Diagnosis of Women With ANOCA: a Registry-based Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 11
- 主要终点
- Seattle Angina Questionnaire
研究概览
简要总结
Angina is a feeling of chest pain or discomfort which can happen if there is reduced blood flow to the heart. Patients can experience angina with no obstructive coronary arteries (ANOCA) which is a difficult condition to treat (ie relieve angina) since few randomised, controlled therapy trials have been undertaken for ANOCA.
Until now, angina has been mainly studied in men even though women are at least two-fold more likely than men to experience ANOCA.
Research studies involving people with ANOCA may have limitations in relation to retrospective collection of historical data or lack of prospectively collected contemporary data. These limitations are particularly relevant to women with ANOCA which is an area that has been historically under-recognised.
Prior studies may have data gaps, such as for women's health. For these reasons, the Investigators propose a research registry for women with ANOCA which aims to plug these gaps. The Investigators aim to understand the biological mechanisms behind angina in women specifically.
This study will categorise ANOCA into different subtypes and offer women the opportunity to take part in research studies to treat ANOCA. The Investigators will also follow the women's health over time through remote data collection methods.
详细描述
There is a paucity of evidence of long term outcomes of women with ANOCA or understanding of the potentially unique mechanisms which could drive ANOCA in women specifically.
In order to understand the impact of ANOCA, and related endotypes, on an individual's wellbeing and the related healthcare needs, follow-up for vital status, episodes of care (primary and secondary care) and medication use is vital.
The availability of electronic health records in the NHS is enabling for this purpose and without the need to contact patients. Accordingly, in ANOCA Diagnosis, women will be followed up without requiring further visits post enrolment.
Furthermore, allowing endotyping of the ANOCA allows for targeted treatments. Women in this trial will be approached for participation in future research studies for potential new treatments for ANOCA.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ANOCA endotype0
- •Myocardial perfusion reserve or coronary flow reserve recorded within one year
- •Seattle Angina Questionnaire frequency score <100
- •Female sex
排除标准
- •Age <18 years
- •Unable to provide informed consent
- •Unable to comply with the protocol
研究组 & 干预措施
Cohort 1
Women with ANOCA
结局指标
主要结局
Seattle Angina Questionnaire
时间窗: Enrolment
The Seattle Angina Questionnaire a validated 19-item patient-reported survey used to measure coronary artery disease and angina treatment efficacy. Patients will complete on paper or electronically. The scores range from 0 to 100, with higher scores indicating less frequent angina, improved function, and better quality of life
次要结局
- Brief Illness perception Questionnaire (Brief IPQ)(Enrolment)
- Patient Health Questionnaire-4 of (PHQ4)(Enrolment)
- Duke Activity Status Index (DASI)(Enrolment)
- EQ-5D (EQ-5D-5L)(Enrolment)
- Treatment Satisfaction Questionnaire for Medication (TSQM)(Enrolment)
- The Montreal Cognitive Assessment (MoCA)(Enrolment)
- Sex specific cardiovascular risk score - Heart age score(Across 25 years)
- Sex specific cardiovascular risk score - QRisk score(Across 25 years)
- Sex specific cardiovascular risk score - EuroSCORE II(Across 25 years)
- Dementia risk score(Baseline)
- Episodes of care(Over 25 years)