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Heart FailureAIMI-HFNCT01288560

IMAGE-HF Project I-A: Cardiac Imaging in Ischemic Heart Failure (AIMI-HF)

A study testing Advanced cardiac imaging and Standard Cardiac Imaging in people with Heart Failure and Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation at 20 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Medical imaging is one of the fastest growing sectors in health care and increases in utilization underscore the need to ensure imaging technology is developed and used effectively. Evaluation of the clinical and economic impact of such imaging lags behind the technology development. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Advanced cardiac imaging and Standard Cardiac Imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,390 participants
Where
20 sitesin 5 countries
Study dates
Jan 2011to 4 Oct 2022
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

  • Age >18 years
  • Known or highly suspected coronary artery disease (CAD) documented by coronary angiography or by history of previous MI or evidence of moderate ischemia or scar based on prior imaging
  • LV dysfunction most likely attributable to ischemic heart disease with EF <45% measured by any acceptable means (echo, nuclear RNA, PET or SPECT perfusion, Angiography, Cardiac MR) within the previous 6 months AND NYHA class II-IV symptoms within the past 12 months.
  • OR
  • LV dysfunction most likely attributable to ischemic heart disease with EF ≤30% measured by any acceptable means (echo, nuclear RNA, PET or SPECT perfusion, Angiography, Cardiac MR) within the previous 6 months AND NYHA class I within the past 12 months

Who cannot join

  • Severe medical conditions that significantly affect the patient's outcome (eg. severe COPD, active metastatic malignancy) and would preclude revascularization.
  • < 4 weeks post ST segment elevation myocardial infarction (STEMI)
  • Already identified as not suitable for revascularization;
  • Emergency revascularization indicated
  • Severe valvular heart disease requiring surgery
  • Contraindications to CMR (eg metallic implant, claustrophobia, renal failure (GFR <30 ml/min/1.73m2),). However patients with permanent pacemakers or implanted defibrillators or GFR <30 ml/min/1.7m2, will be randomized only to standard imaging (SPECT) versus PET or entered into the registry if only 1 modality is available
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  • Pregnancy
  • Potential for non compliance to tests involved in this protocol
  • Incapacity to provide informed consent

Trial locations and contacts

20 sites in 5 countries.

20 sites in 5 countries

Canada13 sites

  • University of Calgary

    Calgary, Alberta

  • University of Alberta

    Edmonton, Alberta

  • Dalhousie University

    Halifax, Nova Scotia

  • McMaster University

    Hamilton, Ontario

  • London Health Sciences Centre

    London, Ontario

  • Montreal Heart Institute

    Montreal, Quebec

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7

  • University of Laval

    Québec, Quebec

  • Université de Sherbrooke

    Sherbrooke, Quebec

  • St. Michael's Hospital

    Toronto, Ontario

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario

  • Providence Health

    Vancouver, British Columbia

  • University of Manitoba

    Winnipeg, Manitoba

Other trials in Canada

Finland3 sites

  • Helsinki University Central Hospital,

    Helsinki

  • University of Kuopio

    Kuopio

  • University of Turku

    Turku

Other trials in Finland

Argentina2 sites

  • Diagnostico Maipu por Imagenes

    Buenos Aires

  • Diagnostico Medico Orono

    Rosario

Other trials in Argentina

United States1 site

  • Brigham and Women's Hospital

    Boston, Massachusetts

Other trials in United States

Brazil1 site

  • Quanta Diagnóstico e Terapia

    Curitiba

Other trials in Brazil

About this study

Official title: Alternative Imaging Modalities in Ischemic Heart Failure (AIMI-HF) Project I-A of Imaging Modalities to Assist With Guiding Therapy and the Evaluation of Patients With Heart Failure (IMAGE-HF)

Medical imaging is one of the fastest growing sectors in health care and increases in utilization underscore the need to ensure imaging technology is developed and used effectively. Evaluation of the clinical and economic impact of such imaging lags behind the technology development. Heart failure (HF) represents the final common pathway for most forms of heart disease and morbidity and mortality remain high. There is a need to identify imaging approaches that have a positive impact on therapy decisions, patient outcomes and costs. As well as standard methods to evaluate new and emerging techniques to better test their potential in a clinical management setting.

