Risk of contrast-induced kidney injury is expected to be strongly correlated with exposure time. Studies on the excretion of iodinated contrast material are few and have mostly been carried out in patients with normal renal function. Although case wise reports of persistent renograms have been published, it is not known how long contrast is retained before excretion in patients with eGFR <30 mL/min/1.73m2, nor which of these patients are most susceptible to contrast retention. The current observational study aims to compare contrast elimination time and % contrast excretion in patients with eGFR <30 mL/min/1.73m2, to matched patients (for age, sex and contrast procedure type) with eGFR 30-59 and eGFR >=60 mL/min/1.73m2.

Start Date01 Nov 2097

Sponsor / Collaborator

Maastricht UMC+

NCT04598516 / WithdrawnNot ApplicableIIT

Maastricht Investigation of Renal Function in Absence of- and Post- Contrast in Patients With Estimated Glomerular Filtration Rate LEss Than 30mL/Min/1.73m2

Intravascular iodinated contrast administration has become crucial to modern medicine. Currently it is estimated that over 250 million injections are given each year worldwide during medical scans and interventions. An acute predefined increase in serum creatinine is considered an indicator of acute kidney injury (AKI). When such an acute increase in serum creatinine occurs within 5 days post-contrast in absence of another aetiology, it is assumed to be iodinated contrast administration induced acute kidney injury. For over 50 years now, acute kidney injury caused by intravascular administration of iodinated contrast material has been considered a leading cause of hospital-acquired renal failure. Contrast has been withheld in fear of kidney injury with misdiagnoses and delayed appropriate patient management as a result. Since 2018, it is now widely accepted that only patients with eGFR <30 mL/min/1.73m2 are at risk of renal injury after intravascular iodinated contrast material injection. However, no study to date has been able to distinguish acute kidney injury caused by iodinated contrast administration from that for which no causal link is established, and it is unsure a causal relationship exists. There are several studies, in attempts to evaluate the causal relationship between contrast exposure and nephrotoxicity, that found fluctuations in absence of contrast similar to those considered to be contrast-induced acute kidney injury. Similarly, it is unsure whether longer-term negative outcomes are inherent to the population studied or a result of contrast administration. However, most of these studies are observational and retrospective in nature. The issue with retrospective studies is that they often cannot control for confounders and therefore cannot give us causation, only association. On the other hand, prospective randomized controlled trials comparing intravascular iodinated contrast administration to no contrast are unlikely given evident ethical issues. The current prospective observational study proposes to use intra-patient comparisons of peak change in renal function during periods in absence of- and with contrast to elucidate the relationship between renal function and contrast administration in this population.

Start Date01 Nov 2097

Sponsor / Collaborator

Maastricht UMC+

NCT04597892 / WithdrawnNot ApplicableIIT

Efficacy of Point-of-care Creatinine Assays in Patients With eGFR <30ml/Min/1.73m2 in the Setting of Elective Procedures With Intravascular Iodinated Contrast

Point-of-care (POC) creatinine devices allow rapid measurement of creatinine levels and calculation of estimated glomerular filtration rate (eGFR) which give an indication of renal function. The focus of this assessment is to validate POC measurements to assess kidney function before intravascular iodinated contrast administration in patients with severe renal insufficiency (eGFR < 30 ml/min/1.73m2). It will be evaluated whether discrepancies between POC measurement values and values obtained from standard laboratory assays lie within an acceptable range using Bland-Altman analysis.

Start Date01 May 2097

Sponsor / Collaborator

Maastricht UMC+

100 Clinical Results associated with Contrast agents

100 Translational Medicine associated with Contrast agents

0 Patents (Medical) associated with Contrast agents

3,371

Literatures (Medical) associated with Contrast agents

31 Dec 2024·Renal Failure

Reduction in the risk of contrast-induced nephropathy using enhanced external counter-pulsation in patients with chronic kidney disease

Article

Author: Zeng, Chun-Mei ; Ling, Zheng ; Pan, Hong-Yu ; Liu, Ming ; Feng, Ying ; Zhao, Yan-Mei

