Angina (Stable)NCT07559994
Diagnostic and Clinical Management of Non-Obstructive Myocardial Ischemia in Patients With Long Covid-19 Syndrome and New Onset Chest Pain
A study testing Coronary functional test in people with Angina (Stable) and INOCA (Ischemia With Non Obstructive Coronary Artery Disease), run by Fundacion Investigacion Interhospitalaria Cardiovascular at 1 site in Spain.
Trial summary
Long Covid-19 INOCA is an investigator-initiated, prospective, randomized, sham-controlled, single center study. Its objective is to investigate the benefits of tailored medical therapy according to the results of the coronary functional testing (CFT) against the routine standard of care and the prevalence and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina (Stable), INOCA (Ischemia With Non Obstructive Coronary Artery Disease), Long COVID-19 Syndrome
- What is being tested?
- Coronary functional test
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteSpain
- Study dates
- 2 Sep 2021to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- All patients with the history of SARS-CoV-2 infection, either with acute infection confirmed by PCR or antigen testing, or with past infection demonstrated by serological testing, with symptoms suggestive of LCS such as post exertional malaise, persistent fatigue, difficulty concentrating or shortness of breath who present with typical angina or angina equivalent chest pain starting after SARS-CoV2 infection
Who cannot join
- Previously been diagnosed with coronary artery disease
- Severe left ventricular systolic dysfunction (LVEF) < 30%
- Any moderate to severe concomitant structural heart disease (e.g. moderate to severe valvular heart abnormalities, severe left ventricular hypertrophy)
- Severely reduced renal function (glomerular filtration rate < 30 ml/min/1.73m2)
- Contraindications to the administration of Adenosine or Acetylcholine
- A life expectancy of less than 2 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic and Clinical Management of Non-Obstructive Myocardial Ischemia in Patients With Long Covid-19 Syndrome and New Onset Chest Pain: the Long Covid-19 INOCA Trial
Long Covid-19 INOCA is an investigator-initiated, prospective, randomized, sham-controlled, single center study. Its objective is to investigate the benefits of tailored medical therapy according to the results of the coronary functional testing (CFT) against the routine standard of care and the prevalence and endotypes of ischemia with non-obstructive coronary arteries (INOCA) in patients with long covid-19 syndrome (LCS) and new onset chest pain. All LCS patient with new onset of chest pain will be enrolled. Invasive coronary angiogram and epicardial physiological assessment will be performed to exclude significant epicardial coronary artery disease. Patients without significant epicardial coronary artery disease will undergo CFT which include Acetylcholine test and Coronary microvascular function test. Patients will be randomized into 2 groups: 1) tailored treatment group guided by the results of CFT (intervention) and 2) the routine standard of care group (sham). All patients will undergo the angina symptom and the quality-of-life (QoL) assessment at baseline, 3, and 12 months using the Seattle Angina Questionnaire (SAQ). In the sham group, patients and physicians will be blinded to the results of coronary functional testing for 3 months. Treatment of INOCA will be provided in both groups. The main hypothesis of the Long-Covid INOCA study states that, in LCS patients with chest pain, treatment guided by CFT will demonstrate better angina symptom control and improvement in quality of life (QoL) comparing to the routine standard of care.
Read the detailed description
Long Covid-19 INOCA is an investigator-initiated, prospective, randomized, sham-controlled, single center study intended to compare the benefits in angina symptom and Quality of Life assessed by the Seattle Angina Questionnaire (SAQ) between tailored medical therapy guided by the results of the coronary functional testing (CFT) and the routine standard of care in patient with LCS and new onset of chest pain. Secondary objective is to investigate the prevalence and endotypes of INOCA in LCS patients with chest pain. This study will be conducted at Hospital Clínico San Carlos, Madrid, Spain.
All patients with the history of SARS-CoV-2 infection, either with acute infection confirmed by PCR or antigen testing, or with past infection demonstrated by serological testing, with symptoms suggestive of LCS such as post exertional malaise, persistent fatigue, difficulty concentrating or shortness of breath who present with typical angina or angina equivalent chest pain starting after SARS-CoV2 infection will be enrolled in this study.