PRIMARY OBJECTIVES: to compare the effect of HF imaging strategies on the composite clinical endpoint of cardiac death, MI, resuscitated cardiac arrest and cardiac re-hospitalization (WHF, ACS, arrhythmia). Patients with an ischemic heart disease (IHD) etiology will follow HF imaging strategy algorithms according to the question(s) asked by the physicians (is there ischemia and/or viability), in agreement with their local practices for standard and alternative imaging.

Read more

SECONDARY OBJECTIVES:

  1. To evaluate the effect of imaging modalities within and between the imaging subgroups (advanced (CMR and PET), PET, MRI and standard (SPECT)) on the primary and secondary outcomes in patients being evaluated either for viability and/or ischemia.
  2. To evaluate the impact of adherence to recommendations between modalities on outcomes in patients being evaluated for either viability or ischemia.
  3. To compare the effect of HF imaging strategies on:
  4. The incidence of revascularization procedures (PCI, CABG, none) and the interaction of the imaging strategy and types of revascularization on outcomes
  5. LV remodeling: LV volumes, LVEF,
  6. HF symptoms, NYHA class
  7. QOL (MLHFQ, the EQ5D)
  8. The evolution of serum prognostic markers in HF (e.g. BNP, RDW, hs-cTnT, hs-CRP, ST2)
  9. Health economics: Costs estimated through regression analysis and cost effectiveness assessed through decision modeling.
  10. The safety of imaging tests measured by cumulative radiation, adverse reactions to imaging contrast agents and stress testing agents will also be determined.
  11. The evolution of renal function (eGFR) and LV remodeling-associated biomarkers (e.g. PIIINP, OPN).
  12. Event rates of each component of the composite endpoint as well as the combined endpoint of CV death and HF hospitalization
  13. All-cause mortality
Read the detailed description

Among patients with coronary artery disease and HF, mortality rates range from 10-60% at 1 year. Many trials have demonstrated benefit of revascularization in patients with ischemic heart disease (IHD) and LV dysfunction. Some criteria, such as severe angina or left main coronary artery stenosis may indicate the need for surgical therapy for HF patients; however, a large number of patients fall into a gray zone without clear evidence for benefit from surgical intervention. The need remains for approaches that can help better define and select the HF patients most likely to benefit from revascularization; which could be either surgical or percutaneous intervention.

Increasingly over the past three decades, information describing cardiac structure, perfusion, hemodynamics, and metabolism obtained from noninvasive cardiac imaging studies has been used to guide management decisions for patients with HF.

AIMI-HF is part of a large international team grant IMAGE-HF (Imaging Modalities to Assist with Guiding therapy and the Evaluation of patients with Heart Failure) involving 3 parallel trials addressing the role of imaging in HF patients according to HF etiology.

Primary Hypothesis of AIMI-HF:

In patients with HF due to IHD with LVEF less than or equal to 45%, a management algorithm that applies alternative advanced imaging strategies (PET or CMR) achieves a better clinical outcome measured as the composite clinical endpoint (CCE) of cardiac death, MI, resuscitated cardiac arrest and cardiac re-hospitalization (WHF, ACS, arrhythmia) than an approach with "standard care".

