(Press-News.org) Results of the interim analyses performed after 12 months in the first 111 patients enrolled in phase II Cool AMI trial evaluating safety and effectiveness of systemic therapeutic hypothermia as an adjunctive therapy in anterior STEMI undergoing PCI as compared to PCI only. Analyses showed significant differences among treatment groups, including longer randomization-to-balloon time and total ischemic time in treatment arm, justifying premature trial discontinuation.
Therapeutic mild systemic hypothermia, when achieved before reperfusion of the infarct related vessel, has shown to limit infarct size in experimental animal models. Despite encouraging initial in vivo results, several prior RCTs reported overall neutral effects. A potential advantage of hypothermia was detected in early presenters with anterior STEMI cooled prior to reperfusion.
Safety of this approach in anterior STEMI patients was initially tested in the COOL AMI EU pilot phase I trial, which results were previously presented at EUROPCR 2017 and published in Eurointervention.
The COOL AMI EU pivotal trial, is an industry initiated, multicenter, prospective, interventional, randomized-controlled phase II trial with a 1:1 randomization protocol comparing systemic therapeutic hypothermia in patients with recent onset anterior STEMI (< 4.5 h from symptoms onset) cooled before and after primary PCI as compared to primary PCI only. Mild therapeutic hypothermia has been achieved with ZOLL Proteus Intra Vascular Temperature Management
system via fast injection of up to 1 litre cold saline through a catheter inserted via the femoral vein into the inferior vena cava reaching a mean body temperature of 33° C during treatment.
Primary efficacy endpoint was set as a relative reduction of 20% in mean anterior myocardial infarct size (as % left ventricular mass) determined by cardiac magnetic resonance imaging at 4-6 days post-infarct in the cooling + PCI arm as compared to the PCI only arm.
The secondary safety endpoint was defined as a composite of cardiac death, myocardial infarction and clinically-indicated target lesion revascularization at 30 day follow-up. According to the statistical analysis plan, 500 patients were expected to be enrolled to detect a relative reduction of 20% in mean infarct size in the treatment group. Interim analyses were pre-specified as per protocol.
During the LBT sessions of the upcoming EUROPCR 2021 congress, results of the interim analyses performed at 12 months after enrolment of 111 patients (58 treatment arm, 52 controls) were presented by Dr. M Noc (Ljubljana, Slovenia). The interim analysis led to premature, sponsor promoted, trial discontinuation.
Trialists observed significant differences among treatment groups, including longer randomization-to-balloon time (61±21 vs 32±18 minutes, p END
Cool AMI EU pivotal trial final results after trial discont. following ad interim analysis
Cool AMI EU is a phase II Randomized Clinical Trial evaluating systemic mild hypothermia as an adjunctive therapy to primary PCI in patients with anterior STEMI.
2021-05-18
ELSE PRESS RELEASES FROM THIS DATE:
A new meta-analysis supports elective revascularization and medical therapy
2021-05-18
The ISCHEMIA trial found no significant difference between an invasive vs. a conservative strategy in patients with chronic coronary syndromes and moderate to severe ischemia at a mean of 3.2 years. However, the cumulative difference in the estimates of cardiac death between the invasive and conservative strategies tended to increase numerically over time (e.g., 0.3% in favor of the invasive strategy at 2 years and 1.3% at 5 years). Because the ISCHEMIA trial was not powered for cardiac mortality and did not focus on long-term follow-up, the rationale for a meta-analysis emerged.
At EuroPCR 2021, Navarese and colleagues present the results of a new meta-analysis of revascularization plus medical therapy versus medical therapy alone. A total of 19,806 patients with chronic coronary syndromes ...
World first concept for rechargeable cement-based batteries
2021-05-18
Imagine an entire twenty storey concrete building which can store energy like a giant battery. Thanks to unique research from Chalmers University of Technology, Sweden, such a vision could someday be a reality. Researchers from the Department of Architecture and Civil Engineering recently published an article outlining a new concept for rechargeable batteries - made of cement.
