Trial status
MAY, RECRUITMENT, RECRUITMENT
Recruitment began in September 2019 and has been completed on 11 May 2023. The trial opened using protocol v2.0, and the current protocol in use is v5.0.Key amendments for the TARGET CTCA trial include:Amendment (September 7, 2020): Addition of new sites.Protocol Amendment v3.0 (March 25, 2021): Changes to data collection methods at sites, clarifications to Sect. 5.1 (identifying participants), Sect. 5.4 (withdrawals), Sect. 6.1.2 (scanning visit), Sect. 6.1.3 (management recommendations), Sect. 7 (assessments), and Sect. 8.2 (proposed analyses, introduction of COVID-19 test data).Amendment (August 4, 2021): Recruitment extension from September 1, 2021, to August 31, 2022, due to impact of COVID-19.Protocol Amendment v4.0 (July 7, 2022): Recruitment extension for 8 months until April 2023 and an increase in the recruitment target from 2270 to 3170.Protocol Amendment v5.0 (September 26, 2022): Introduction of a new lifestyle questionnaire at 24 months.