Secondary Hypotheses of AIMI-HF:

  1. Compared to standard care, in patients with HF due to IHD with LVEF ≤ 45%, a management algorithm that applies alternative advanced imaging modalities (PET or CMR) achieves: a) more efficient use of revascularization procedures with similar complication rates than standard care imaging strategies b) better LV remodeling (including favorable evolution of serum markers associated with LV remodeling e.g. PIIINP, OPN) c) better HF and angina symptom reduction, d) better QoL, measured using MLHFQ and EQ5D, e) more favorable evolution of selected serum markers of prognosis in HF (e.g. BNP, RDW, hs-cTnT, hs-CRP), f) is economically attractive in patients with HF due to IHD with LVEF<45%, g) reduced event rates of each components of composite endpoint; h) all-cause mortality. ii) In patients with HF due to IHD with LVEF ≤ 45%, a HF management algorithm that applies PET or one that applies MRI, achieves a better primary composite clinical endpoint (CCE) and secondary outcomes compared to one that applies standard of care in patients assessed for ischemia and/or in patients assessed for viability. iii) In patients with HF due to IHD with LVEF ≤ 45%, a HF management algorithm that applies PET achieves a better primary composite clinical endpoint (CCE) and secondary outcomes compared to one that applies CMR in patients assessed for ischemia and/or in patients assessed for viability. iii) Renal function impairment is a known independent predictor of cardiovascular events in HF. Renal function may influence revascularization decisions and its evolution could be modified by revascularization procedures.

Study design AIMI-HF is the IMAGE-HF Project 1-A trial; it is a prospective comparative effectiveness study to compare the effect of HF imaging strategies in patients with HF due to IHD. Eligible patients will have LV systolic dysfunction due to IHD where evaluation of ischemia or viability is relevant. Patients will be prospectively randomized to standard (SPECT) versus advanced (PET or CMR) imaging. Patients who meet inclusion criteria but cannot be randomized due to clinical management decisions, yet undergo standard or advanced imaging (SPECT, PET/CT or CMR), will be entered into a registry. Based on site screening logs, patients who could not be randomized, who met all other inclusion criteria and underwent standard or advanced imaging, will be retrospectively enrolled, from the date of original HREB approval, into the study as registry participants. Registry recruitment will be monitored to ensure as best as possible a balanced recruitment for each modality registry.

Being tested
Advanced cardiac imaging, Standard Cardiac Imaging
Keywords
medical imaging, heart failure, morbidity and mortality, PET/CT,CMR,SPECT, echo, coronary angiography, knowledge translation, cost effectiveness, quality of life, prospective comparative effectiveness clinical trial
Medical subject headings
Heart Failure, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Advanced cardiac imagingOther

    Also called Cardiac PET/CT Imaging, Cardiac magnetic Resonance Imaging

  • Standard Cardiac ImagingOther

    Also called SPECT

Study groups in NCT01288560
Study groupRoleWhat they receive
Advanced cardiac imaging (PET/CT or CMR)Active comparatorPatients will undergo cardiac imaging as evaluation of heart failure using 1 of the following alternate/advanced imaging modalities: Positron Emission Tomography (PET/CT), Cardiac Magnetic Resonance (CMR)
Receives: Other: Advanced cardiac imaging
Standard cardiac imaging (SPECT)Active comparatorPatients will undergo standard cardiac imaging procedures for evaluation of heart failure such as single photon emission computed tomography (SPECT).
Receives: Other: Standard Cardiac Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The time to event of the composite clinical endpoint.

    Primary analysis, the time-to-event of the composite clinical endpoint of cardiac death, MI, arrest and cardiac re-hospitalization (WHF, ACS, arrhythmia) will be compared between advanced (PET or CMR) vs standard care (SPECT). A competing risk analysis will be performed using non-cardiac death. Cumulative incidence function will be used in estimating the probability of the composite endpoints in each of advanced and standard groups. The sub-distribution hazard model (Fine and Gray) will be used to compare the cumulative incidence curves. The hazard ratio and associated 95 percent confidence interval will be calculated. To adjust for possible effects of confounding variables on survival between advanced and standard, the propensity scores generated on baseline patient factors (e.g. in/outpatient, NYHA class, HF, diabetes, atrial fibrillation, renal function, obesity), site factor and status of randomized versus registry will be also included in the competing risk multivariable model.

