Study shows registry data could support clinical trials
Baseline data elements from DAPT Study strongly agree with CathPCI Registry data
2021-06-21
(Press-News.org) Data captured in NCDR registries is similar in quality, depth and granularity when compared to data captured through clinical trials, according to research in JACC: Cardiovascular Interventions that compared data from the DAPT Study to NCDR CathPCI Registry data. This is good news for streamlining data collection and supports recent efforts to standardize data elements and definitions used in clinical trials and registries.
"We found an overall high level of similarity in data between these two sources. This suggests that registries may also be suitable to support baseline data collection for many clinical studies," said senior study author Robert W. Yeh, MD, MSc, director of the Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology at the Beth Israel Deaconess Medical Center and associate professor of Medicine at Harvard Medical School. "Being able to leverage existing registries to provide data for clinical trials has the potential to greatly enhance the efficiency and lower the costs of conducting these important studies."
The researchers linked a group of Dual Antiplatelet Therapy (DAPT) Study patients to the NCDR CathPCI Registry and compared data elements for the same patients. All patients receiving percutaneous coronary intervention (PCI) with drug-eluting stents randomized in the DAPT Study who could be linked to the CathPCI Registry were included. Baseline patient and procedural characteristics were compared using data collected by two methods: reports submitted by DAPT Study investigators and site-reported data submitted to the CathPCI Registry.
Out of 8,864 DAPT Study patients, 5,743 (65%) were successfully matched to data in the CathPCI Registry. There was strong agreement with many data elements, including demographics and procedural characteristics. For some prior history and risk factors, there was more modest agreement and agreement was poor for clinical presentation. According to the researchers, most notably, angina was more likely to be classified as unstable in the CathPCI Registry versus the DAPT Study.
The results suggest that CathPCI Registry data could be used to support future clinical trials, decreasing the burden of data collection on sites participating in both trials and the registry. However, variables that could be considered more subjective, such as clinical presentation, would likely need to be defined more precisely. Future trials leveraging the CathPCI Registry would also need to ensure that the key data elements are suitable to answer key trial questions.
"Whether these findings generalize to other types of data in the CathPCI Registry or other clinical registries is unknown and remains a rich area for future inquiry," Yeh said. "Overall, however, the data are promising in pointing to an important mechanism to make clinical trials more feasible and less costly, helping to overcome one of the most significant barriers to clinical research."
The primary limitations of the study were the inability to link all patients. In addition, how these results would have fared for other clinical trials is unknown.
INFORMATION:
The American College of Cardiology envisions a world where innovation and knowledge optimize cardiovascular care and outcomes. As the professional home for the entire cardiovascular care team, the mission of the College and its 54,000 members is to transform cardiovascular care and to improve heart health. The ACC bestows credentials upon cardiovascular professionals who meet stringent qualifications and leads in the formation of health policy, standards and guidelines. The College also provides professional medical education, disseminates cardiovascular research through its world-renowned JACC Journals, operates national registries to measure and improve care, and offers cardiovascular accreditation to hospitals and institutions. For more, visit acc.org.
The Journal of the American College of Cardiology ranks among the top cardiovascular journals in the world for its scientific impact. JACC is the flagship for a family of journals--JACC: Cardiovascular Interventions, JACC: Cardiovascular Imaging, JACC: Heart Failure, JACC: Clinical Electrophysiology, JACC: Basic to Translational Science, JACC: Case Reports, JACC: CardioOncology and JACC: Asia--that prides themselves in publishing the top peer-reviewed research on all aspects of cardiovascular disease. Learn more at JACC.org.
ELSE PRESS RELEASES FROM THIS DATE:
2021-06-21
The use of statin therapy in adults 65 years old or older is not associated with incident dementia, mild cognitive impairment (MCI) or decline in individual cognition domains, according to a study published in the Journal of the American College of Cardiology (JACC).
Cognitive decline and dementia are major health concerns in older individuals, affecting about 10% of people over 60 years old. Statins are used to reduce low-density lipoprotein cholesterol, or bad cholesterol, thus they are a fundamental treatment for prevention of primary and secondary cardiovascular disease (CVD) events. The Food and Drug Administration released a warning in 2012 about cases of apparent short-term ...
2021-06-21
It's a treasure trove of data: the global geodatabase of vegetation plots "sPlotOpen" is now freely accessible. It contains data on vegetation from 114 countries and from all climate zones on Earth. The database was compiled by an international team of researchers led by Martin Luther University Halle-Wittenberg (MLU), the German Centre for Integrative Biodiversity Research (iDiv) and the French National Centre for Scientific Research (CNRS). Researchers around the world finally have a balanced, representative dataset of the Earth's vegetation at their disposal, as the team reports in the journal Global Ecology & Biogeography.