The ever-growing need for sustainable building materials poses great challenges for researchers. Doctor Emma Zhang, formerly of Chalmers University of Technology, Sweden, joined Professor Luping Tang's research group several years ago to search for the building materials of the future. Together they have now succeeded in developing a world-first ...
'We're playing Moneyball with building assets'
2021-05-18
Researchers have developed a tool to help governments and other organizations with limited budgets spend money on building repairs more wisely.
The new tool uses artificial intelligence (AI) and text mining techniques to analyze written inspection reports and determine which work is most urgently needed.
"Those assessments are now largely subjective, the opinions of people based on experience and training," said Kareem Mostafa, an engineering PhD student at the University of Waterloo who led the project. "We're using actual data on buildings to make spending decisions more objective."
Researchers looked at inspection reports on the roofs of 400 schools managed by the Toronto District School Board. A computer ...
Uninsured cancer patients 60-64 face worse outcomes than Medicare beneficiaries aged 66-69
2021-05-18
MUSC Hollings Cancer Center lung cancer researcher Gerard Silvestri, M.D., found that a lack of insurance leads to worse cancer survival than for those with Medicare, in a paper published in the May issue of Health Affairs. This work, a joint effort between Silvestri and researchers at the American Cancer Society, highlights the current dire barrier in medical care: Many people cannot take advantage of the newer potentially lifesaving treatments due to the high costs.
Silvestri said the research began last year, inspired by the hotly debated topic of expanding Medicare ...
Fast, affordable solution proposed for transparent displays and semiconductors
2021-05-17
The Korea Institute of Machinery and Materials (KIMM) under the Ministry of Science and ICT developed a roll-based damage-free transfer technique that allows two-dimensional (2D) nanomaterials to be transferred into wafer scale without damage. The proposed technique has a variety of applications from transparent displays and semiconductors to displays for self-driving cars, and is expected to accelerate the commercialization of 2D nanomaterial-based high-performance devices.
Dr. Kwang-Seop Kim, principal researcher of the Department of Nano-Mechanics at KIMM, succeeded in developing a technique of transferring 2D nanomaterials, as thin as 1/50,000 of a strand of hair, to a substrate of at least 4 inches (approx. 10 cm) without damage.
The roll-based transfer is a process in ...
Caltech professor helps solve Hindenburg disaster
2021-05-17
On the evening of May 6, 1937, the largest aircraft ever built by mankind, a towering example of technological prowess, slipped through the stormy skies of New Jersey and prepared to land. The airship Hindenburg was nearing the end of a three-day voyage across the Atlantic Ocean from Frankfurt, Germany. It was a spectacle and a news event. Onlookers and news crews gathered to watch the 800-foot-long behemoth touch down.
And then, in one horrifying half minute, it was all over. Flames erupted from the airship's skin, fed by the flammable hydrogen gas that ...
Research reveals potential treatment to prevent obesity-driven liver damage
2021-05-17
One of the especially dangerous health risks of being extremely overweight occurs when an obese person begins to accumulate fat in their liver.
This condition--non-alcoholic fatty liver disease (NAFLD)--is the world's most common chronic liver disease and is the primary underlying cause for liver transplants in children and adults. Without such transplants, which are available to only a small percentage of patients, NAFLD over time can be fatal. In fact, (excluding alcohol-related liver damage) more than 30,000 people a year die from NAFLD.
For years, the primary way to treat NAFLD has ...
Study shows early preterm births can be decreased with DHA supplementation
2021-05-17
Early preterm births may be dramatically decreased with docosahexaenoic acid (DHA) supplements, with a dose of 1000 mg more effective for pregnant women with low DHA levels than the 200 mg found in some prenatal supplements, according to a study led by researchers from the University of Kansas and the University of Cincinnati and published today in EClinicalMedicine, a clinical journal of The Lancet. Early preterm birth, defined as birth before 34 weeks gestation, is a serious public health issue because these births result in the highest risk of infant mortality and child disability.
