Coronary and Peripheral Haemodynamic Studies of Angina with No Obstructive Coronary Artery Disease - association between invasive and non-invasive investigation modalities.

Coronary and Peripheral Haemodynamic Studies of Angina with No Obstructive Coronary Artery Disease.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12618000178246

Acronym

NoCAD2

Enrollment

Registered

2018-02-05

Start date

2018-02-01

Completion date

Unknown

Last updated

2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

About 20-30% of patients with angina have no obstructive coronary artery disease on coronary angiogram (NoCAD). Despite no significant obstructive coronary artery disease, most of these patients continue to experience recurrent chest pain without any definitive diagnosis. Comprehensive invasive coronary haemodynamic studies at the time of diagnostic coronary angiogram will provide important diagnostic and prognostic implications for the management of coronary vasomotor disorder, but routine assessment is difficult. The hyperaemic microvascular resistance (HMR) is a reliable but invasive measure to assess coronary microvascular function. The planned project will evaluate whether left ventricular contractile reserve (CR), measured with strain imaging on low dose dobutamine stress echocardiography (DSE), is a reliable non-invasive measure of coronary microvascular function.

Interventions

Patients with angina and no obstructive coronary artery disease on invasive diagnostic coronary angiography will undergo comprehensive invasive coronary haemodynamic studies at the time of procedure to evaluate possible coronary vasomotor disorder leading to patient's symptoms. Haemodynamic studies will include the assessment of resting angiographic contrast flow, coronary microvascular hyperaemic function, coronary endothelial function and provocative coronary spasm testing. This comprehensive testing will add 30-45 minutes to the diagnostic coronary angiography procedure. The invasive parameters will be analysed and correlate with non-invasive assessment of contractile reserve obtained from low dose dobutamine stress echocardiography technique, pulse waveform analysis parameters and retinal artery changes.

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Clinical diagnosis of angina 2. Persistent angina 3. Coronary angiography demonstrating normal or no obstructive coronary disease (<50% diameter stenosis)

Exclusion criteria

1. Admission for an acute coronary syndrome within the preceding month 2. Prior coronary artery bypass grafting 3. Contra-indications to coronary haemodynamic assessment - patients with permanent pacemaker or defibrillator, severe renal or hepatic insufficiency, severe asthma, left ventricular systolic dysfunction (ejection fraction <50%) 4. Alternative coronary explanations for the chest pain - obstructive coronary artery disease (flow limiting coronary stenosis i.e. derived fractional flow reserve (FFR) <0.80), spontaneous coronary spasm (but not catheter related spasm), spontaneous coronary artery dissection 5. Other cardiovascular disorders - pulmonary hypertension, pulmonary embolism, hypertrophic cardiomyopathy, or valvular heart disease.

Outcome results