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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01288560
Other study ID # Project I-A
Secondary ID CIF-99470
Status Recruiting
Phase Phase 4
First received
Last updated
Start date January 2011
Est. completion date June 2019

Study information

Verified date May 2018
Source Ottawa Heart Institute Research Corporation
Contact Linda M. Garrard, RN, BScN
Phone 613-696-7000
Email lgarrard@ottawaheart.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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. The OVERALL OBJECTIVES of the IMAGE-HF trial are 1) to determine the impact of emerging imaging strategies, on relevant clinical outcomes and decision making in patients with HF; 2) to establish standardization quality assurance (QA) measures and central databases in order to achieve reliable outcome driven research; 3) to apply this as a platform for evaluation of new and emerging imaging biomarkers in HF.

Project I-A: The PRIMARY OBJECTIVE OF AIMI-HF is 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.

Secondary objectives of AIMI-HF To compare the effect of HF imaging strategies on

1. The incidence of revascularization procedures (PCI, CABG)

2. LV remodeling: LV volumes, LVEF

3. HF symptoms, NYHA class

4. QOL (MLHFQ, the EQ5D)

5. The evolution of serum prognostic markers in HF (e.g. BNP, RDW, hs-cTnT, hs-CRP)

6. Health economics: Costs estimated through regression analysis and cost effectiveness assessed through decision modeling.

7. The safety of imaging tests measured by cumulative radiation, adverse reactions to imaging contrast agents and stress testing agents will also be determined.

8. The evolution of renal function (eGFR) and LV remodeling-associated biomarkers (e.g. PIIINP, OPN).


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 Canadian team grant IMAGE-HF (Imaging Modalities to Assist with Guiding therapy and the Evaluation of patients with Heart Failure) involving 3 parallel randomized 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 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:

i) Compared to standard care, in patients with HF due to IHD with LVEF ≤ 45%, a management algorithm that applies alternative 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) and f) is economically attractive in patients with HF due to IHD with LVEF<45%.

ii) 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 (revascularizations, remodeling, QoL, Cost efficiency) compared to one that applies CMR.

iii) Renal function impairment is a known independent predictor of cardiovascular events in HF. Renal function may influence revascularisation decisions and its evolution could be modified by revascularisation 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 and 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 a balanced recruitment for each modality registry.


Recruitment information / eligibility

Status Recruiting
Enrollment 1511
Est. completion date June 2019
Est. primary completion date September 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria:

- 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

Exclusion criteria:

- 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

- Pregnancy

- Potential for non compliance to tests involved in this protocol

- Incapacity to provide informed consent

Study Design


Intervention

Other:
Advanced cardiac imaging

Standard Cardiac Imaging


Locations

Country Name City State
Argentina Diagnostico Maipu por Imagenes Buenos Aires
Argentina Diagnostico Medico Orono Rosario
Brazil Quanta Diagnóstico e Terapia Curitiba
Canada University of Calgary Calgary Alberta
Canada University of Alberta Edmonton Alberta
Canada Dalhousie University Halifax Nova Scotia
Canada McMaster University Hamilton Ontario
Canada London Health Sciences Centre London Ontario
Canada Montreal Heart Institute Montreal Quebec
Canada University of Ottawa Heart Institute Ottawa Ontario
Canada University of Laval Quebec City Quebec
Canada Université de Sherbrooke Sherbrooke Quebec
Canada St. Michael's Hospital Toronto Ontario
Canada Sunnybrook Health Sciences Centre Toronto Ontario
Canada Providence Health Vancouver British Columbia
Canada University of Manitoba Winnipeg Manitoba
Finland Helsinki University Central Hospital, Helsinki
Finland University of Kuopio Kuopio
Finland University of Turku Turku
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (3)

Lead Sponsor Collaborator
Ottawa Heart Institute Research Corporation Canadian Institutes of Health Research (CIHR), The Finnish Funding Agency for Technology and Innovation (TEKES)

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  Finland, 

References & Publications (2)

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. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The time to event of the composite clinical endpoint. For the 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 the advanced modality (PET or CMR) to an approach with standard care using SPECT imaging using survival analysis. Kaplan-Meier survival curves of the primary endpoint will be compared between the advanced and standard modalities with the log-rank test. In addition for the primary hypothesis, a SPECT registry will be considered in order to make the allocation between the advanced and standard modalities 1:1.
3, 12 and 24 months
Secondary Change in Left ventricular ejection fraction, NYHA symptom class, Quality of Life and related resource utilization For the secondary outcomes PCI, CABG, HF symptoms and 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. For the secondary outcomes LVEF, MLHFQ and EQ5D, 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. 3, 12 and 24 months
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