clinical Outcomes and Efficacy of Left Ventricular Assist Device for Korean Patients With Cardiogenic Shock
An observational study of Shock, Cardiogenic, run by Jeong Hoon Yang at 1 site in South Korea.
Trial summary
Retrospectively and prospectively enrolled patients with cardiogenic shock in domestic manifolds and investigated the current state of treatment and clinical features of cardiogenic shock in Koreans and identified the factors that could improve the prognosis and the use of IABP and ECMO And to investigate its… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Shock, Cardiogenic
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2016to Dec 2019
- How long will I take part?
- 1 Year
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Total: 1,000 * Cardiogenic shock group with inserted IABP, ECMO : 400 * Cardiogenic shock group without inserted IABP, ECMO : 600
Who may be able to join
- 19 years old or older
- ① Systolic blood pressure is less than 90mmHg for more than 30 minutes despite the fluid therapy, or Use of pressure boosting agents is necessary.
- ② Peripheral hypopnea (cold skin, urine less than 30 cc per hour, impaired consciousness, lactate ≥2.0 mmol / l) or a person with pulmonary edema.
- Causes of cardiogenic shock include acute myocardial infarction (including in coronary intervention), cardiomyopathy, myocarditis, pulmonary embolism, refractory ventricular tachycardia, shock during coronary intervention.
- Those voluntarily consenting to the medical records and the data necessary for the study during the entire study period.
Who cannot join
- Other causes except for cardiogenic shock (low blood pressure, septic, obstructive shock)
- Shock with cardiac arrest outside the hospital
- People with allergic reactions to anticoagulants such as heparin.
- Those who refused active treatment.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, Seoul, KS013
Jeong Hoon Yang, jeonghoon.yang@samsung.com
About this study
Official title: SMart Angioplasty Research Team: A Multi-center, Open, REtrospective and Prospective Observational Study to Investigate Clinical oUtcomes and Efficacy of Left Ventricular Assist Device for Korean Patients With Cardiogenic Shock : RESCUE
Retrospectively and prospectively enrolled patients with cardiogenic shock in domestic manifolds and investigated the current state of treatment and clinical features of cardiogenic shock in Koreans and identified the factors that could improve the prognosis and the use of IABP and ECMO And to investigate its therapeutic effect.
Read the detailed description
- The selection / exclusion criteria for persons with cardiogenic shock should be verified by medical records from January 1, 2014 before the approval date of each institution's clinical trial screening committee.
- If a cardiogenic shock to the selection criteria is found in the emergency room, general ward, or intensive care unit of the participating institutions, enroll in this study and fill in the information according to the e-CRF.
- After 1, 6 and 12 months, visit the hospital for examination and procedures. The person in charge of the examination or the delegate of the examiner may follow the person by telephone or an outpatient visit.
- Conditions
- Shock, Cardiogenic
- Keywords
- Shock, IVBP, ECMO, In hospital death
- Medical subject headings
- Shock, Cardiogenic, Shock
What is being measured
The primary outcome is the main question the study is designed to answer.
In hospital death
Measured: for 1 year
Secondary outcomes (7)
Death in 28days
Measured: 28days
Death in 1 year
Measured: 1 year
Death, myocardial infarction, stroke, re-admission due to heart failure during follow-up.
Measured: 1 year
Number of days of intensive care unit Number of days of intensive care unit
Measured: 1 year
hospitalization days
Measured: 1 year
Lactate 24 hour clearance
Measured: 1 year
Successful removal of left ventricular assist device (IABP, ECMO)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Shock, CardiogenicStudies 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
- Observational
- Observational model
- Cohort
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Jeong Hoon Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jeong Hoon Yang, Samsung Medical Center
- Investigators
- Jeong Hoon Yang, Study chair, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985008
- Sponsor's protocol ID
- 2016-03-130
- Acronym
- SMART-RESCUE
- Status last verified
- Dec 2016
- First submitted
- 5 Dec 2016
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Thiele H, Allam B, Chatellier G, Schuler G, Lafont A. Shock in acute myocardial infarction: the Cape Horn for trials? Eur Heart J. 2010 Aug;31(15):1828-35. doi: 10.1093/eurheartj/ehq220. Epub 2010 Jul 7.
