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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON51881
Enrollment
50
Registered
2021-08-05
Start date
2021-11-01
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

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

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)