    Measured: From enrolment until date of death or up to 60 months

Secondary outcomes (14)

  1. The time to event of the composite clinical endpoint viability cohort.

    The time-to-event of the composite clinical endpoint of cardiac death, MI, arrest and cardiac re-hospitalization (WHF, ACS, arrhythmia) will be compared between advanced (PET or CMR) vs standard care (SPECT). A competing risk analysis will be performed using non-cardiac death. Cumulative incidence function will be used in estimating the probability of the composite endpoints in each of advanced and standard groups. The sub-distribution hazard model (Fine and Gray) will be used to compare the cumulative incidence curves. The hazard ratio and associated 95 percent confidence interval will be calculated. To adjust for possible effects of confounding variables on survival between advanced and standard, the propensity scores generated on baseline patient factors (e.g. in/outpatient, NYHA class, HF, diabetes, atrial fibrillation, renal function, obesity), site factor and status of randomized versus registry will be also included in the competing risk multivariable model.

    Measured: From enrolment until date of death or up to 60 months

  2. The time to event of the composite clinical endpoint ischemia cohort.

    The time-to-event of the composite clinical endpoint of cardiac death, MI, arrest and cardiac re-hospitalization (WHF, ACS, arrhythmia) will be compared between advanced (PET or CMR) vs standard care (SPECT). A competing risk analysis will be performed using non-cardiac death. Cumulative incidence function will be used in estimating the probability of the composite endpoints in each of advanced and standard groups. The sub-distribution hazard model (Fine and Gray) will be used to compare the cumulative incidence curves. The hazard ratio and associated 95 percent confidence interval will be calculated. To adjust for possible effects of confounding variables on survival between advanced and standard, the propensity scores generated on baseline patient factors (e.g. in/outpatient, NYHA class, HF, diabetes, atrial fibrillation, renal function, obesity), site factor and status of randomized versus registry will be also included in the competing risk multivariable model.

    Measured: From enrolment until date of death or up to 60 months

  3. The time to event of the composite clinical endpoint (PET vs MRI).

    The time-to-event of the composite clinical endpoint of cardiac death, MI, arrest and cardiac re-hospitalization (WHF, ACS, arrhythmia) will be compared between PET and MRI. A competing risk analysis will be performed using non-cardiac death. Cumulative incidence function will be used in estimating the probability of the composite endpoints in each of advanced and standard groups. The sub-distribution hazard model (Fine and Gray) will be used to compare the cumulative incidence curves. The hazard ratio and 95% confidence interval will be calculated. To adjust for possible effects of confounding variables on survival between advanced and standard, the propensity scores generated on baseline patient factors (e.g. in/outpatient, NYHA class, HF, diabetes, atrial fibrillation, renal function, obesity), site factor and status of randomized versus registry will be also included in the competing risk multivariable model. All will be considered separately for viability and ischemia imaging.

    Measured: From enrolment until date of death or up to 60 months

  4. Imaging modalities: Comparing PET and MRI vs SPECT modalities and for the components of the composite

    For the secondary analysis, comparing the PET and MRI vs SPECT modalities, potential confounding variables of the relationship between the imaging technologies and the primary endpoint will be assessed. In particular, propensity scores based on patient factors (e.g. in/outpatient, NYHA class, HF duration, diabetes, atrial fibrillation, renal function) and site factors (e.g. time-to-imaging, time-to-therapy) will be used in the analysis if necessary to adjust for potential differences between PET and MRI vs SPECT. A Cox proportional hazard models will be used to assess the occurrence of the endpoints between the imaging technologies (model will include a group indicator variable) adjusting for any pertinent baseline differences identified. The proportional hazards assumption underlying the Cox model will be assessed. Analyses will be considered separately for viability and ischemia imaging.

