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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03841383
Other study ID # CFRBH4_IT1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 6, 2017
Est. completion date July 10, 2019

Study information

Verified date July 2019
Source IRCCS San Raffaele
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To determine if there is a relationship between coronary flow reserve (CFR) and platelet/plasma BH2 and BH4 levels in patients with high cardiovascular risk .


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Echo stress dipyridamole
Echo stress dipyridamole

Locations

Country Name City State
Italy ASST Papa Giovanni XXIII Bergamo
Italy IRCCS Ospedale San Raffaele Milan

Sponsors (2)

Lead Sponsor Collaborator
IRCCS San Raffaele Servier

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary BH2 and BH4 levels (ng/ml) in plasma and platelets Blood samples will be withdrawn and subsequently analyzed to assess biopterins BH4 and BH2 ng/mL concentration in plasma and platelets Each will be determined separately from the same sample, by high-performance liquid chromatography followed by serial electrochemical and fluorescent detection. 1 week
Primary Coronary Flow Reserve (CFR) Trans Thoracic Doppler Echocardiography Measurement of coronary flow reserve of the left anterior descending coronary artery will be carried out with transthoracic Doppler Echocardiography (TDE) and dipyridamole stress. CFR will be calculated as the ratio between stress and resting flow velocity (cm/sec) 1 week
Primary Relationship between coronary flow reserve (CFR) and platelet/plasma BH2 and BH4 levels. Simple regression analysis or logistic regression will be used to test the relationship between CFR and biopterins values in plasma and platelets. 1 week
Secondary Levels of cGMP in platelets Comparison of levels of cGMP in platelets among normals, patients with normal CFR and patients with reduced CFR 1 week
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