Angina CCS Classe II-IV - IMR, RFR, FFR,CFRMiVaNCT05686707
Characterization of Different Phenotypes of Microvascular Dysfunction and Their Impact on Angina Severity in Patients With Chronic Angina in the Absence of Obstructive Coronary Artery Disease.
An observational study of Angina CCS Classe II-IV - IMR, RFR, FFR,CFR, run by Federico II University at 1 site in Italy.
Trial summary
The aim of the present study will be to identify different phenotypes of microvascular dysfunction and their associations with the severity of anginal symptoms assessed through the Seattle Angina Questionnaire(SAQ-7). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Angina CCS Classe II-IV - IMR, RFR, FFR,CFR
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 18 Jul 2022to 30 Jun 2025
- How long will I take part?
- 5 Years
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of both sexes, aged between 18 and 85 years, with clinical indication to perform a diagnostic coronary angiography, according to the current guidelines of the European Society of Cardiology will be enrolled. (ESC)
Who may be able to join
- Patients who meet all of the following criteria will be considered for study participation:
- Age ≥18 and <85 years. Chronic coronary syndrome (including patients with anginal equivalents) Angina CCS class II-IV Evidence of inducible reversible ischemia in noninvasive trials
- Availability of the following measurements:
- Microvascular resistance index (IMR)
- Quiescent full cycle flow ratio (RFR),
- fractional flow reserve (FFR),
- Coronary flow reserve (CFR) Willingness to participate and sign the informed consent document prior to the procedure.
Who cannot join
- At least one of the following:
- Pregnancy or breastfeeding. Medical or psychological conditions that would compromise proper and orderly participation.
- Left ejection fraction less than 30% Prior coronary artery bypass surgery (CABG) Decompensated congestive heart failure (CHF) Chronic or acute renal failure with creatinine >2mg/dl Severe valve disease Patients with comorbidities limiting life expectancy to less than one year.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Federico II University of Naples
Naples, 80131
Giovanni Esposito, MD PhD, 0817463075 ext. 0039, espogiov@unina.it
Giovanni Esposito, MD PhD
About this study
Official title: Characterization of Different Phenotypes of Microvascular Dysfunction and Their Impact on Angina Severity in Patients With Chronic Angina in the Absence of Obstructive Coronary Artery Disease
The aim of the present study will be to identify different phenotypes of microvascular dysfunction and their associations with the severity of anginal symptoms assessed through the Seattle Angina Questionnaire(SAQ-7).
Read the detailed description
After administration of unfractionated heparin (100UI/Kg), a special pressure guide (Pressure Wire X, Abbott), equipped with a distal sensor capable of measuring pressure and temperature, will be introduced inside the anterior descending branch (IVA) of the left coronary artery and hyperemia will be induced by intravenous infusion of adenosine. The IMR will be calculated using the thermodilution technique, and is given by the product between the mean distal pressure, in the left anterior descending coronary artery, and the mean transit time (Tmn) during maximal hyperemia.
During the procedure, additional coronary physiological indices will be calculated such as:
- Quiescent full cycle flow ratio (RFR), - Fractional flow reserve (FFR),
- Coronary flow reserve (CFR)
In order to identify different phenotypes of microvascular dysfunction, as follows:
- Phenotype A: Patients with IMR>25, CFR <2 and FFR>0.80 (concordant pure-microvascular pathological results)
- Phenotype B: patients with IMR>25, CFR>2 and FFR>0.80 (increased microvascular hyperemic resistance, maintenance of microvascular reactivity)
- Phenotype C: Patients with IMR 25, CFR 2 and FFR>0.80 (normal hyperemic resistance and reduced reactivity) All these phenotypes can also be combined with pathological FFR measures (<0.80) (phenotypes A1, B1, C1).
- Keywords
- CCS IMR, RFR, FFR,CFR
What is being measured
The primary outcome is the main question the study is designed to answer.
(SAQ-7)
Identify different phenotypes of microvascular dysfunction and their associations with anginal symptom severity assessed through the Seattle Angina Questionnaire (SAQ-7).
Measured: 12 months
Secondary outcomes (1)
characterization of the severity of angina
To validate the ability of the microvascular resistance index to identify patients who have microvascular disease and its utility in characterizing angina severity. Identify different phenotypes of microvascular dysfunction and their associations with comorbidities, cardiovascular risk factors, and drug therapy. A sub-analysis on the use of different antianginal drugs will be performed to better understand the impact of pharmacotherapy on different microvascular dysfunction phenotypes.
Evaluate the health status of patients in different microvascular dysfunction phenotypes through the EQ-5D-5L questionnaire.
