Health TrialsbyHealthPanel

Diagnosis of Women With ANOCA

ConditionAngina With No Obstructive Coronary Artery Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorNHS Greater Glasgow and Clyde

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ANOCA endotype0

Myocardial perfusion reserve or coronary flow reserve recorded within one year

Seattle Angina Questionnaire frequency score <100

Female sex

Disqualifiers

Age <18 years

Unable to provide informed consent

Unable to comply with the protocol

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

400 Participants
are grouped into 1 trial group
Group A: Cohort 1

Trial outcomes

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

Time frame
Enrolment

Secondary outcomes

1

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

Time frame
Enrolment
2

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.

Time frame
Enrolment
3

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

Time frame
Enrolment
4

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

Time frame
Enrolment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NHS Greater Glasgow and Clyde

Lead sponsor

The University of Glasgow

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: