Angina PectorisANFIBIONCT05374694
Angina, Physiology, Biology (ANgina, FIsiologia BIOlogia)
An observational study of Angina Pectoris, run by Hospital Arnau de Vilanova at 1 site in Spain.
Trial summary
Relationship between invasive physiological assessment with FFR and IMR and biological markers as micro-RNA's according to coronary vascular compartiment affected (Group 1: Macrovasculature + / Microvasculature +; Group 2: Macrovasculature + / Microvasculature -; Group 3: Macrovasculature - / Microvasculature +; Group… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina Pectoris
- What is being tested?
- Physiological invasive coronary evaluation
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 8 May 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with angor pectoris referred for coronary angiography after excluding other cardiaca and non-cardiac causes of chest pain
Who may be able to join
- Age ≥ 18 years.
- Patients with chest pain suggestive of angina evaluated by a cardiologist referred for diagnostic coronary angiography and possible coronary intervention.
- Echocardiogram ruling out noncoronary cardiac causes of chest pain.
- Informed consent.
Who cannot join
- Contrast allergy not susceptible to premedication.
- Severe bronchial asthma or adenosine intolerance.
- Atrio-ventricular block (≥ 2nd degree) or acetylcholine intolerance.
- Acute myocardial infarction with ST-segment elevation.
- Acute myocardial infarction without ST-segment elevation.
- Cardiogenic shock.
Show all 12Show fewer
- Total occlusion of any coronary artery that precludes measurements with pressure-temperature guidewires.
- Previous coronary artery bypass grafting.
- Women with the possibility of being pregnant.
- Renal dysfunction with an estimated glomerular filtration rate <30 mL/min/1.73m2.
- Inability to understand the nature of the study and / or sign informed consent.
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Arnau de Vilanova
Lleida, Catalonia, 25198
Diego Fernández-Rodríguez, MD, PhD, 651369729, dfernandez.lleida.ics@gencat.cat
Lucía Matute-Blanco, MD, 679252830, lmatute.lleida.ics@gencat.cat
About this study
Official title: Epigenetic Characterization of Angina Pectoris According to the Affected Coronary Compartment: Relationship Between Invasive Physiological Coronary Evaluation and Micro-RNAs
Relationship between invasive physiological assessment with FFR and IMR and biological markers as micro-RNA's according to coronary vascular compartiment affected (Group 1: Macrovasculature + / Microvasculature +; Group 2: Macrovasculature + / Microvasculature -; Group 3: Macrovasculature - / Microvasculature +; Group 4: Macrovasculature - / Microvasculature -). Also, biological markers will be related with presence of microvascular spasm or macrovascular spasm (Group 5).
Read the detailed description
Patients with chest pain suggestive of angina after ruling out other cardiac and non-cardiac causes, referred for invasive coronary angiography, will be evaluated by coronary angiography and invasive coronary physiological assessment by determining FFR and IMR and by performing a vasoreactivity test with acetylcholine.
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
- Angina Pectoris
- Being tested
- Physiological invasive coronary evaluation
- Keywords
- Coronary physiology, Biology, miRNA, Fractional flow reserve, Index of microcirculatory resistance, Angina pectoris
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiological invasive coronary evaluationDiagnostic test
Performance of FFR, IMR and acetylcholine test (Only patients in groups 3 and 4 will undergo the acetylcholine test)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Macrovasculature + (FFR ≤ 0.80) / Microvasculature + (IMR ≥25) Receives: Diagnostic Test: Physiological invasive coronary evaluation | |
| Group 2 | Macrovasculature + (FFR ≤ 0.80) / Microvasculature - (IMR <25) Receives: Diagnostic Test: Physiological invasive coronary evaluation | |
| Group 3 | Macrovasculature - (FFR>0.80) / Microvasculature + (IMR ≥25) Receives: Diagnostic Test: Physiological invasive coronary evaluation | |
| Group 4 | Macrovasculature - (FFR>0.80) / Microvasculature - (IMR <25) Receives: Diagnostic Test: Physiological invasive coronary evaluation | |
| 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. Receives: Diagnostic Test: Physiological invasive coronary evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
FFR
Fractional flow reserve
Measured: Intraprocedure
IMR
Index of microvascular resistance
Measured: Intraprocedure
Ach
Acetilcholine test
Measured: Intraprocedure
Secondary outcomes (1)
QCA
Quantitative Coronary Angiography
Measured: Intraprocedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start8 May 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Angina PectorisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Arnau de Vilanova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego Fernández-Rodríguez, Hospital Arnau de Vilanova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374694
- Sponsor's protocol ID
- CEIC-2665
- Acronym
- ANFIBIO
- Status last verified
- Oct 2022
- First submitted
- 5 May 2022
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Matute-Blanco L, Sanchez-Rodriguez M, Casanova-Sandoval J, Garcia-Guimaraes M, Rivera K, Fuertes-Ferre G, Guerrero AP, Segovia RM, Belmonte T, Benitez ID, Molinero M, Barbe F, Worner F, Bardaji A, Fernandez-Rodriguez D, de Gonzalo-Calvo D. Plasma miR-502-5p and coronary artery vasospasm: An exploratory study. Clin Investig Arterioscler. 2026 May 28:500947. doi: 10.1016/j.arteri.2026.500947. Online ahead of print. English, Spanish.