    Measured: From enrolment until date of death or up to 60 months

  5. Imaging modalities: Comparing PET vs SPECT modalities and for the components of the composite

    For the secondary analysis, comparing the PET vs SPECT modalities, potential confounding variables of the relationship between the imaging technologies and the primary endpoint will be assessed. In particular, propensity scores based on patient factors (e.g. in/outpatient, NYHA class, HF duration, diabetes, atrial fibrillation, renal function) and site factors (e.g. time-to-imaging, time-to-therapy) will be used in the analysis if necessary to adjust for potential differences between PET vs SPECT. A Cox proportional hazard models will be used to assess the occurrence of the endpoints between the imaging technologies (model will include a group indicator variable) adjusting for any pertinent baseline differences identified. The proportional hazards assumption underlying the Cox model will be assessed. Analyses will be considered separately for viability and ischemia imaging.

    Measured: From enrolment until date of death or up to 60 months

  6. Imaging modalities: Comparing MRI vs SPECT modalities for the components of the composite

    For the secondary analysis, comparing the MRI vs SPECT modalities, potential confounding variables of the relationship between the imaging technologies and the primary endpoint will be assessed. In particular, propensity scores based on patient factors (e.g. in/outpatient, NYHA class, HF duration, diabetes, atrial fibrillation, renal function) and site factors (e.g. time-to-imaging, time-to-therapy) will be used in the analysis if necessary to adjust for potential differences between MRI vs SPECT. A Cox proportional hazard models will be used to assess the occurrence of the endpoints between the imaging technologies (model will include a group indicator variable) adjusting for any pertinent baseline differences identified. The proportional hazards assumption underlying the Cox model will be assessed. Analyses will be considered separately for viability and ischemia imaging.

    Measured: From enrolment until date of death or up to 60 months

  7. Imaging modalities: Comparing PET vs CMR for the components of the composite

    For the secondary analysis, comparing the PET vs CMR modalities, potential confounding variables of the relationship between the imaging technologies and the primary endpoint will be assessed. In particular, propensity scores based on patient factors (e.g. in/outpatient, NYHA class, HF duration, diabetes, atrial fibrillation, renal function) and site factors (e.g. time-to-imaging, time-to-therapy) will be used in the analysis if necessary to adjust for potential differences between PET and CMR. A Cox proportional hazard models will be used to assess the occurrence of the endpoints between the imaging technologies (model will include a group indicator variable) adjusting for any pertinent baseline differences identified. The proportional hazards assumption underlying the Cox model will be assessed. The secondary outcomes will be analyzed in a similar fashion. Analyses will be considered separately for viability and ischemia imaging.

    Measured: From enrolment until date of death or up to 60 months

  8. Revascularization rates between advanced and standard modalities

    A i) Revascularization rates (PCI \&CABG) chi-square tests will be used to compare the advanced and standard imaging technologies; logistic regression analysis will be used for adjusting any pertinent baseline differences identified. Analyses will be considered separately for viability and ischemia imaging.

    Measured: 3, 12 and 24 months

  9. HF symptoms between advanced and standard modalities

    A ii) HF symptoms (NYHA class) chi-square tests will be used to compare the advanced and standard imaging technologies; logistic regression analysis will be used for adjusting any pertinent baseline differences identified. Analyses will be considered separately for viability and ischemia imaging.

    Measured: 3, 12 and 24 months

  10. Event rates between advanced and standard modalities

    A iii) Event rates of each component of the composite endpoint, combination of CV death and HF hospitalization and all cause mortality chi-square tests will be used to compare the advanced and standard imaging technologies; logistic regression analysis will be used for adjusting any pertinent baseline differences identified. Analyses will be considered separately for viability and ischemia imaging.

    Measured: 3, 12 and 24 months

  11. LVEF change over time

    B i) Left ventricular ejection fraction change over time; an analysis of variance will be used to compare trends over time between the advanced and standard technologies. Analysis of covariance will be used for adjusting any pertinent baseline differences identified. Analyses will be considered separately for viability and ischemia imaging.