Global issues and questions require global answers. "If we want to understand or predict how climate ...
2021-06-21
June 21, 2021 -- A new study published in Nutrients investigated the effect of increased dietary potassium from a whole food source--baked/boiled potatoes and baked French fries--or a potassium supplement on blood pressure and other cardiovascular disease risk factors compared to a 'typical American' control diet (lower potassium intake) among 30 pre-hypertensive to hypertensive men and women. Results showed that including baked/boiled potato consumption as part of a typical American diet had the greatest benefit on reducing sodium retention, even more than the supplement, and resulted ...
2021-06-21
COVID-19 therapies made from antibodies often are given to patients who are at high risk of severe illness and hospitalization. However, there have been nagging questions about whether such antibody therapies retain their effectiveness as worrisome new virus variants arise.
New research at Washington University School of Medicine in St. Louis suggests that many, but not all, therapies made from combinations of two antibodies are effective against a wide range of variants of the virus. Further, combination therapies appear to prevent the emergence of drug resistance.
The study, in mice and hamsters, tested all single and combination antibody-based therapies authorized for emergency use ...
2021-06-21
HOUSTON - (June 21, 2021) - Diamond may be just a phase carbon goes through when exposed to a flash of heat, but that makes it far easier to obtain.
The Rice University lab of chemist James Tour is now able to "evolve" carbon through phases that include valuable nanodiamond by tightly controlling the flash Joule heating process they developed 18 months ago.
Best of all, they can stop the process at will to get product they want.
In the American Chemical Society journal ACS Nano, the researchers led by Tour and graduate student and lead author Weiyin Chen show that adding organic fluorine compounds and ...
2021-06-21
LAWRENCE -- Tulsa may not be the first town one thinks of when talking about jazz, and flood management may not be the first vocation one compares to the musical genre. But the success Tulsa displayed in going from one of the nation's most flood-prone cities to a nationally recognized model of long-term risk reduction in just two decades is analogous to the evolution of one of the most American styles of music, a University of Kansas professor points out in a new study.
Tulsa, the second-largest city in Oklahoma, suffered several devastating floods in the 1970s and 1980s, then became a national model for flood mitigation by the 1990s. What hasn't been studied closely is how a group of engineers, planners, government officials, journalists, attorneys and citizens came together ...
2021-06-21
The word "tsunami" brings immediately to mind the havoc that can be wrought by these uniquely powerful waves. The tsunamis we hear about most often are caused by undersea earthquakes, and the waves they generate can travel at speeds of up to 250 miles per hour and reach tens of meters high when they make landfall and break. They can cause massive flooding and rapid widespread devastation in coastal areas, as happened in Southeast Asia in 2004 and in Japan in 2011.
But significant tsunamis can be caused by other events as well. The partial collapse of the volcano Anak Krakatau in Indonesia in 2018 caused a tsunami that killed more than 400 people. Large landslides, which send immense amounts of debris into the sea, also ...
2021-06-21
Following fertilization, early plant embryos arise through a rapid initial diversification of their component cell types. As a result, this series of coordinated cell divisions rapidly sculpts the embryo's body plan. The developmental phenomenon in question is orchestrated by a transcriptional activation of the plant genome. However, the underlying cellular differentiation programs have long remained obscured as the plant embryos were hard to isolate. In fact, previous attempts at creating datasets of the plant embryonic differentiation programs were incapable ...
2021-06-21
A commonly studied perovskite can superfluoresce at temperatures that are practical to achieve and at timescales long enough to make it potentially useful in quantum computing applications. The finding from North Carolina State University researchers also indicates that superfluorescence may be a common characteristic for this entire class of materials.
Superfluorescence is an example of quantum phase transition - when individual atoms within a material all move through the same phases in tandem, becoming a synchronized unit.
For example, when atoms in an optical material such as a perovskite are excited they can individually radiate light, create energy, and fluoresce. Each atom will start moving through these phases randomly, but given the right conditions, they can synchronize in ...
2021-06-21
All plant cells obtain their energy mainly from two organelles they contain - chloroplasts (responsible for photosynthesis) and mitochondria (responsible for the biochemical cycle of respiration that converts sugars into energy). However, a large number of a plant cell's genes in its mitochondria and chloroplasts can develop defects, jeopardising their function. Nevertheless, plant cells evolved an amazing tool called the RNA editosome (a large protein complex) to repair these kinds of errors. It can modify defective messenger RNA that result from defective DNA by transforming (deamination) of certain mRNA nucleotides.
Automatic error correction in plant cells
Automatic error correction in plants was discovered about 30 years ago by a team headed by plant physiologist Axel Brennicke ...
LAST 30 PRESS RELEASES:
[Press-News.org] Study shows registry data could support clinical trials
Baseline data elements from DAPT Study strongly agree with CathPCI Registry data
