niversity Medical Centre Utrecht - National collaborative knowledge platform to impact on sex- and gender sensitive cardiovascular medicine - pilot

Recruiting

Conditions: coronary vasculary dysfunction
functional impairment of the small vessels of the heart and/or temporary spasm of vessels of the heart
10011082

Registration Number: NL-OMON51881

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

- Patients referred for a coronary function test because of chronic angina,
defined as symptoms of angina at least 2 times a month despite medical therapy
for the last 3 months, in whom obstructive coronary artery disease was ruled
out by coronary computed tomography angiography or coronary angiography.
- Patient is willing and able to provide written informed consent for
participation in this study
- Patient is willing and able to provide written informed consent for blood
withdrawal and storage of blood in the biobank

Exclusion Criteria

- Insufficient understanding and communication Dutch language.
- No consent of the patient to participate in the study.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint of this study is to find out if and which (dynamic) ECG<br /><br>changes can be detected in patients with angina and non-obstructive coronary<br /><br>arteries, by measuring the ECG at home for several days, and how the ECG<br /><br>changes can be detected, by body surface potentials measurement at the hospital<br /><br>before and after exercise. The results of this study will be used to set-up a<br /><br>diagnostic study to investigate if ECG home monitoring has added value in the<br /><br>diagnosis of microvascular angina / vasospastic angina. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Baseline study parameters including (but not limited to) age, gender,<br />ethnicity, medical history, risk factors and symptoms will be collected and<br />investigated. In addition, with the patient*s consent, clinical care data is<br />collected from the referring centres and information on morbidity and mortality<br />is collected, by means of linkage with national registries.</p>