    Measured: 3, 12 and 24 months

  12. LV volumes change over time

    B ii)Left ventricular volumes change over time: analysis of variance will be used to compare trends over time between the advanced and standard technologies. Analysis of covariance will be used for adjusting any pertinent baseline differences identified. Analyses will be considered separately for viability and ischemia imaging.

    Measured: 3, 12, 24 months

  13. Cardiac biomarkers change over time

    B iii) Cardiac biomarkers change over time analysis of variance will be used to compare trends over time between the advanced and standard technologies. Analysis of covariance will be used for adjusting any pertinent baseline differences identified. Analyses will be considered separately for viability and ischemia imaging.

    Measured: 3, 12, 24 months

  14. Quality of Life assessment change over time

    B iv) Quality of life measures (MLHFQ and EQ5D) change over time analysis of variance will be used to compare trends over time between the advanced and standard technologies. Analysis of covariance will be used for adjusting any pertinent baseline differences identified. Analyses will be considered separately for viability and ischemia imaging.

    Measured: 3, 12, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2011 (estimated)
  2. Study startJan 2011
  3. Primary completion31 Oct 2020
  4. Study completion4 Oct 2022

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,390 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01288560
Sponsor's protocol ID
Project I-A
Other IDs
CIF-99470
Acronym
AIMI-HF
Status last verified
Nov 2023
First submitted
19 May 2010
Last updated
29 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Paterson DI, OMeara E, Chow BJ, Ukkonen H, Beanlands RS. Recent advances in cardiac imaging for patients with heart failure. Curr Opin Cardiol. 2011 Mar;26(2):132-43. doi: 10.1097/HCO.0b013e32834380e7.

    PubMed 21297464

  • O'Meara E, Mielniczuk LM, Wells GA, deKemp RA, Klein R, Coyle D, Mc Ardle B, Paterson I, White JA, Arnold M, Friedrich MG, Larose E, Dick A, Chow B, Dennie C, Haddad H, Ruddy T, Ukkonen H, Wisenberg G, Cantin B, Pibarot P, Freeman M, Turcotte E, Connelly K, Clarke J, Williams K, Racine N, Garrard L, Tardif JC, DaSilva J, Knuuti J, Beanlands R; IMAGE HF investigators. Alternative Imaging Modalities in Ischemic Heart Failure (AIMI-HF) IMAGE HF Project I-A: study protocol for a randomized controlled trial. Trials. 2013 Jul 16;14:218. doi: 10.1186/1745-6215-14-218.

    PubMed 23866673

  • Mielniczuk LM, O'Meara E, Wiefels C, Chen L, Garrard L, White J, deKemp RA, Di Carli MF, Larose E, Paterson DI, Ezekowitz J, Kandolin RM, Wright G, Campisi R, Laine MK, Connelly K, Rajda M, Vitola JV, Lepage S, Hartikainen J, Chow B, Tavoosi A, Knuuti J, Wells GA, Beanlands RSB; IMAGE HF Investigators. The Alternative Imaging Modalities in Ischemic Heart Failure (AIMI-HF) Trial-IMAGE HF Project 1A. CJC Open. 2025 Jul 16;7(11):1423-1433. doi: 10.1016/j.cjco.2025.06.023. eCollection 2025 Nov.

    PubMed 41425785

Questions about this trial

What is this clinical trial studying?

A study testing Advanced cardiac imaging and Standard Cardiac Imaging in people with Heart Failure and Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation at 20 sites in 5 countries.

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 9 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 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Canada, Finland, Argentina, United States, Brazil. 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?

The time to event of the composite clinical endpoint. (time frame: From enrolment until date of death or up to 60 months). 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 NCT01288560, which also lists 3 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 29 Nov 2023.

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