Angina, Physiology, Biology (ANgina, FIsiologia BIOlogia)
NCT ID: NCT05374694
Last Updated: 2022-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2022-05-08
2023-12-31
Brief Summary
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Detailed Description
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A relationship will be established between the invasive physiological assessment with FFR and IMR and biological markers such as micro-RNA's according to the affected coronary vascular compartment (Group 1: Macrovasculature + / Microvasculature +; Group 2: Macrovasculature + / Microvasculature -; Group 3 : Macrovasculature - / Microvasculature +; Group 4: Macrovasculature - / Microvasculature -). In addition, the biological markers will be related to the presence of microvascular spasm or macrovascular spasm (Group 5).
Finally, among other biological markers, the following miRNAs will be compared. These miRNA's present consistent data in the literature about their over or underexpression.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Group 1
Macrovasculature + (FFR ≤ 0.80) / Microvasculature + (IMR ≥25)
Physiological invasive coronary evaluation
Performance of FFR, IMR and acetylcholine test (Only patients in groups 3 and 4 will undergo the acetylcholine test)
Group 2
Macrovasculature + (FFR ≤ 0.80) / Microvasculature - (IMR \<25)
Physiological invasive coronary evaluation
Performance of FFR, IMR and acetylcholine test (Only patients in groups 3 and 4 will undergo the acetylcholine test)
Group 3
Macrovasculature - (FFR\>0.80) / Microvasculature + (IMR ≥25)
Physiological invasive coronary evaluation
Performance of FFR, IMR and acetylcholine test (Only patients in groups 3 and 4 will undergo the acetylcholine test)
Group 4
Macrovasculature - (FFR\>0.80) / Microvasculature - (IMR \<25)
Physiological invasive coronary evaluation
Performance of FFR, IMR and acetylcholine test (Only patients in groups 3 and 4 will undergo the acetylcholine test)
Group 5
Microvascular spasm (\<90% diameter contraction, Chest pain, ECG changes) or Macrovascular spasm (\>90% diameter contraction, Chest pain, ECG changes)
\*Only patients in groups 3 and 4 will undergo the acetylcholine test.
Physiological invasive coronary evaluation
Performance of FFR, IMR and acetylcholine test (Only patients in groups 3 and 4 will undergo the acetylcholine test)
Interventions
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Physiological invasive coronary evaluation
Performance of FFR, IMR and acetylcholine test (Only patients in groups 3 and 4 will undergo the acetylcholine test)
Eligibility Criteria
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Inclusion Criteria
2. Patients with chest pain suggestive of angina evaluated by a cardiologist referred for diagnostic coronary angiography and possible coronary intervention.
3. Echocardiogram ruling out noncoronary cardiac causes of chest pain.
4. Informed consent.
Exclusion Criteria
2. Severe bronchial asthma or adenosine intolerance.
3. Atrio-ventricular block (≥ 2nd degree) or acetylcholine intolerance.
4. Acute myocardial infarction with ST-segment elevation.
5. Acute myocardial infarction without ST-segment elevation.
6. Cardiogenic shock.
7. Total occlusion of any coronary artery that precludes measurements with pressure-temperature guidewires.
8. Previous coronary artery bypass grafting.
9. Women with the possibility of being pregnant.
10. Renal dysfunction with an estimated glomerular filtration rate \<30 mL/min/1.73m2.
11. Inability to understand the nature of the study and / or sign informed consent.
12. Any other medical condition that, in the opinion of the researcher, may lead to safety issues for patients or may alter the results of the study.
18 Years
ALL
No
Sponsors
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Hospital Arnau de Vilanova
OTHER
Responsible Party
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Diego Fernández-Rodríguez
Principal Investigator
Locations
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Hospital Arnau de Vilanova
Lleida, Catalonia, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CEIC-2665
Identifier Type: -
Identifier Source: org_study_id
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