OBJECTIVETo evaluate the efficacy of EECP in the prevention of contrast-induced nephropathy (CIN) in patients with chronic kidney disease (CKD).METHODSA prospective trial was undertaken in the participants. A total of 280 patients with an estimated glomerular filtration rate (eGFR) of <60 ml/min/1.73 m² who underwent percutaneous coronary artery procedures were enrolled and divided into two groups: the control group (n = 100) and the EECP group (n = 180). All patients received extracellular fluid volume expansion therapy with 0.9% normal saline, and patients in the EECP groups were also treated with EECP. The renal function indexes of the two groups were determined 48-72 h after coronary artery procedures.RESULTSIn the EECP group, the BUN and serum creatinine (Scr) after coronary artery procedures were significantly lower than those before coronary artery procedures (BUN: 8.4 ± 3.5 vs. 6.6 ± 2.7 mmol/L, p < 0.001; Scr: 151.9 ± 44.7 vs. 144.5 ± 48.3 μmol/L, p < 0.001), while the eGFR was significantly increased (43.6 ± 11.4 vs. 47.1 ± 13.9 ml/min/1.73 m², p < 0.001). The degree of Scr elevation was lower in the EECP group than in the control group (12.4 ± 15.0 vs. 20.9 ± 24.8 μmol/L, p = 0.026). Additionally, the EECP group had a lower incidence of post-procedures Scr elevation than the control group (36.5 vs. 48.0%, p = 0.042), a higher incidence of post-procedures eGFR elevation (62.2 vs. 48.0%, p = 0.021), and a lower risk of CIN (1.1 vs. 6.0%, p = 0.019).CONCLUSIONEECP therapy has a protective effect on renal function and can reduce the risk of CIN in patients with CKD.

01 Dec 2024·Thrombosis Research

Inferior vena cava contrast reflux grade is associated with a reduced cardiac index in acute pulmonary embolism

Article

Author: Mukherjee, Vikramjit ; Zhang, Robert S ; Zhang, Robert S. ; Elbaum, Lindsay ; Horowitz, James M ; Greco, Allison A. ; Alviar, Carlos L ; Yuriditsky, Eugene ; Horowitz, James M. ; Bernard, Samuel ; Alviar, Carlos L. ; Bangalore, Sripal ; Postelnicu, Radu ; Keller, Norma M. ; Hena, Kerry ; Keller, Norma M ; Zhang, Peter ; Greco, Allison A

BACKGROUND AND AIMSPatients with intermediate-risk pulmonary embolism (PE) commonly present with a significantly reduced cardiac index (CI). However, the identification of this more severe profile requires invasive hemodynamic monitoring. Whether inferior vena cava (IVC) contrast reflux, as a marker of worse right ventricular function, can predict invasive hemodynamics has not been explored.METHODSThis was a single-center retrospective study over a 3-year period of consecutive patients with PE undergoing mechanical thrombectomy and simultaneous pulmonary artery catheterization. CT pulmonary angiograms were reviewed, and contrast reflux was graded as no/minimal reflux (limited to the IVC) or substantial (opacification including hepatic veins) based on an established scale.RESULTSSubstantial contrast reflux was present in 29 of 85 patients (34 %) and associated with a lower CI (1.8 ± 0.4 L/min/m² v. 2.6 ± 1.0 L/min/m², p < 0.001), higher pulmonary artery systolic pressure (53.2 ± 19.5 mmHg v. 44.0 ± 12.1 mmHg, p = 0.025), and worse right ventricular systolic function. An IVC contrast reflux grade > 3 was a significant predictor for a CI ≤2.2 L/min/m² (OR: 22.5, 95 % CI: 4.8, 104.4, p < 0.001). Sensitivity, specificity, positive predictive value, and negative predictive value for substantial contrast reflux for a CI ≤2.2 L/min/m² were 62.6 %, 93.1 %, 94.6 %, and 56.2 %, respectively. These findings remained significant in a multivariable model and were similar when isolating for intermediate-risk patients (n = 72, 85 %).CONCLUSIONSThe degree of contrast reflux is highly specific for a reduced cardiac index in PE even when isolating for intermediate-risk patients. Real-time prediction of a hemodynamic profile may have added value in the risk-stratification of PE.