"This study tells us that pregnant women should be taking DHA," said Susan E. Carlson, Ph.D., professor of nutrition in the Department ...
COVID-19 monoclonal antibodies reduce risk of hospitalization and death
2021-05-17
PITTSBURGH, May 17, 2021 - Monoclonal antibodies, a COVID-19 treatment given early after coronavirus infection, cut the risk of hospitalization and death by 60% in those most likely to suffer complications of the disease, according to an analysis of UPMC patients who received the medication compared to similar patients who did not.
UPMC and University of Pittsburgh School of Medicine physician-scientists published the findings today in Open Forum Infectious Diseases, a journal of the Infectious Diseases Society of America. The study involved bamlanivimab, a monoclonal antibody that is now offered only in combination ...
Linguistic and biological diversity linked
2021-05-17
Cultural diversity -- indicated by linguistic diversity -- and biodiversity are linked, and their connection may be another way to preserve both natural environments and Indigenous populations in Africa and perhaps worldwide, according to an international team of researchers.
"The punchline is, that if you are interested in conserving biological diversity, excluding the Indigenous people who likely helped create that diversity in the first place may be a really bad idea," said Larry Gorenflo, professor of landscape architecture, geography and African studies, Penn State. "Humans are part of ecosystems and I hope this study will usher in a more committed effort to engage Indigenous people in conserving localities containing key biodiversity."
Gorenflo, ...
LAST 30 PRESS RELEASES:
nTIDE February 2025 Jobs Report: Labor force participation rate for people with disabilities hits an all-time high
Temperamental stars are distorting our view of distant planets
DOE’s Office of Science is now Accepting Applications for Office of Science Graduate Student Research Awards
Twenty years on, biodiversity struggles to take root in restored wetlands
Do embedded counseling services in veterinary education work? A new study says “yes.”
Discovery of unexpected collagen structure could ‘reshape biomedical research’
Changes in US primary care access and capabilities during the COVID-19 pandemic
Cardiometabolic trajectories preceding dementia in community-dwelling older individuals
Role of ELK3 in ferroptosis of rheumatoid arthritis fibroblast-like synoviocytes
Team of Prof. Woo Young Jang Department of Orthopedic Surgery, KU Anam Hospital wins the Best Paper Award from the Korean Musculoskeletal Tumor Society
Terasaki Institute for Biomedical Innovation announces recipients of inaugural Keith Terasaki Mid-Career Innovation Award
The impact of liver graft preservation method on longitudinal gut microbiome changes following liver transplant
Cardiovascular health risks continue to grow within Black communities, action needed
ALS survival may be cut short by living in disadvantaged communities
No quantum exorcism for Maxwell's demon (but it doesn't need one)
Balancing the pressure: How plant cells protect their vacuoles
Electronic reporting of symptoms by cancer patients can improve quality of life and reduce emergency visits
DNA barcodes and citizen science images map spread of biocontrol agent for control of major invasive shrub
Pregnancy complications linked to cardiovascular disease in the family
Pancreatic cancer immune map provides clues for precision treatment targeting
How neighborhood perception affects housing rents: A novel analytical approach
Many adults report inaccurate beliefs about risks and benefits of home firearm access
Air pollution impacts an aging society
UC Davis researchers achieve total synthesis of ibogaine
Building better biomaterials for cancer treatments
Brain stimulation did not improve impaired motor skills after stroke
Some species of baleen whales avoid attracting killer whales by singing too low to be heard
Wasteful tests before surgery: Study shows how to reduce them safely
UCalgary researchers confirm best approach for stroke in medium-sized blood vessels
Nationwide, 34 local schools win NFL PLAY 60 grants to help students move more
[Press-News.org] Cool AMI EU pivotal trial final results after trial discont. following ad interim analysisCool AMI EU is a phase II Randomized Clinical Trial evaluating systemic mild hypothermia as an adjunctive therapy to primary PCI in patients with anterior STEMI.