After obtaining patient's informed consent. patients will be randomized by simple randomization in a 1:1 ratio using a central online module to 1) tailored treatment guided by the results of CFT (intervention) or 2) the routine standard of care treatment (sham). All patients will undergo an invasive coronary angiogram as a first step. Patients with severe epicardial coronary artery stenosis define by stenosis ≥ 90% by angiogram will be excluded for further testing. Patients with intermediate coronary artery stenosis will undergo a wire-based physiological assessment of epicardial stenosis. If there is a significant epicardial coronary artery disease defined by fractional flow reserve (FFR) ≤ 0.80 or non-hyperemic pressure ratio (NPHR) ≤ 0.89, the patients will be excluded for further testing. In patients without significant epicardial coronary artery disease, coronary functional testing which include coronary microvascular dysfunction test and Acetylcholine test will be performed. Both tests will be performed in a standard fashion according to the protocol from the guidelines. The results of the CFT will be reported as follow: 1) normal coronary functional testing 2) vasomotor disorder (including both epicardial and microvascular) 3) coronary microvascular dysfunction (including both structural and functional) and 4) combined vasomotor disorder and coronary microvascular dysfunction.
All patients will receive the medications for treatment of INOCA at an out-patient clinic. In intervention group, patient and physician will receive the CFT's results and medications will be prescribed according to patient's type of INOCA and follow with the recommendations in the EAPCI Consensus Document on INOCA and ESC Guidelines. In sham group, patient and physician will be blinded from the CFT's results for 3 months and medications will be prescribed according to physician's decision during this period. After 3 months, the CFT's result will be given to all patients and the treatment will follow with the recommendations from the guideline. Angina symptom and Quality of life in both groups will be assessed by the Seattle Questionnaire of Angina (SAQ), Duke Activity Status Index (DASI) and Euro-Quality of life 5D (EQ-5D) at baseline and each follow up which will occur at 3, and 12 months.
- Conditions
- Angina (Stable), INOCA (Ischemia With Non Obstructive Coronary Artery Disease), Long COVID-19 Syndrome
- Being tested
- Coronary functional test
- Keywords
- Chest pain, Ischemia with non obstructive coronary artery disease, Long COVID-19 Syndrome, Coronary functional testing
- Medical subject headings
- Angina, Stable, Post-Acute COVID-19 Syndrome, Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary functional testDiagnostic test
CFT will be reported as follow: 1) normal coronary functional testing 2) vasomotor disorder (including both epicardial and microvascular) 3) coronary microvascular dysfunction (including both structural and functional) and 4) combined vasomotor disorder and coronary microvascular dysfunction.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Treatment of INOCA guided by the results of the coronary functional testing during the entire follow up period (12 months) Receives: Diagnostic Test: Coronary functional test |
| Sham | Sham comparator | Treatment of INOCA by the routine standard of care for the first 3 months and guided by the results of the coronary functional testing during the rest of the follow up period (9 months) Receives: Diagnostic Test: Coronary functional test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes in angina symptom and quality of life assessed by Seattle Questionnaire of Angina score in the treatment guided group comparing to the standard of care group
The Seattle Angina Questionnaire (SAQ) measures 5 dimensions of coronary artery disease (physical limit, stability, frequency, satisfaction, disease perception) on a 0-100 scale, where higher scores indicate better health status. Scores are interpreted as: 0-24 (Poor), 25-49 (Fair), 50-74 (Good), 75-100 (Excellent).
Measured: From the date of enrollment to the end of follow up period at 12 months
Secondary outcomes (1)
The prevalence and type of INOCA in LCS patients with chest pain
INOCA can be diagnosed by Functional coronary testing if there is an evidence of vasomotor disorder (Epicardial or microvascular) from acetylcholine test and/or coronary microvascular dysfunction defined by coronary flow reserve less than 2.5 during hyperemia.
Measured: From the date of enrollment to the last follow up period at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start2 Sep 2021
- Primary completion30 Apr 2025
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Angina (Stable)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- INOCA treatment guided by the results of coronary functional test
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Investigacion Interhospitalaria Cardiovascular
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Principal investigator, Javier Escaned, Hospital San Carlos, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07559994
- Sponsor's protocol ID
- PI21/01481
- Status last verified
- May 2026
- First submitted
- 28 Apr 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.