PubMed 42209331
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epigenetic Characterization of Angina Pectoris According to the Affected Coronary Compartment: Relationship Between Invasive Physiological Coronary Evaluation and Micro-RNAs
- ClinicalTrials.gov ID
- NCT05374694
- Acronym / sponsor ID
- ANFIBIO / CEIC-2665
- Conditions
- Angina Pectoris
- Keywords
- Coronary physiology, Biology, miRNA, Fractional flow reserve, Index of microcirculatory resistance, Angina pectoris
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital Arnau de VilanovaUniversity, hospital or other
- Study start
- 8 May 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 16 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Relationship between invasive physiological assessment with FFR and IMR and biological markers as micro-RNA's according to coronary vascular compartiment affected (Group 1: Macrovasculature + / Microvasculature +; Group 2: Macrovasculature + / Microvasculature -; Group 3: Macrovasculature - / Microvasculature +; Group 4: Macrovasculature - / Microvasculature -). Also, biological markers will be related with presence of microvascular spasm or macrovascular spasm (Group 5).
Detailed description
Patients with chest pain suggestive of angina after ruling out other cardiac and non-cardiac causes, referred for invasive coronary angiography, will be evaluated by coronary angiography and invasive coronary physiological assessment by determining FFR and IMR and by performing a vasoreactivity test with acetylcholine.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: Physiological invasive coronary evaluationMacrovasculature + (FFR ≤ 0.80) / Microvasculature + (IMR ≥25) |
| Group 2 | – | Diagnostic Test: Physiological invasive coronary evaluationMacrovasculature + (FFR ≤ 0.80) / Microvasculature - (IMR <25) |
| Group 3 | – | Diagnostic Test: Physiological invasive coronary evaluationMacrovasculature - (FFR>0.80) / Microvasculature + (IMR ≥25) |
| Group 4 | – | Diagnostic Test: Physiological invasive coronary evaluationMacrovasculature - (FFR>0.80) / Microvasculature - (IMR <25) |
| Group 5 | – | Diagnostic Test: Physiological invasive coronary evaluationMicrovascular 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with angor pectoris referred for coronary angiography after excluding other cardiaca and non-cardiac causes of chest pain
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Patients with chest pain suggestive of angina evaluated by a cardiologist referred for diagnostic coronary angiography and possible coronary intervention.
- Echocardiogram ruling out noncoronary cardiac causes of chest pain.
- Informed consent.
Key exclusion criteria (12 listed)
- Contrast allergy not susceptible to premedication.
- Severe bronchial asthma or adenosine intolerance.
- Atrio-ventricular block (≥ 2nd degree) or acetylcholine intolerance.
- Acute myocardial infarction with ST-segment elevation.
- Acute myocardial infarction without ST-segment elevation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiological invasive coronary evaluationPerformance of FFR, IMR and acetylcholine test (Only patients in groups 3 and 4 will undergo the acetylcholine test) | Diagnostic test | Group 1, Group 2, Group 3, Group 4, Group 5 |
Primary outcome
FFR
Time frame: Intraprocedure
Fractional flow reserve
IMR
Time frame: Intraprocedure
Index of microvascular resistance
Ach
Time frame: Intraprocedure
Acetilcholine test
1 secondary outcome
QCA
Time frame: Intraprocedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Derived from this study: PubMed 42209331Matute-Blanco L, Sanchez-Rodriguez M, Casanova-Sandoval J, Garcia-Guimaraes M, Rivera K, Fuertes-Ferre G, Guerrero AP, Segovia RM, Belmonte T, Benitez ID, Molinero M, Barbe F, Worner F, Bardaji A, Fernandez-Rodriguez D, de Gonzalo-Calvo D. Plasma miR-502-5p and coronary artery vasospasm: An exploratory study. Clin Investig Arterioscler. 2026 May 28:500947. doi: 10.1016/j.arteri.2026.500947. Online ahead of print. English, Spanish.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angina Pectoris, run by Hospital Arnau de Vilanova at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diego Fernández-Rodriguez, MD, PhD (+34-651369729, dfernandez.lleida.ics@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FFR (time frame: Intraprocedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05374694, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022.