PubMed 20610640Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J, de Waha A, Richardt G, Hennersdorf M, Empen K, Fuernau G, Desch S, Eitel I, Hambrecht R, Lauer B, Bohm M, Ebelt H, Schneider S, Werdan K, Schuler G; Intraaortic Balloon Pump in cardiogenic shock II (IABP-SHOCK II) trial investigators. Intra-aortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock (IABP-SHOCK II): final 12 month results of a randomised, open-label trial. Lancet. 2013 Nov 16;382(9905):1638-45. doi: 10.1016/S0140-6736(13)61783-3. Epub 2013 Sep 3.
PubMed 24011548Rousse N, Juthier F, Pincon C, Hysi I, Banfi C, Robin E, Fayad G, Jegou B, Prat A, Vincentelli A. ECMO as a bridge to decision: Recovery, VAD, or heart transplantation? Int J Cardiol. 2015;187:620-7. doi: 10.1016/j.ijcard.2015.03.283. Epub 2015 Mar 20.
PubMed 25863737Napp LC, Brehm M, Kuhn C, Schafer A, Bauersachs J. Heart against veno-arterial ECMO: Competition visualized. Int J Cardiol. 2015;187:164-5. doi: 10.1016/j.ijcard.2015.03.311. Epub 2015 Mar 21. No abstract available.
PubMed 25828345Park IH, Kim CH, Jang WJ, Oh JH, Lee WS, Yang JH, Gwon HC. Sex-Specific Differences in Management and Outcomes of Cardiogenic Shock Patients With and Without Ischemic Cardiomyopathy. Korean Circ J. 2025 Sep;55(9):795-809. doi: 10.4070/kcj.2024.0440. Epub 2025 May 28.
PubMed 40537419Kim O, Hong D, Choi KH, Lee JM, Park TK, Song YB, Hahn JY, Choi SH, Cho YH, Gwon HC, Yang JH. Sex Differences in Patients With Cardiogenic Shock Receiving Venoarterial Extracorporeal Membrane Oxygenation. Korean Circ J. 2025 Jun;55(6):541-551. doi: 10.4070/kcj.2024.0330. Epub 2025 Feb 10.
PubMed 40097285Cha JH, Choi KH, Ahn CM, Yu CW, Park IH, Jang WJ, Kim HJ, Bae JW, Kwon SU, Lee HJ, Lee WS, Jeong JO, Park SD, Park TK, Lee JM, Song YB, Hahn JY, Choi SH, Gwon HC, Yang JH. Machine learning prediction of in-hospital mortality and external validation in patients with cardiogenic shock: the RESCUE score. Rev Esp Cardiol (Engl Ed). 2025 Aug;78(8):707-716. doi: 10.1016/j.rec.2025.01.003. Epub 2025 Jan 22. English, Spanish.
PubMed 39855461Jung S, Jang WJ, Lee WS, Park IH, Oh JH, Yang JH, Gwon HC, Ahn CM, Yu CW, Kim HJ, Bae JW, Kwon SU, Lee HJ, Jeong JO, Park SD. Seasonal variation and prognosis in patients with acute myocardial infarction complicated by cardiogenic shock. Heliyon. 2024 Apr 24;10(9):e30078. doi: 10.1016/j.heliyon.2024.e30078. eCollection 2024 May 15.
PubMed 38720697Hong D, Choi KH, Ahn CM, Yu CW, Park IH, Jang WJ, Kim HJ, Bae JW, Kwon SU, Lee HJ, Lee WS, Jeong JO, Park SD, Park TK, Lee JM, Song YB, Hahn JY, Choi SH, Gwon HC, Yang JH. Clinical significance of residual ischaemia in acute myocardial infarction complicated by cardiogenic shock undergoing venoarterial-extracorporeal membrane oxygenation. Eur Heart J Acute Cardiovasc Care. 2024 Jul 24;13(7):525-534. doi: 10.1093/ehjacc/zuae058.
PubMed 38701179Jang WJ, Park IH, Oh JH, Choi KH, Song YB, Hahn JY, Choi SH, Gwon HC, Ahn CM, Yu CW, Kim HJ, Bae JW, Kwon SU, Lee HJ, Lee WS, Jeong JO, Park SD, Yang JH. Efficacy and safety of durable versus biodegradable polymer drug-eluting stents in patients with acute myocardial infarction complicated by cardiogenic shock. Sci Rep. 2024 Mar 15;14(1):6301. doi: 10.1038/s41598-024-56925-2.