PubMed 32644129The Lancet. Facing up to long COVID. Lancet. 2020 Dec 12;396(10266):1861. doi: 10.1016/S0140-6736(20)32662-3. No abstract available.
PubMed 33308453Varga Z, Flammer AJ, Steiger P, Haberecker M, Andermatt R, Zinkernagel AS, Mehra MR, Schuepbach RA, Ruschitzka F, Moch H. Endothelial cell infection and endotheliitis in COVID-19. Lancet. 2020 May 2;395(10234):1417-1418. doi: 10.1016/S0140-6736(20)30937-5. Epub 2020 Apr 21. No abstract available.
PubMed 32325026Kunadian V, Chieffo A, Camici PG, Berry C, Escaned J, Maas AHEM, Prescott E, Karam N, Appelman Y, Fraccaro C, Louise Buchanan G, Manzo-Silberman S, Al-Lamee R, Regar E, Lansky A, Abbott JD, Badimon L, Duncker DJ, Mehran R, Capodanno D, Baumbach A. An EAPCI Expert Consensus Document on Ischaemia with Non-Obstructive Coronary Arteries in Collaboration with European Society of Cardiology Working Group on Coronary Pathophysiology & Microcirculation Endorsed by Coronary Vasomotor Disorders International Study Group. Eur Heart J. 2020 Oct 1;41(37):3504-3520. doi: 10.1093/eurheartj/ehaa503.
PubMed 32626906Ahmed AI, Saad JM, Han Y, Alahdab F, Malahfji M, Nabi F, Mahmarian JJ, Cooke JP, Zoghbi WA, Al-Mallah MH. Coronary Microvascular Health in Patients With Prior COVID-19 Infection. JACC Cardiovasc Imaging. 2022 Dec;15(12):2153-2155. doi: 10.1016/j.jcmg.2022.07.006. Epub 2022 Aug 17. No abstract available.
PubMed 36481086Ford TJ, Stanley B, Sidik N, Good R, Rocchiccioli P, McEntegart M, Watkins S, Eteiba H, Shaukat A, Lindsay M, Robertson K, Hood S, McGeoch R, McDade R, Yii E, McCartney P, Corcoran D, Collison D, Rush C, Sattar N, McConnachie A, Touyz RM, Oldroyd KG, Berry C. 1-Year Outcomes of Angina Management Guided by Invasive Coronary Function Testing (CorMicA). JACC Cardiovasc Interv. 2020 Jan 13;13(1):33-45. doi: 10.1016/j.jcin.2019.11.001. Epub 2019 Nov 11.
PubMed 31709984
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Clinical Management of Non-Obstructive Myocardial Ischemia in Patients With Long Covid-19 Syndrome and New Onset Chest Pain: the Long Covid-19 INOCA Trial
- ClinicalTrials.gov ID
- NCT07559994
- Acronym / sponsor ID
- PI21/01481
- Conditions
- Angina (Stable), INOCA (Ischemia With Non Obstructive Coronary Artery Disease), Long COVID-19 Syndrome
- Keywords
- Chest pain, Ischemia with non obstructive coronary artery disease, Long COVID-19 Syndrome, Coronary functional testing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Fundacion Investigacion Interhospitalaria CardiovascularUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 30 Apr 2026 (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.
Long Covid-19 INOCA is an investigator-initiated, prospective, randomized, sham-controlled, single center study. Its objective is to investigate the benefits of tailored medical therapy according to the results of the coronary functional testing (CFT) against the routine standard of care and the prevalence and endotypes of ischemia with non-obstructive coronary arteries (INOCA) in patients with long covid-19 syndrome (LCS) and new onset chest pain. All LCS patient with new onset of chest pain will be enrolled. Invasive coronary angiogram and epicardial physiological assessment will be performed to exclude significant epicardial coronary artery disease. Patients without significant epicardial coronary artery disease will undergo CFT which include Acetylcholine test and Coronary microvascular function test. Patients will be randomized into 2 groups: 1) tailored treatment group guided by the results of CFT (intervention) and 2) the routine standard of care group (sham). All patients will undergo the angina symptom and the quality-of-life (QoL) assessment at baseline, 3, and 12 months using the Seattle Angina Questionnaire (SAQ). In the sham group, patients and physicians will be blinded to the results of coronary functional testing for 3 months. Treatment of INOCA will be provided in both groups. The main hypothesis of the Long-Covid INOCA study states that, in LCS patients with chest pain, treatment guided by CFT will demonstrate better angina symptom control and improvement in quality of life (QoL) comparing to the routine standard of care.