EQ-5D is a standardized measure of health status developed by the EuroQoL Group in order to provide a simple and generic measure of health for clinical and economic evaluation.
Evaluate the state of depression induced by the disease through "The Brief Illness Perception Questionnaire (B-IPQ).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start18 Jul 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina CCS Classe II-IV - IMR, RFR, FFR,CFRStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Catanzaro, I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio, Università degli Studi di Ferrara, IRCCS Multimedica, Università di Siena, University of Parma, Universita di Verona, Ospedale Policlinico San Martino, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, A.O.U. Città della Salute e della Scienza, Azienda Policlinico Umberto I, Azienda Ospedaliero-Universitaria Careggi
- Responsible party
- Principal investigator, Giovanni Esposito, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686707
- Sponsor's protocol ID
- 333-21
- Acronym
- MiVa
- Status last verified
- Mar 2024
- First submitted
- 18 Jul 2022
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Different Phenotypes of Microvascular Dysfunction and Their Impact on Angina Severity in Patients With Chronic Angina in the Absence of Obstructive Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT05686707
- Acronym / sponsor ID
- MiVa / 333-21
- Keywords
- CCS IMR, RFR, FFR,CFR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Collaborators
- University of Catanzaro, I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio, Università degli Studi di Ferrara, IRCCS Multimedica, Università di Siena, University of Parma, Universita di Verona, Ospedale Policlinico San Martino, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, A.O.U. Città della Salute e della Scienza, Azienda Policlinico Umberto I, Azienda Ospedaliero-Universitaria Careggi
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 17 Jan 2023 (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.
The aim of the present study will be to identify different phenotypes of microvascular dysfunction and their associations with the severity of anginal symptoms assessed through the Seattle Angina Questionnaire(SAQ-7).
Detailed description
After administration of unfractionated heparin (100UI/Kg), a special pressure guide (Pressure Wire X, Abbott), equipped with a distal sensor capable of measuring pressure and temperature, will be introduced inside the anterior descending branch (IVA) of the left coronary artery and hyperemia will be induced by intravenous infusion of adenosine. The IMR will be calculated using the thermodilution technique, and is given by the product between the mean distal pressure, in the left anterior descending coronary artery, and the mean transit time (Tmn) during maximal hyperemia.
During the procedure, additional coronary physiological indices will be calculated such as:
- Quiescent full cycle flow ratio (RFR), - Fractional flow reserve (FFR),
- Coronary flow reserve (CFR)
In order to identify different phenotypes of microvascular dysfunction, as follows:
- Phenotype A: Patients with IMR>25, CFR <2 and FFR>0.80 (concordant pure-microvascular pathological results)
- Phenotype B: patients with IMR>25, CFR>2 and FFR>0.80 (increased microvascular hyperemic resistance, maintenance of microvascular reactivity)
- Phenotype C: Patients with IMR 25, CFR 2 and FFR>0.80 (normal hyperemic resistance and reduced reactivity) All these phenotypes can also be combined with pathological FFR measures (<0.80) (phenotypes A1, B1, C1).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of both sexes, aged between 18 and 85 years, with clinical indication to perform a diagnostic coronary angiography, according to the current guidelines of the European Society of Cardiology will be enrolled. (ESC)
Key inclusion criteria (7 listed)
- Patients who meet all of the following criteria will be considered for study participation:
- Age ≥18 and <85 years. Chronic coronary syndrome (including patients with anginal equivalents) Angina CCS class II-IV Evidence of inducible reversible ischemia in noninvasive trials
- Microvascular resistance index (IMR)
- Quiescent full cycle flow ratio (RFR),
- fractional flow reserve (FFR),
Key exclusion criteria (3 listed)
- Pregnancy or breastfeeding. Medical or psychological conditions that would compromise proper and orderly participation.
- Left ejection fraction less than 30% Prior coronary artery bypass surgery (CABG) Decompensated congestive heart failure (CHF) Chronic or acute renal failure with creatinine >2mg/dl Severe valve disease Patients with comorbidities limiting life expectancy to less than one year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
(SAQ-7)
Time frame: 12 months
Identify different phenotypes of microvascular dysfunction and their associations with anginal symptom severity assessed through the Seattle Angina Questionnaire (SAQ-7).
1 secondary outcome
characterization of the severity of angina
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
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 CCS Classe II-IV - IMR, RFR, FFR,CFR, run by Federico II University at 1 site in Italy.
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 7 inclusion and 3 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 6 Mar 2024. 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 Italy. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(SAQ-7) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2024.