PubMed 38491111Jeong JH, Kook H, Lee SH, Joo HJ, Park JH, Hong SJ, Kim MN, Park SM, Jung JS, Yang JH, Gwon HC, Ahn CM, Jang WJ, Kim HJ, Bae JW, Kwon SU, Lee WS, Jeong JO, Park SD, Lim SH, Lee J, Lee J, Yu CW. Prediction of In-Hospital Mortality for Ischemic Cardiogenic Shock Requiring Venoarterial Extracorporeal Membrane Oxygenation. J Am Heart Assoc. 2024 Feb 20;13(4):e032701. doi: 10.1161/JAHA.123.032701. Epub 2024 Feb 16.
PubMed 38362865Kim Y, Jang WJ, Park IH, Oh JH, Yang JH, Gwon HC, Ahn CM, Yu CW, Kim HJ, Bae JW, Kwon SU, Lee HJ, Lee WS, Jeong JO, Park SD. Prognostic effect of sex according to shock severity in patients with acute myocardial infarction complicated by cardiogenic shock. Hellenic J Cardiol. 2025 Mar-Apr;82:3-14. doi: 10.1016/j.hjc.2023.11.007. Epub 2023 Dec 10.
PubMed 38072307Lee HH, Jang WJ, Ahn CM, Chun WJ, Oh JH, Park YH, Lee SJ, Hong SJ, Yang JH, Kim JS, Kim HC, Kim BK, Yu CW, Kim HJ, Bae JW, Ko YG, Choi D, Gwon HC, Hong MK, Jang Y. Association of Prophylactic Distal Perfusion Cannulation With Mortality in Patients Receiving Venoarterial Extracorporeal Membrane Oxygenation. Am J Cardiol. 2023 Nov 15;207:418-425. doi: 10.1016/j.amjcard.2023.07.149. Epub 2023 Oct 3.
PubMed 37797547Choi KH, Yang JH, Park TK, Lee JM, Song YB, Hahn JY, Choi SH, Ahn CM, Yu CW, Park IH, Jang WJ, Kim HJ, Bae JW, Kwon SU, Lee HJ, Lee WS, Jeong JO, Park SD, Kang TS, Gwon HC. Culprit-Only Versus Immediate Multivessel Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction Complicating Advanced Cardiogenic Shock Requiring Venoarterial-Extracorporeal Membrane Oxygenation. J Am Heart Assoc. 2023 May 16;12(10):e029792. doi: 10.1161/JAHA.123.029792. Epub 2023 May 9.
PubMed 37158104Park IH, Jang WJ, Oh JH, Yang JH, Song YB, Hahn JY, Choi SH, Gwon HC, Ahn CM, Yu CW, Kim HJ, Bae JW, Kwon SU, Lee HJ, Lee WS, Jeong JO, Park SD. Non-culprit left main coronary artery disease in acute myocardial infarction complicated by cardiogenic shock. PLoS One. 2023 Mar 30;18(3):e0276711. doi: 10.1371/journal.pone.0276711. eCollection 2023.
PubMed 36996239
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMart Angioplasty Research Team: A Multi-center, Open, REtrospective and Prospective Observational Study to Investigate Clinical oUtcomes and Efficacy of Left Ventricular Assist Device for Korean Patients With Cardiogenic Shock : RESCUE
- ClinicalTrials.gov ID
- NCT02985008
- Acronym / sponsor ID
- SMART-RESCUE / 2016-03-130
- Conditions
- Shock, Cardiogenic
- Keywords
- Shock, IVBP, ECMO, In hospital death
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Jeong Hoon YangUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 7 Dec 2016 (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.
Retrospectively and prospectively enrolled patients with cardiogenic shock in domestic manifolds and investigated the current state of treatment and clinical features of cardiogenic shock in Koreans and identified the factors that could improve the prognosis and the use of IABP and ECMO And to investigate its therapeutic effect.
Detailed description
- The selection / exclusion criteria for persons with cardiogenic shock should be verified by medical records from January 1, 2014 before the approval date of each institution's clinical trial screening committee.