Detailed description
Long Covid-19 INOCA is an investigator-initiated, prospective, randomized, sham-controlled, single center study intended to compare the benefits in angina symptom and Quality of Life assessed by the Seattle Angina Questionnaire (SAQ) between tailored medical therapy guided by the results of the coronary functional testing (CFT) and the routine standard of care in patient with LCS and new onset of chest pain. Secondary objective is to investigate the prevalence and endotypes of INOCA in LCS patients with chest pain. This study will be conducted at Hospital Clínico San Carlos, Madrid, Spain.
All patients with the history of SARS-CoV-2 infection, either with acute infection confirmed by PCR or antigen testing, or with past infection demonstrated by serological testing, with symptoms suggestive of LCS such as post exertional malaise, persistent fatigue, difficulty concentrating or shortness of breath who present with typical angina or angina equivalent chest pain starting after SARS-CoV2 infection will be enrolled in this study.
After obtaining patient's informed consent. patients will be randomized by simple randomization in a 1:1 ratio using a central online module to 1) tailored treatment guided by the results of CFT (intervention) or 2) the routine standard of care treatment (sham). All patients will undergo an invasive coronary angiogram as a first step. Patients with severe epicardial coronary artery stenosis define by stenosis ≥ 90% by angiogram will be excluded for further testing. Patients with intermediate coronary artery stenosis will undergo a wire-based physiological assessment of epicardial stenosis. If there is a significant epicardial coronary artery disease defined by fractional flow reserve (FFR) ≤ 0.80 or non-hyperemic pressure ratio (NPHR) ≤ 0.89, the patients will be excluded for further testing. In patients without significant epicardial coronary artery disease, coronary functional testing which include coronary microvascular dysfunction test and Acetylcholine test will be performed. Both tests will be performed in a standard fashion according to the protocol from the guidelines. The results of the CFT will be reported as follow: 1) normal coronary functional testing 2) vasomotor disorder (including both epicardial and microvascular) 3) coronary microvascular dysfunction (including both structural and functional) and 4) combined vasomotor disorder and coronary microvascular dysfunction.
All patients will receive the medications for treatment of INOCA at an out-patient clinic. In intervention group, patient and physician will receive the CFT's results and medications will be prescribed according to patient's type of INOCA and follow with the recommendations in the EAPCI Consensus Document on INOCA and ESC Guidelines. In sham group, patient and physician will be blinded from the CFT's results for 3 months and medications will be prescribed according to physician's decision during this period. After 3 months, the CFT's result will be given to all patients and the treatment will follow with the recommendations from the guideline. Angina symptom and Quality of life in both groups will be assessed by the Seattle Questionnaire of Angina (SAQ), Duke Activity Status Index (DASI) and Euro-Quality of life 5D (EQ-5D) at baseline and each follow up which will occur at 3, and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- INOCA treatment guided by the results of coronary functional test
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Diagnostic Test: Coronary functional testTreatment of INOCA guided by the results of the coronary functional testing during the entire follow up period (12 months) |
| Sham | Sham comparator | Diagnostic Test: Coronary functional testTreatment of INOCA by the routine standard of care for the first 3 months and guided by the results of the coronary functional testing during the rest of the follow up period (9 months) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with the history of SARS-CoV-2 infection, either with acute infection confirmed by PCR or antigen testing, or with past infection demonstrated by serological testing, with symptoms suggestive of LCS such as post exertional malaise, persistent fatigue, difficulty concentrating or shortness of breath who present with typical angina or angina equivalent chest pain starting after SARS-CoV2 infection
Key exclusion criteria (6 listed)
- Previously been diagnosed with coronary artery disease
- Severe left ventricular systolic dysfunction (LVEF) < 30%
- Any moderate to severe concomitant structural heart disease (e.g. moderate to severe valvular heart abnormalities, severe left ventricular hypertrophy)
- Severely reduced renal function (glomerular filtration rate < 30 ml/min/1.73m2)
- Contraindications to the administration of Adenosine or Acetylcholine
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 |
|---|---|---|
| Coronary functional testCFT will be reported as follow: 1) normal coronary functional testing 2) vasomotor disorder (including both epicardial and microvascular) 3) coronary microvascular dysfunction (including both structural and functional) and 4) combined vasomotor disorder and coronary microvascular dysfunction. | Diagnostic test | Intervention, Sham |
Primary outcome
The changes in angina symptom and quality of life assessed by Seattle Questionnaire of Angina score in the treatment guided group comparing to the standard of care group
Time frame: From the date of enrollment to the end of follow up period at 12 months
The Seattle Angina Questionnaire (SAQ) measures 5 dimensions of coronary artery disease (physical limit, stability, frequency, satisfaction, disease perception) on a 0-100 scale, where higher scores indicate better health status. Scores are interpreted as: 0-24 (Poor), 25-49 (Fair), 50-74 (Good), 75-100 (Excellent).
