Angina With No Obstructive Coronary Artery Disease
Conditions
Keywords
Angina, Cardiovascular disease, Cohort study, Endotype, Women
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
NHS Greater Glasgow and Clyde
The University of Glasgow
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ANOCA endotype0 * Myocardial perfusion reserve or coronary flow reserve recorded within one year * Seattle Angina Questionnaire frequency score \<100 * Female sex
Exclusion criteria
* Age \<18 years * Unable to provide informed consent * Unable to comply with the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seattle Angina Questionnaire | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brief Illness perception Questionnaire (Brief IPQ) | Enrolment | A nine-item scale designed to rapidly assess the cognitive and emotional representations of illness. It consists of 9 items: 8 are scored on a 0-10 scale, and item 9 is an open-ended question assessing perceived causes. The total score (0-80) is calculated by summing the first 8 items, with items 3, 4, and 7 reverse scored. Higher scores generally reflect a more threatening perception of the illness |
| Patient Health Questionnaire-4 of (PHQ4) | Enrolment | An ultra-brief screening tool used to assess core symptoms of anxiety and depression. Higher scores indicate greater feelings of anxiety and depression. |
| Duke Activity Status Index (DASI) | Enrolment | A 12-item, self-administered questionnaire used to estimate a patient's functional capacity and peak oxygen uptake. Scores range from 0 to 58.2, with higher scores indicating better physical fitness and lower risk |
| EQ-5D (EQ-5D-5L) | Enrolment | The EQ-5D evaluates health across 5 domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). It yields three metrics: a 5-digit health profile string, a weighted index value, and a 0-100 self-rated Visual Analogue Scale (VAS) score. For the 5-digit health profile string higher individual numbers indicate worse health problems. For the weighted index value a score of 1 indicates perfect health, while 0 represents death. For the visual analogue score higher numbers here indicate better health |
| Treatment Satisfaction Questionnaire for Medication (TSQM) | Enrolment | Measures patient satisfaction with their prescription medications. It evaluates core aspects of a patient's treatment experience, including effectiveness, side effects, convenience, and overall satisfaction. Individual item scores within each domain are summed and transformed into a standardized scale from 0 to 100, where higher scores mean greater treatment satisfaction |
| The Montreal Cognitive Assessment (MoCA) | Enrolment | 30-point medical screening test used by health professionals to detect early signs of mild cognitive impairment and dementia. It covers domains such as memory, visuospatial awareness, executive function, attention, language and orientation to place and time. Higher scores indicate better cognitive function with scores 30-26 indicating normal function, 25-18 indicating mild cognitive impairment and below 18 indicating potential thinking and memory problems. |
| Sex specific cardiovascular risk score - Heart age score | Across 25 years | Heart age score can indicate chance of having a heart attack, stroke or developing heart disease. It uses height, weight, blood pressure, cholesterol levels and family history of disease to calculate a heart age. If the age of participant's heart is older than their actual age, they are at higher risk for developing a heart condition. The investigators want to understand if women have sex specific risks. |
| Sex specific cardiovascular risk score - QRisk score | Across 25 years | QRISK is a calculation to estimate participants' risk of developing cardiovascular disease over the next 10 years. It uses information such as age, sex, ethnic background, where participants live, smoking status, weight, existing medical conditions, family history and blood pressure to calculate a score. A score of less than 10% indicates low risk, 10-20% indicates moderate risk and 20% or higher indicates higher risk of developing heart disease over the next 10 years. The investigators want to understand if women have sex specific risks. |
| Sex specific cardiovascular risk score - EuroSCORE II | Across 25 years | EuroSCORE II a risk assessment tool that estimates the percentage risk of dying during or shortly after major heart surgery. It uses patient related factors such as age, gender, presence of chronic kidney disease, diabetes and poor mobility. Cardiac related factors such as presence of recent heart attack, how well the heart pumps blood and pulmonary hypertension (high blood pressure in the arteries that carry blood from your heart to your lungs), and operation related factors such as how urgent the procedure is. The final score is expressed as a percentage representing the predicted probability of dying in hospital. Scores under 2% represent low predicted risk, Scores between 2% and 5% reflect a moderate risk level and scores of 6% or higher place a patient in a higher-risk category, where the complexity or underlying conditions significantly elevate risk. The investigators want to understand if women have sex specific risks. |
| Dementia risk score | Baseline | We will use UK Biobank Dementia Risk Score (UKBDRS) to understand participant's risk of dementia. Items such as age, education, smoking history and medication use are considered to give a score. Higher scores describes a higher probability of dementia within the next 14 years but is not a clinical diagnosis. |
| Episodes of care | Over 25 years | We will record how often the participants see their medical providers and for which reason |
Countries
United Kingdom
Contacts
CONTACTClare Dolan
CONTACTPMU Mail box
PRINCIPAL_INVESTIGATORColin Berry, PhD
The University of Glasgow
Outcome results
None listed