Diagnosis of Women With ANOCA

NCT07802457 | Not Yet Recruiting

• 2 other identifiers: GN26CA078375950
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 11

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.

Conditions

Angina With No Obstructive Coronary Artery Disease

Keywords

Angina; Cardiovascular disease; Cohort study; Endotype; Women

Outcome Measures

Primary Outcomes (1)

• 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

  Enrolment

Secondary Outcomes (11)

• 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

Study Arms (1)

Cohort 1

Women with ANOCA

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• ANOCA endotype0
• Myocardial perfusion reserve or coronary flow reserve recorded within one year
• Seattle Angina Questionnaire frequency score \<100
• Female sex

You may not qualify if:

• Age \<18 years
• Unable to provide informed consent
• Unable to comply with the protocol

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• The University of Glasgow: collaborator

Study Sites (11)

Essex cardiothoracic centre

Basildon, United Kingdom

Location

Royal United Hospital Bath

Bath, United Kingdom

Location

Royal Papworth Hospital

Cambridge, United Kingdom

Location

Queen Elizabeth University Hospital Clinical Research Facility,

Glasgow, G51 4TF, United Kingdom

Location

Leeds General Infirmary

Leeds, United Kingdom

Location

Brompton Hospital

London, United Kingdom

Location

Guys and St Thomas Hospital

London, United Kingdom

Location

Kings college london

London, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, United Kingdom

Location

Nottingham City Hospital

Nottingham, United Kingdom

Location

Sunderland Royal Hospital

Sunderland, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, plasma, buffy coat

MeSH Terms

Conditions

Angina Pectoris; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Colin Berry, PhD

  The University of Glasgow

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clare Dolan

CONTACT

0141 314 4328; clare.dolan3@nhs.scot

PMU Mail box

CONTACT

0141 314 4328; ggc.pmu.research@nhs.scot

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 25 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: September 3, 2026
• Study Start (Estimated): November 27, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: September 3, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After the study has completed
• Access Criteria: Bone fide collaboration request

Locations

GB (11)