1 secondary outcome
The prevalence and type of INOCA in LCS patients with chest pain
Time frame: From the date of enrollment to the last follow up period at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Background: PubMed 32644129Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.
- Background: PubMed 33308453The Lancet. Facing up to long COVID. Lancet. 2020 Dec 12;396(10266):1861. doi: 10.1016/S0140-6736(20)32662-3. No abstract available.
- Background: PubMed 32325026Varga Z, Flammer AJ, Steiger P, Haberecker M, Andermatt R, Zinkernagel AS, Mehra MR, Schuepbach RA, Ruschitzka F, Moch H. Endothelial cell infection and endotheliitis in COVID-19. Lancet. 2020 May 2;395(10234):1417-1418. doi: 10.1016/S0140-6736(20)30937-5. Epub 2020 Apr 21. No abstract available.
- Background: PubMed 32626906Kunadian V, Chieffo A, Camici PG, Berry C, Escaned J, Maas AHEM, Prescott E, Karam N, Appelman Y, Fraccaro C, Louise Buchanan G, Manzo-Silberman S, Al-Lamee R, Regar E, Lansky A, Abbott JD, Badimon L, Duncker DJ, Mehran R, Capodanno D, Baumbach A. An EAPCI Expert Consensus Document on Ischaemia with Non-Obstructive Coronary Arteries in Collaboration with European Society of Cardiology Working Group on Coronary Pathophysiology & Microcirculation Endorsed by Coronary Vasomotor Disorders International Study Group. Eur Heart J. 2020 Oct 1;41(37):3504-3520. doi: 10.1093/eurheartj/ehaa503.
- Background: PubMed 36481086Ahmed AI, Saad JM, Han Y, Alahdab F, Malahfji M, Nabi F, Mahmarian JJ, Cooke JP, Zoghbi WA, Al-Mallah MH. Coronary Microvascular Health in Patients With Prior COVID-19 Infection. JACC Cardiovasc Imaging. 2022 Dec;15(12):2153-2155. doi: 10.1016/j.jcmg.2022.07.006. Epub 2022 Aug 17. No abstract available.
- Background: PubMed 31709984Ford TJ, Stanley B, Sidik N, Good R, Rocchiccioli P, McEntegart M, Watkins S, Eteiba H, Shaukat A, Lindsay M, Robertson K, Hood S, McGeoch R, McDade R, Yii E, McCartney P, Corcoran D, Collison D, Rush C, Sattar N, McConnachie A, Touyz RM, Oldroyd KG, Berry C. 1-Year Outcomes of Angina Management Guided by Invasive Coronary Function Testing (CorMicA). JACC Cardiovasc Interv. 2020 Jan 13;13(1):33-45. doi: 10.1016/j.jcin.2019.11.001. Epub 2019 Nov 11.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary functional test in people with Angina (Stable) and INOCA (Ischemia With Non Obstructive Coronary Artery Disease), run by Fundacion Investigacion Interhospitalaria Cardiovascular 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 1 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 28 May 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes in angina symptom and quality of life assessed by Seattle Questionnaire of Angina score in the treatment guided group comparing to the standard of care group (time frame: From the date of enrollment to the end of follow up period at 12 months). 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 NCT07559994, which also lists 6 linked publications.
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 28 May 2026.