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NCT Number: NCT07802457

Diagnosis of Women With ANOCA

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Essex cardiothoracic centre, Basildon, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Seattle Angina Questionnaire

    Time frame: 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 outcomes

  1. Brief Illness perception Questionnaire (Brief IPQ)

    Time frame: 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

  2. Patient Health Questionnaire-4 of (PHQ4)

    Time frame: Enrolment

    An ultra-brief screening tool used to assess core symptoms of anxiety and depression. Higher scores indicate greater feelings of anxiety and depression.

  3. Duke Activity Status Index (DASI)

    Time frame: 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

  4. EQ-5D (EQ-5D-5L)

    Time frame: 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

  5. Treatment Satisfaction Questionnaire for Medication (TSQM)

    Time frame: 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

  6. The Montreal Cognitive Assessment (MoCA)

    Time frame: 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.

  7. Sex specific cardiovascular risk score - Heart age score

    Time frame: 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.

  8. Sex specific cardiovascular risk score - QRisk score

    Time frame: 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.

  9. Sex specific cardiovascular risk score - EuroSCORE II

    Time frame: 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.

  10. Dementia risk score

    Time frame: 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.

  11. Episodes of care

    Time frame: Over 25 years

    We will record how often the participants see their medical providers and for which reason

Study contacts

Contact information is provided by the study sponsor or research team.

Clare Dolan

CONTACT

[email protected]

0141 314 4328

PMU Mail box

CONTACT

[email protected]

0141 314 4328

Sponsors and collaborators

Lead sponsor

NHS Greater Glasgow and Clyde

Other

Collaborators

  • The University of Glasgow

Registry information

Official study title

Diagnosis of Women With ANOCA: a Registry-based Cohort Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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