01 Dec 2024·IJC Heart & Vasculature

Comparison of the effects of contrast medium and low-molecular-weight dextran on coronary optical coherence tomographic imaging in relatively complex coronary lesions

Article

Author: He, Yong ; Wang, Hua ; Chen, Yong ; Zhou, Minggang ; Li, Chen ; Chen, Zhongxiu ; Zhang, Junyan

BackgroundOptical coherence tomography (OCT) has gained increasing popularity in coronary artery intervention due to its high resolution and excellent tissue correlation as a novel intravascular imaging modality. However, the current use of OCT requires contrast agent injection for imaging, and excessive use of contrast agents may adversely affect renal function, exacerbate cardiac burden, and even lead to contrast agent-induced nephropathy and heart failure. In recent years, several researchers have proposed the use of low molecular weight dextran (LMWD) as a substitute for contrast agents in OCT imaging because of its low toxicity, low cost, and wide availability. However, the inclusion of lesions in these studies is relatively simple, and the image quality criteria remain to be optimized.MethodsThis study included 26 patients with coronary artery disease who were scheduled for OCT imaging in a real-world clinical practice involving various complex lesions. All patients underwent two OCT examinations at the same vascular site, one each using contrast agent and LMWD. Both contrast media and LMWDs were infused by an autoinjector. The primary endpoint of the study was the average image quality score. Secondary endpoints included clear image length, clear image segments, minimum lumen area, average lumen area, and contrast-induced nephropathy, among others.ResultsIn terms of image clarity, the average image quality score was similar when comparing contrast media with LMWD (3.912 ± 0.175 vs. 3.769 ± 0.392, P = 0.071). The lengths of the clear images and the segments of the clear images were also similar between the two groups (50.97 ± 16.25 mm vs. 49.12 ± 18.15 mm, P = 0.110; 255.5 ± 81.29 vs. 250.5 ± 89.83, P = 0.095). Additionally, strong correlations were noted between the two flushing solutions regarding the minimum lumen area and mean lumen area. During their hospital stay, none of the patient exhibited deterioration in renal function, and no patient experienced any major adverse cardiovascular events.ConclusionsThe quality of coronary artery OCT imaging using LMWD may be comparable to that achieved with traditional contrast agents, even in real-world clinical practice involving various complex lesions. For high-risk patients, LMWD may serve as an excellent substitute for contrast agents in OCT examinations.

News (Medical) associated with Contrast agents

13 Sep 2024

·www.prnewswire.com

Zydus announces exclusive licensing and supply agreement for two Gadolinium based Magnetic Resonance Imaging (MRI) injectable, contrast agents in the US

AHMEDABAD, India, Sept. 13, 2024 /PRNewswire/ -- Zydus Lifesciences Ltd., a global innovation driven healthcare company announced that its wholly owned subsidiary, Zydus Lifesciences Global FZE has entered into an exclusive licensing and supply agreement with Viwit Pharmaceuticals (Viwit), an innovation driven biopharmaceutical and healthcare company, for gadobutrol injection (generic version of GADAVISTTM) and gadoterate meglumine injection (generic version of DOTAREM®) for the US market. As per the terms of the agreement, Viwit will be responsible for ANDA submission, manufacturing and supplying the generic versions of GADAVISTTM and DOTAREM®, following the receipt of requisite regulatory approval. Zydus will exclusively market, distribute, and sell these products in the US market. Both the products are Gadolinium based Magnetic Resonance Imaging (MRI) contrast agents and will be the first set of contrast agent products in Zydus' injectable portfolio for the US market. The total addressable market opportunity for gadobutrol injection is estimated at US$ 120 million, and for gadoterate meglumine injection at US$ 117 million in the US market (as per IQVIA MAT Jul - 2024). About Zydus Zydus Lifesciences Ltd. with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group has a significant presence in cancer related therapies and offers a wide range of solutions with cytotoxic, supportive & targeted drugs. The group employs over 27,000 people worldwide, including 1,400 scientists engaged in R & D, and is driven by its mission to unlock new possibilities in lifesciences through quality healthcare solutions that impact lives. The group aspires to transform lives through path-breaking discoveries. For more details visit About Viwit Pharmaceuticals Viwit is an innovation driven biopharmaceutical and healthcare company with integrated research and development, production and marketing systems. Viwit is committed to building a platform for pharmaceutical innovation and commercialization, and establishing an ecosystem that serves the healthcare needs of the general public. Viwit started as Boranes producing company and has evolved into a healthcare company offering API and Drug Product development and manufacturing as well as CDMO services. Viwit has three integrated product R&D centers, three cGMP US FDA inspected production facilities. By continuously improving the level, depth and scope of innovation, Viwit makes every effort to provide people with better health products and services, and to fulfil Viwit vision of "Innovation for a Better Life". For more details visit . Logo: SOURCE Zydus Lifesciences Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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11 Sep 2024

