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Coronary and Peripheral Haemodynamic Studies of Angina with Normal Coronary Arteries

Clinical and coronary haemodynamic determinants of recurrent chest pain in patients without obstructive coronary artery disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12617001483347
Acronym
COMBO STUDY
Enrollment
57
Registered
2017-10-19
Start date
2013-10-08
Completion date
Unknown
Last updated
2021-06-07

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 disease on coronary angiogram (NoCAD). Despite no significant obstructive CAD most of these patients continue to experience recurrent chest pain without any definitive diagnosis. Main aim of this study is to investigate patients with angina and NoCAD with a comprehensive invasive coronary and peripheral haemodynamic studies at the time of diagnostic coronary angiogram and to evaluate the prevalence of various vasomotor disorders in these patients. Further we aim to relate the results of testing to outcome by determining the clinical and coronary haemodynamic predictors of recurrent chest pain on one and 12 months follow up.

Interventions

Patients with angina and no obstructive coronary disease on angiogram will undergo comprehensive invasive coronary haemodynamic studies at the time of diagnostic coronary angiogram to evaluate possible coronary disorder leading to patient's symptoms and then relating the testing results to outcome, which in this study is ongoing chest pain at one and 12 months follow up. Haemodynaamic studies will include the assessment of resting angiographic contrast flow, coronary microvascular hyperaemic fu

Patients with angina and no obstructive coronary disease on angiogram will undergo comprehensive invasive coronary haemodynamic studies at the time of diagnostic coronary angiogram to evaluate possible coronary disorder leading to patient's symptoms and then relating the testing results to outcome, which in this study is ongoing chest pain at one and 12 months follow up. Haemodynaamic 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 angiogram procedure.

Sponsors

University of Adelaide
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Patients with (1) clinical diagnosis of angina, (2) persistent angina and (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%), or (4) alternative coronary explanations for the chest pain - obstructive CAD (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, or (5) other cardiovascular disorders - pulmonary hypertension, pulmonary embolism, hypertrophic cardiomyopathy, or valvular heart disease.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026