Coronary Disease Clinical Trial
— CorMicAOfficial title:
CORonary MICrovascular Angina (CorMicA): a Randomised, Controlled, Pilot Trial
Verified date | March 2020 |
Source | NHS National Waiting Times Centre Board |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Angina is form of chest pain that is due to a lack of blood to the heart muscle. Angina is commonly triggered by stress and exertion, and is a common health problem worldwide. The diagnosis and treatment of angina is usually focused on detection of blockages in heart arteries, and relief of this problem with drugs, stents or bypass surgery. However, about one third of all invasive angiograms that are performed in patients with angina do not reveal any blockages. Many of such patients may have symptoms due to narrowings in the very small micro vessels (too small to be seen on an angiogram). The purpose of this research is to undertake a 'proof-of-concept' clinical trial to gather information as to whether routine tests of small vessel function in the heart might help identify patients with a stable coronary syndrome due to a disorder of coronary function (vasospastic or microvascular angina), and appropriately rule out this problem in patients with normal test results. The diagnostic strategy enables stratification of patient sub-groups to optimized therapy (personalised medicine). Evidence of patient benefits in this study would support the plan for a larger study that would be designed to impact on healthcare costs and patient reported outcome measures (PROMS).
Status | Completed |
Enrollment | 151 |
Est. completion date | November 6, 2019 |
Est. primary completion date | July 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: A clinically-indicated plan for invasive coronary angiography. Symptoms of angina or angina-equivalent (according to the Rose- and Seattle Angina questionnaires). Exclusion Criteria: A non-coronary indication for invasive angiography e.g. valve disease During the angiogram: obstructive disease evident in a main coronary artery (diameter >2.5 mm), i.e. a coronary stenosis>50% or a fractional flow reserve (FFR) =0.80 Lack of informed consent. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Golden Jubilee National Hospital | Clydebank | Dunbartonshire |
United Kingdom | Hairmyres Hospital | East Kilbride | Lanarkshire |
Lead Sponsor | Collaborator |
---|---|
NHS National Waiting Times Centre Board | British Heart Foundation |
United Kingdom,
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Ford TJ, Berry C. How to Diagnose and Manage Angina Without Obstructive Coronary Artery Disease: Lessons from the British Heart Foundation CorMicA Trial. Interv Cardiol. 2019 May 21;14(2):76-82. doi: 10.15420/icr.2019.04.R1. eCollection 2019 May. Review. — View Citation
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* Note: There are 26 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Health status (Seattle Angina Score) | Health status and symptoms will be assessed at baseline and again at 6 months using the Seattle Angina Questionnaire. The primary outcome is the within-subject change in SAQ score at 6 months from baseline. | 6 months | |
Secondary | Feasibility of the stratified medicine approach defined by protocol compliance as measured by deviations from the protocol. | Feasibility will be assessed in terms of enrolment rates and protocol compliance relating to enrolment, cross-over, integrity of blinding, adherence with therapy during follow-up, and compliance with follow up assessments | Through study completion, 3 years | |
Secondary | Procedure-related serious adverse events | Safety as reflected by the occurrence of procedure-related serious adverse events | Day 1 (index coronary angiogram procedure) | |
Secondary | Prevalence of endotypes | Diagnosis of endotypes (disease strata): obstructive CAD, coronary vasospastic angina, microvascular angina, endothelial dysfunction (no angina), normal (non-cardiac, normal coronary function results, no angina). | Day 1 | |
Secondary | Diagnostic utility of the diagnostic intervention | Impact of disclosure of the coronary function test results on the diagnosis and certainty of the diagnosis (diagnostic utility) | Day 1 | |
Secondary | Clinical utility of the stratified approach | Impact of disclosure of the coronary function test results on medical decisions (including treatment and investigations), and to compare these decisions against a medical decisions formed by an independent panel of experts (reference dataset) | Day 1 | |
Secondary | Cardiovascular risk factors | Assess the relationships between cardiovascular risk factors, reflected by validated risk scores (e.g. ASSIGN, JBS3), and parameters of coronary function, in medically managed patients. | Day 1 | |
Secondary | Anxiety and depression | Assess the participants' self-reported levels of anxiety and depression using the Patient Health Questionnaire-4 (PHQ-4) | Through study completion, 3 years | |
Secondary | Treatment satisfaction | Assess the participants' self-reported levels of treatment satisfaction using the Treatment Satisfaction Questionnaire for Medication (TSQM) | Through study completion, 3 years | |
Secondary | Illness perception | Assess the participants' perception of their illness using the brief Illness Perception Questionnaire | Through study completion, 3 years | |
Secondary | Health status EQ5D | Assess the participants' general health status and self reported quality of life using the EQ5D questionnaire. | Through study completion, 3 years | |
Secondary | Health status (Seattle Angina Score) | Health status and symptoms will be assessed at baseline and again at 6 months, 12 months and close-out using the Seattle Angina Questionnaire. The secondary outcome is the within-subject change in SAQ score over time. | Through study completion, 3 years | |
Secondary | Biomarkers | Assess associations between circulating molecules that are implicated in the pathophysiology of disorders of coronary function. | 36 months | |
Secondary | Health economics | Assess resource utilisation including primary and secondary care costs for tests, procedures and out-patient visits, and medicines, between the randomised groups | 36 months | |
Secondary | Myocardial perfusion | Assess the diagnostic accuracy of stress perfusion magnetic resonance imaging for identification of endotypes based on reference tests of coronary function. | 42 days | |
Secondary | Incidental findings | Detection of clinically significant (actionable) incidental findings using magnetic resonance imaging. The incidental findings may be cardiac or non-cardiac. | 42 days | |
Secondary | Myocardial tissue characterisation | Detection of myocardial pathology using multiparametric CMR | 42 days |
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