·www.drugs.com

Vision Impairment Contributes to Dementia Risk

WEDNESDAY, Sept. 11, 2024 -- The population-attributable fraction of dementia from vision impairments ranges from 4.9 to 19.0 percent, according to a study published online Sept. 5 in JAMA Ophthalmology . Jason R. Smith, from the Johns Hopkins Bloomberg School of Public Health in Baltimore, and colleagues estimated the contribution of vision impairments to dementia using data from the National Health and Aging Trends Study (2,767 community-dwelling Medicare beneficiaries aged 65 years and older). The researchers found that the population-attributable fraction of prevalent dementia from at least one vision impairment was 19.0 percent. The strongest attributable fraction among all impairments was seen for contrast sensitivity impairment (15.0 percent), followed by near acuity (9.7 percent) and distance acuity (4.9 percent). Population-level dementia-attributable fractions from at least one visual impairment were highest among subpopulations of participants aged 71 to 79 years (24.3 percent), female individuals (26.8 percent), and non-Hispanic White individuals (22.3 percent), with estimates consistent across educational strata. "While not proving a cause-and-effect relationship, these findings support inclusion of multiple objective measures of vision impairments, including contrast sensitivity and visual acuity, to capture the total potential impact of addressing vision impairment on dementia," the authors write. Several authors disclosed ties to relevant organizations.

20 Dec 2023

·www.prnewswire.com

Meilleur Technologies Inc. Announces Execution of Manufacturing Agreement with PharmaLogic for Production of the Next-Generation Amyloid PET Imaging Biomarker, NAV4694

KNOXVILLE, Tenn. and BOCA RATON, Fla., Dec. 20, 2023 /PRNewswire/ -- Meilleur Technologies Inc. (MTI) today announced it has signed an agreement with PharmaLogic Holdings Corporation ("PharmaLogic") granting PharmaLogic the rights to manufacture fluorine-18 [F18]NAV4694, a next-generation investigational imaging biomarker used in Positron Emission Tomography (PET) imaging studies to assess the status of amyloid plaque in the brain. Amyloid plaques are one of the pathological hallmarks of several neurodegenerative diseases, including Alzheimer's Disease (AD). Continue Reading Logo for Meilleur Technologies,. Under the terms of the agreement, PharmaLogic will manufacture [F18]NAV4694 for use in clinical trials at select United States-based radiopharmacies. "We are delighted that the NAV-694 clinical and research program will be supported by Pharmalogic's extensive PET manufacturing and dispensing expertise," said Rick Hiatt, President and CEO of Meilleur Technologies, Inc. "Meilleur is focused on enabling acceleration of technologies that have the potential to advance the fight against debilitating neurodegenerative disease. Additionally, we believe NAV4694 has unique properties that will prove useful in developing current and future therapeutic agents in neurodegenerative disease and are excited to add PharmaLogic to our growing network of pharmaceutical and academic partners. Our goal is to expand the availability of this novel investigational imaging agent to the broader scientific community." "PharmaLogic is pleased to partner with Meilleur Technologies furthering our commitment to help combat some of the world's most challenging diseases, including Alzheimer's Disease," said Steve Chilinski, CEO of PharmaLogic. About Meilleur Technologies, Inc. Meilleur's vision is to be the premier provider of imaging biomarkers for neurological pathologies, associated information technology and related tools to accelerate the development, approval, and adoption of effective therapies to treat neurodegenerative diseases. Meilleur's late-stage biomarker, NAV-4694, provides Pharma and Academic researchers with a 'best in class' second generation ß-Amyloid imaging biomarker capable of detecting and validating Disease Modifying Therapies with the highest possible precision and accuracy for determining the risk of Alzheimer's disease. About PharmaLogic PharmaLogic is a world-class North American contract development and manufacturing organization specializing in novel diagnostic imaging and therapeutic radiopharmaceuticals for the treatment of cancers and other diseases. In addition to an established and reliable network of radiopharmacies, PharmaLogic has decades of expertise in drug development from discovery, through manufacturing and commercialization. The Company seeks to take the lead in the advancement of radiopharmaceutical technology for the benefit of patients worldwide. For more information, visit: SOURCE PharmaLogic Holdings Corp

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