Coronary Sinus Reducer in Patients With Angina With no Obstructive Coronary Disease
NCT07010029
ANOCA, Angina Pectoris
Warsaw, Poland
View Trial DetailsNCT Number: NCT07802457
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.
Trial opening soon.
Get Notified18 year and older
Female
Observational
Essex cardiothoracic centre, Basildon, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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.
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
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
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
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.
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.
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.
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.
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.
Time frame: Over 25 years
We will record how often the participants see their medical providers and for which reason
Contact information is provided by the study sponsor or research team.
Clare Dolan
CONTACT
PMU Mail box
CONTACT
NHS Greater Glasgow and Clyde
Other
Diagnosis of Women With ANOCA: a Registry-based Cohort Study
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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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