Loading
PET scan / Cardiovascular Diseases · Interventional Study
ClinicalTrials.gov · September 8, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registry record for a pilot feasibility study preparatory to the proposed HER CROWN prospective cohort study, which aims to develop a women-specific cardiovascular risk algorithm incorporating female-specific risk factors. No results are posted in this registry record; the pilot is active but no longer recruiting, and primary outcome measures are listed as planned assessments at 18 months.
Interventional, Non Randomized, Parallel, Open label, Other purpose. Cardiovascular Diseases; Female; age from 25 Years; to 55 Years; accepts healthy volunteers. Intervention: Sex-Specific Risk HDP Subgroup Factor Group and Age-Matched…. Compared with: Sex-Specific Risk factor group and Age-Matched Control Group — No Intervention. n = 176. 1 site: Canada.
This is a registry record for a pilot feasibility study preparatory to the proposed HER CROWN prospective cohort study, which aims to develop a women-specific cardiovascular risk algorithm incorporating female-specific risk factors. No results are posted in this registry record; the pilot is active but no longer recruiting, and primary outcome measures are listed as planned assessments at 18 months.
Hard cardiovascular outcomes (myocardial infarction, stroke, mortality) are stated as aims for the future full cohort, not measured in this pilot record.
This preliminary pilot study does not yet provide clinical evidence. Once completed and published, the HER CROWN cohort may establish a novel risk-stratification tool for women, but interim registry data carries no clinical recommendations.
This is a pilot feasibility study registration with no results posted; it describes planned enrollment and outcome measures for a future prospective cohort study, not a completed trial.
As stated by the source record.
Quoted from the source exactly as published.
This preliminary pilot study does not yet provide clinical evidence. Once completed and published, the HER CROWN cohort may establish a novel risk-stratification tool for women, but interim registry data carries no clinical recommendations.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05632601). This is a study registration, not published results. Lead sponsor: Ottawa Heart Institute Research Corporation. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 176 participants (ACTUAL). Conditions: Cardiovascular Diseases. Interventions: DIAGNOSTIC_TEST: PET scan. Primary outcome measures: Demographics questionnaire , 18 months; Medical History Questionnaire , 18 months; General Anxiety Disorder-7 (GAD-7) , 18 months; Patient Health Questionnaire (PHQ)-9 , 18 months; Perceived Stress Scale (PSS) , 18 months; The Index of Spouse Abuse (ISA) , 18 months; Childhood Trauma Questionnaire (CTQ) , 18 months; PTSD Checklist-5 (PCL-5) , 18 months; SF-12 , 18 months; Substance use questionnaire , 18 months; International Physical Activity Questionnaire (IPAQ) , 18 months; The Newest Vital Sign (NVS) , 18 months; Arterial tonometry , 18 months; Coronary CTA , 18 months; Cardiac PET , 18 months; Transthoracic echocardiography , 18 months; Blood work , 18 months; Satisfaction Questionnaire , 18 months. Brief summary: The full HER CROWN will be a prospective cohort study to propose a novel, women-specific cardiovascular risk score/ algorithm in the prediction of hard cardiovascular outcomes (myocardial infarction, unstable angina, coronary revascularization, stroke, total and cardiovascular mortality). This future study will be the first longitudinal cohort study, to our knowledge, that is focused entirely on researching the pathophysiology and natural history of cardiovascular disease in women with known female-specific risk factors. Further, the investigators are aiming to recruit a sample that is representative of the ethnic distribution in Canada. The proposed pilot study is a feasibility study as an essential preparatory step for HER CROWN.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.