Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol. We have both interventional & observational types of clinical trials found on this site.
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).
The purpose of this study is to determine the frequency, characteristics, and consequences of vulnerable carotid artery plaques ipsilateral to an acute ischemic stroke or TIA in the territory of the internal carotid artery.
Subjects in this research study have Coronary Artery Disease (CAD). This occurs when there
is a build-up of fatty material in the wall of the heart arteries that causes narrowing of
the arteries. This could lead to chest pain, a heart attack, weakening of the heart and/or
permanent damage to the heart. As part of their normal routine care, subjects had or will
have a Percutaneous Coronary Intervention (PCI) to restore the blood flow in the arteries of
their heart. During a PCI procedure, pictures are taken of the arteries before and after the
treatment of the narrowing in the arteries. These pictures are acquired through angiography
which is a way to produce X-ray pictures of the inside of arteries.
After a PCI procedure, there is a possibility for narrowing of the arteries to return. The likelihood of this happening can be greatly reduced by lifestyle changes and adhering to heart medication regimens. It is part of normal, routine care for CAD patients to be given written and verbal information on how to lead a heart healthy lifestyle and to take heart medications properly.
In this research study, the investigators will show half of the patients their before and after images of their heart arteries where the narrowing occurred and was treated. The other half of the patients will not be shown these images. Both groups will still receive information about lifestyle and medications as part of their normal, routine care. At the end of this study, the investigators will compare both groups to see if there are any differences in making lifestyle changes and taking heart medications properly. Additionally, the investigators would also like to see if there are any resulting differences in the amount of hearts attacks or other heart related medical events.