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Completed Not applicable Interventional

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

ClinicalTrials.gov ID: NCT01288560

Public ClinicalTrials.gov record NCT01288560. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 5:17 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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. 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: 1. The incidence of revascularization procedures (PCI, CABG, none) and the interaction of the imaging strategy and types of revascularization on outcomes 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, ST2) 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). 9. Event rates of each component of the composite endpoint as well as the combined endpoint of CV death and HF hospitalization 10. All-cause mortality

Study identification

NCT ID
NCT01288560
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Enrollment
1,390 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 31, 2010
Primary completion
Oct 30, 2020
Completion
Oct 3, 2022
Last update posted
Nov 28, 2023

2011 – 2022

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Brigham and Women's Hospital Boston Massachusetts

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 19 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01288560, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 28, 2023 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01288560 live on ClinicalTrials.gov.

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