- If a cardiogenic shock to the selection criteria is found in the emergency room, general ward, or intensive care unit of the participating institutions, enroll in this study and fill in the information according to the e-CRF.
- After 1, 6 and 12 months, visit the hospital for examination and procedures. The person in charge of the examination or the delegate of the examiner may follow the person by telephone or an outpatient visit.
Study design
- Observational model
- Cohort
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Total: 1,000 * Cardiogenic shock group with inserted IABP, ECMO : 400 * Cardiogenic shock group without inserted IABP, ECMO : 600
Key inclusion criteria (5 listed)
- 19 years old or older
- ① Systolic blood pressure is less than 90mmHg for more than 30 minutes despite the fluid therapy, or Use of pressure boosting agents is necessary.
- ② Peripheral hypopnea (cold skin, urine less than 30 cc per hour, impaired consciousness, lactate ≥2.0 mmol / l) or a person with pulmonary edema.
- Causes of cardiogenic shock include acute myocardial infarction (including in coronary intervention), cardiomyopathy, myocarditis, pulmonary embolism, refractory ventricular tachycardia, shock during coronary intervention.
- Those voluntarily consenting to the medical records and the data necessary for the study during the entire study period.
Key exclusion criteria (4 listed)
- Other causes except for cardiogenic shock (low blood pressure, septic, obstructive shock)
- Shock with cardiac arrest outside the hospital
- People with allergic reactions to anticoagulants such as heparin.
- Those who refused active treatment.
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
In hospital death
Time frame: for 1 year
7 secondary outcomes
Death in 28days
Time frame: 28days
Death in 1 year
Time frame: 1 year
Death, myocardial infarction, stroke, re-admission due to heart failure during follow-up.
Time frame: 1 year
Number of days of intensive care unit Number of days of intensive care unit
Time frame: 1 year
hospitalization days
Time frame: 1 year
Lactate 24 hour clearance
Time frame: 1 year
Successful removal of left ventricular assist device (IABP, ECMO)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2016.
- Background: PubMed 20610640Thiele H, Allam B, Chatellier G, Schuler G, Lafont A. Shock in acute myocardial infarction: the Cape Horn for trials? Eur Heart J. 2010 Aug;31(15):1828-35. doi: 10.1093/eurheartj/ehq220. Epub 2010 Jul 7.
- Background: PubMed 24011548Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J, de Waha A, Richardt G, Hennersdorf M, Empen K, Fuernau G, Desch S, Eitel I, Hambrecht R, Lauer B, Bohm M, Ebelt H, Schneider S, Werdan K, Schuler G; Intraaortic Balloon Pump in cardiogenic shock II (IABP-SHOCK II) trial investigators. Intra-aortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock (IABP-SHOCK II): final 12 month results of a randomised, open-label trial. Lancet. 2013 Nov 16;382(9905):1638-45. doi: 10.1016/S0140-6736(13)61783-3. Epub 2013 Sep 3.
- Background: PubMed 25863737Rousse N, Juthier F, Pincon C, Hysi I, Banfi C, Robin E, Fayad G, Jegou B, Prat A, Vincentelli A. ECMO as a bridge to decision: Recovery, VAD, or heart transplantation? Int J Cardiol. 2015;187:620-7. doi: 10.1016/j.ijcard.2015.03.283. Epub 2015 Mar 20.
- Background: PubMed 25828345Napp LC, Brehm M, Kuhn C, Schafer A, Bauersachs J. Heart against veno-arterial ECMO: Competition visualized. Int J Cardiol. 2015;187:164-5. doi: 10.1016/j.ijcard.2015.03.311. Epub 2015 Mar 21. No abstract available.
- Derived from this study: PubMed 40537419Park IH, Kim CH, Jang WJ, Oh JH, Lee WS, Yang JH, Gwon HC. Sex-Specific Differences in Management and Outcomes of Cardiogenic Shock Patients With and Without Ischemic Cardiomyopathy. Korean Circ J. 2025 Sep;55(9):795-809. doi: 10.4070/kcj.2024.0440. Epub 2025 May 28.
- Derived from this study: PubMed 40097285Kim O, Hong D, Choi KH, Lee JM, Park TK, Song YB, Hahn JY, Choi SH, Cho YH, Gwon HC, Yang JH. Sex Differences in Patients With Cardiogenic Shock Receiving Venoarterial Extracorporeal Membrane Oxygenation. Korean Circ J. 2025 Jun;55(6):541-551. doi: 10.4070/kcj.2024.0330. Epub 2025 Feb 10.
