No registrations found.
ID
Source
Brief title
Health condition
Anomalous coronary artery from the opposite sinus
Right or left coronary artery from the pulmonary artery
Coronary arteriovenous fistulas
Sponsors and support
Intervention
Outcome measures
Primary outcome
-(cardiac) death
-Myocardial ischemia attributable to the ACAOS
-Re-intervention after surgery
-Intervention after initially conservative treatment
Secondary outcome
-Quality of life based on the SF-36 questionnaire
-Thoracic complaints (typical, atypical, non-anginal)
-Heart failure demanding medical treatment
Background summary
Evidence for the treatment of patients with coronary anomalies is scarce and treatment decisions are thus very heterogeneous, especially for patients with an anomalous coronary artery from the opposite sinus (ACAOS) with an interarterial course, that are potentially prone to sudden cardiac death. In this study, prospectively included patients with an ACAOS receive work-up according to a structured protocol using CT-angiography, ischemia detection testing, echocardiography and coronary angiography with intracoronary measurements to assess anatomical and physiological characteristics of the ACAOS. During follow-up, surgical and functional results are evaluated by CT-angiography, ischemia detection testing and a quality-of-life-questionnaire. Evaluated are (cardiac) death, myocardial ischemia attributable to the ACAOS, re-intervention after surgery and intervention after initially conservative treatment, and the influence of work-up examinations on treatment choice. Patients are followed-up for at least 2 years.
Registry is done for patients with right or left coronary artery from the pulmonary artery and coronary arteriovenous fistulas.
The aim is to provide evidence substantiated recommendations for diagnostic work-up, treatment and follow-up of patients with anomalous coronary arteries.
Study objective
N.A.
Study design
September 2020 start enrollment
December 2023 end enrollment
2026 end of follow-up last included patient
Intervention
-Coronary CT angiography, using 0.5-1mm slices (work-up and follow-up after surgery)
-Transthoracic echocardiography (work-up)
-CAG with IVUS and FFR measurement (and iFR or CFR) of the interarterial and septal ACAOS using adrenalin and adenosine or dobutamin (work-up)
-Ischemia detection test (work-up and follow-up after surgery)
Every participating hospital will perform the tests according to the physicians insights and possibilities of the hospital. Preferably all examinations are done as standard of care, because each test examines a different fysiological aspect.
Inclusion criteria
Patients with the diagnosis of:
-ACAOS
-Coronary artery from the pulmonary artery
-Coronary arteriovenous fistula
Exclusion criteria
-History of (hemodynamically significant) congenital heart defects other than the coronary anomaly
-ACAOS patients with proven coronary atherosclerotic disease with significant stenosis (after treatment of the stenosis, patients with can be ACAOS are reconsidered for inclusion)
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8777 |
| CCMO | NL69310.058.19 |
| OMON | NL-OMON55795 |