ArticleJMIR formative research2022
Characteristics and Outcomes of Clinical Trials on Gene Therapy in Noncongenital Cardiovascular Diseases: Cross-sectional Study of Three Clinical Trial Registries.
Article in JMIR formative research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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0 citing papers in PubMed, 1 citations in OpenAlex.
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Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCardiovascular diseases remain the leading cause of morbidity and mortality worldwide. Gene therapies (GTs) may become a novel therapeutic option for cardiovascular diseases.
objectiveWe aimed to characterize all trials involving human subjects utilizing GT to treat noncongenital cardiovascular diseases.
methodsIn March 2021, we searched for clinical trials on the ClinicalTrials.gov (CT), International Clinical Trials Registry Platform (ICTRP), and International Standard Randomised Controlled Trials Number (ISRCTN) databases. Two authors screened the titles and registry notes of all the searched studies. We collected details of the included studies regarding their design, location funding source, treated conditions, completion, publication statuses, and final outcomes.
resultsWe generated a total of 3508 records, and 50 unique clinical trials met our eligibility criteria. Of these, 20 (40%) concerned peripheral artery disease, and 18 (36%) concerned coronary artery disease. Most studies were randomized (34/50, 68%) and were performed in multiple locations (30/50, 60%), and around half of the trials compared GT with a placebo (27/50, 54%), while one in four were single-arm (14/50, 28%), and the rest concerned dose-finding (22%). More than half of the trials (29/50, 58%) were funded by industry. Of the 50 clinical trials, 28 (56%) published their results by the data collection date (March 2021), and 22 of 31 (71%) were slated to be completed before 2021. Overall, 12 of 28 (42.9%) clinical trials showed favorable outcomes of the intervention.
conclusionsAmong noncongenital cardiovascular diseases, GTs are mostly investigated in peripheral artery disease and coronary artery disease. Many clinical trials on GT use in noncongenital cardiovascular diseases did not disclose their results. Regardless of the trial phase, less than half of published studies on GT in noncongenital cardiovascular diseases showed promising results.
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