- Derived from this study: PubMed 39855461Cha JH, Choi KH, Ahn CM, Yu CW, Park IH, Jang WJ, Kim HJ, Bae JW, Kwon SU, Lee HJ, Lee WS, Jeong JO, Park SD, Park TK, Lee JM, Song YB, Hahn JY, Choi SH, Gwon HC, Yang JH. Machine learning prediction of in-hospital mortality and external validation in patients with cardiogenic shock: the RESCUE score. Rev Esp Cardiol (Engl Ed). 2025 Aug;78(8):707-716. doi: 10.1016/j.rec.2025.01.003. Epub 2025 Jan 22. English, Spanish.
- Derived from this study: PubMed 38720697Jung S, Jang WJ, Lee WS, Park IH, Oh JH, Yang JH, Gwon HC, Ahn CM, Yu CW, Kim HJ, Bae JW, Kwon SU, Lee HJ, Jeong JO, Park SD. Seasonal variation and prognosis in patients with acute myocardial infarction complicated by cardiogenic shock. Heliyon. 2024 Apr 24;10(9):e30078. doi: 10.1016/j.heliyon.2024.e30078. eCollection 2024 May 15.
- Derived from this study: PubMed 38701179Hong D, Choi KH, Ahn CM, Yu CW, Park IH, Jang WJ, Kim HJ, Bae JW, Kwon SU, Lee HJ, Lee WS, Jeong JO, Park SD, Park TK, Lee JM, Song YB, Hahn JY, Choi SH, Gwon HC, Yang JH. Clinical significance of residual ischaemia in acute myocardial infarction complicated by cardiogenic shock undergoing venoarterial-extracorporeal membrane oxygenation. Eur Heart J Acute Cardiovasc Care. 2024 Jul 24;13(7):525-534. doi: 10.1093/ehjacc/zuae058.
- Derived from this study: PubMed 38491111Jang WJ, Park IH, Oh JH, Choi KH, Song YB, Hahn JY, Choi SH, Gwon HC, Ahn CM, Yu CW, Kim HJ, Bae JW, Kwon SU, Lee HJ, Lee WS, Jeong JO, Park SD, Yang JH. Efficacy and safety of durable versus biodegradable polymer drug-eluting stents in patients with acute myocardial infarction complicated by cardiogenic shock. Sci Rep. 2024 Mar 15;14(1):6301. doi: 10.1038/s41598-024-56925-2.
- Derived from this study: PubMed 38362865Jeong JH, Kook H, Lee SH, Joo HJ, Park JH, Hong SJ, Kim MN, Park SM, Jung JS, Yang JH, Gwon HC, Ahn CM, Jang WJ, Kim HJ, Bae JW, Kwon SU, Lee WS, Jeong JO, Park SD, Lim SH, Lee J, Lee J, Yu CW. Prediction of In-Hospital Mortality for Ischemic Cardiogenic Shock Requiring Venoarterial Extracorporeal Membrane Oxygenation. J Am Heart Assoc. 2024 Feb 20;13(4):e032701. doi: 10.1161/JAHA.123.032701. Epub 2024 Feb 16.
- Derived from this study: PubMed 38072307Kim Y, Jang WJ, Park IH, Oh JH, Yang JH, Gwon HC, Ahn CM, Yu CW, Kim HJ, Bae JW, Kwon SU, Lee HJ, Lee WS, Jeong JO, Park SD. Prognostic effect of sex according to shock severity in patients with acute myocardial infarction complicated by cardiogenic shock. Hellenic J Cardiol. 2025 Mar-Apr;82:3-14. doi: 10.1016/j.hjc.2023.11.007. Epub 2023 Dec 10.
- Individual participant dataSharing planned: Undecided
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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.
Jeong Hoon Yang study chair
Samsung Medical Center
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 Shock, Cardiogenic, run by Jeong Hoon Yang at 1 site in South Korea.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 7 Dec 2016. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeong Hoon Yang (+82-10-4872-9433, jeonghoon.yang@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In hospital death (time frame: for 1 year). 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 NCT02985008, which also lists 23 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 7 Dec 2016.