Angina With No Obstructive Coronary Artery DiseaseNCT07802457
Diagnosis of Women With ANOCA
An observational study of Angina With No Obstructive Coronary Artery Disease, run by NHS Greater Glasgow and Clyde at 11 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Angina With No Obstructive Coronary Artery Disease
- How many people
- 400 participants
- Where
- 11 sitesUnited Kingdom
- Study dates
- 27 Nov 2026to 30 Jun 2029
- How long will I take part?
- 25 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include women of biological female sex with ANOCA and the participants should have a diagnosis of microvascular angina and/or vasospastic angina and an endotype defined by recent diagnostic tests within one year of enrolment.
Who may be able to join
- ANOCA endotype0
- Myocardial perfusion reserve or coronary flow reserve recorded within one year
- Seattle Angina Questionnaire frequency score <100
- Female sex
Who cannot join
- Age <18 years
- Unable to provide informed consent
- Unable to comply with the protocol
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United Kingdom11 sites
Essex cardiothoracic centre
Basildon
Royal United Hospital Bath
Bath
Royal Papworth Hospital
Cambridge
Queen Elizabeth University Hospital Clinical Research Facility,
Glasgow, G51 4TF
Colin Berry, 0141 232 7600, Colin.Berry@glasgow.ac.uk
Leeds General Infirmary
Leeds
Brompton Hospital
London
Guys and St Thomas Hospital
London
Kings college london
London
Freeman Hospital
Newcastle upon Tyne
Nottingham City Hospital
Nottingham
Sunderland Royal Hospital
Sunderland
About this study
Official title: Diagnosis of Women With ANOCA: a Registry-based Cohort Study
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.
Read more
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.
Read the 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.
- Keywords
- Angina, Cardiovascular disease, Cohort study, Endotype, Women
- Medical subject headings
- Angina Pectoris, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Women with ANOCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seattle Angina Questionnaire
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
Measured: Enrolment
Secondary outcomes (11)
Brief Illness perception Questionnaire (Brief IPQ)
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
Measured: Enrolment
Patient Health Questionnaire-4 of (PHQ4)
An ultra-brief screening tool used to assess core symptoms of anxiety and depression. Higher scores indicate greater feelings of anxiety and depression.
Measured: Enrolment
Duke Activity Status Index (DASI)
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
Measured: Enrolment
EQ-5D (EQ-5D-5L)
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
Measured: Enrolment
Treatment Satisfaction Questionnaire for Medication (TSQM)
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
Measured: Enrolment
The Montreal Cognitive Assessment (MoCA)
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.
Measured: Enrolment
Sex specific cardiovascular risk score - Heart age score
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.
Measured: Across 25 years
Sex specific cardiovascular risk score - QRisk score
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.
Measured: Across 25 years
Sex specific cardiovascular risk score - EuroSCORE II
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.
Measured: Across 25 years
Dementia risk score
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.
Measured: Baseline
Episodes of care
We will record how often the participants see their medical providers and for which reason
Measured: Over 25 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start27 Nov 2026 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina With No Obstructive Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 25 Years
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Colin Berry, PhD, Principal investigator, The University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802457
- Sponsor's protocol ID
- GN26CA078
- Other IDs
- 375950
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A decision will be made by the TSC once the study has ended.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Women With ANOCA: a Registry-based Cohort Study
- ClinicalTrials.gov ID
- NCT07802457
- Acronym / sponsor ID
- GN26CA078
- Keywords
- Angina, Cardiovascular disease, Cohort study, Endotype, Women
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- The University of Glasgow
- Study start
- 27 Nov 2026 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 25 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Women with ANOCA |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include women of biological female sex with ANOCA and the participants should have a diagnosis of microvascular angina and/or vasospastic angina and an endotype defined by recent diagnostic tests within one year of enrolment.
Key inclusion criteria (4 listed)
- ANOCA endotype0
- Myocardial perfusion reserve or coronary flow reserve recorded within one year
- Seattle Angina Questionnaire frequency score <100
- Female sex
Key exclusion criteria (3 listed)
- Age <18 years
- Unable to provide informed consent
- Unable to comply with the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
11 secondary outcomes
Brief Illness perception Questionnaire (Brief IPQ)
Time frame: Enrolment
Patient Health Questionnaire-4 of (PHQ4)
Time frame: Enrolment
Duke Activity Status Index (DASI)
Time frame: Enrolment
EQ-5D (EQ-5D-5L)
Time frame: Enrolment
Treatment Satisfaction Questionnaire for Medication (TSQM)
Time frame: Enrolment
The Montreal Cognitive Assessment (MoCA)
Time frame: Enrolment
Sex specific cardiovascular risk score - Heart age score
Time frame: Across 25 years
Sex specific cardiovascular risk score - QRisk score
Time frame: Across 25 years
Sex specific cardiovascular risk score - EuroSCORE II
Time frame: Across 25 years
Dementia risk score
Time frame: Baseline
Episodes of care
Time frame: Over 25 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: Yes. A decision will be made by the TSC once the study has ended.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Colin Berry, PhD principal investigator
The University of Glasgow
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angina With No Obstructive Coronary Artery Disease, run by NHS Greater Glasgow and Clyde at 11 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clare Dolan (0141 314 4328, clare.dolan3@nhs.scot), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seattle Angina Questionnaire (time frame: Enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.