coronary vasomotor dysfunction microcirculatory dysfunction
Conditions
Interventions
The left anterior descending (LAD) coronary artery will in general be the
target coronary artery for
measurement of microvascular function. The cardiologists may decide to select
the
diagonal/inte
Sponsors
Glasgow University
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years. 2. A clinical plan for invasive coronary angiography. 3. Symptoms of angina (typical or atypical) according to the Rose- and/or Seattle Angina questionnaires. 4. Able to comply with study procedures. 5. Able to provide informed consent.
Exclusion criteria
Exclusion criteria: 1. A non-coronary primary indication for invasive angiography (e.g. valve disease, heart failure). 2. History of coronary artery bypass surgery. 3. Presence of obstructive disease evident in a main coronary artery (diameter >2.5 mm), i.e. a coronary stenosis >50% and/or a fractional flow reserve (FFR) <=0.80.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy variable will be the SAQ Summary Score at 12 months, which will be compared between the groups using a linear regression model, adjusting for the baseline score. | — |
Secondary
| Measure | Time frame |
|---|---|
| 8.3 Secondary outcomes (detailed) 8.3.1 Feasibility and process * Rates of enrolment, drop-out, completion of the diagnostic protocol, * Integrity of blinding in the catheter laboratory and blinding at 1 year (patient and attending clinician) * Loss to follow-up including time-point 8.3.2 Safety Safety of coronary function tests, as reflected by SAEs related to the procedure in a multicentre setting, and those arising during longer term follow-up. 8.3.3 Diagnostic utility To assess impact of disclosure of the coronary function test results on the diagnosis and the certainty of the diagnosis (diagnostic utility) in a multicentre setting (Appendix 4), The clinician*s diagnosis i.e. coronary heart disease, angina due to obstructive coronary heart disease, angina due to a disorder of coronary function e.g. microvascular angina, vasospastic angina, will be assessed for certainty (yes/no vs unlikely/probable in the primary analysis) and frequency (yes/probable vs unlikely/no). A missed diagnosis of microvascular angina and/or vasospastic angina was defined as the final physician diagnosis of non-cardiac chest pain in the presence of objective abnormalities of coronary artery function. 8.3.4 Clinical utility To assess impact of disclosure of the coronary function test results on clinical management (including treatment and investigations) (Appendix 2), Comparison of health status: Rose Angina, Seattle Angina scores (5 components and summary score), EQ5D health status, Illness perception, Treatment Satisfaction, Diet Questionnaire, Duke Activity Status Index, International Physical Activity Questionnaire short-form. Assess changes to medications, and long-term compliance with medications, as measures of the clinical utility of the overall strategy. To assess the relationships between baseline cardiovascular risk factors and parameters of coronary function in medically managed patients. Healthcare resource utilisation including prim | — |
Countries
Ireland, Netherlands, Poland, United Kingdom
Contacts
Public ContactP Damman
Radboud Universitair Medisch Centrum
Outcome results
None listed