Angina, MicrovascularNOCAWTNCT07558018
Evaluation of the Systemic Microcirculation as a Surrogate for Coronary Microcirculation in Women With ANOCA
An observational study of Angina, Microvascular, run by National Institute of Cardiology, Laranjeiras, Brazil.
Trial summary
The primary objective of this project is to validate a multi-modal systemic microvascular phenotyping platform-combining Laser Speckle Contrast Imaging (LSCI) and Sublingual Handheld Videomicroscopy (IDF imaging)-as a non-invasive surrogate for coronary microvascular function in women with ANOCA (Angina with… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Angina, Microvascular
- What is being tested?
- Investigation of Systemic Endothelial Microvascular Function
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Dec 2029
- Phase
- Observational
- 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 to 65 years
- Women only
- Adult, Older adult
Study population: Patients from a terciary cardiology hospital.
Who may be able to join
- Age 18-65 years
- Anginal chest pain
Who cannot join
- Malignant neoplasms
- Autoimmune diseases
- Acute systemic diseases
- Pregnancy or lactation
- Iodine allergy
- CAD on invasive coronary angiography or coronary computed tomography angiography (CCTA)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Systemic Microcirculation as a Surrogate for Coronary Microcirculation in Women With ANOCA: Insights Into Pathophysiology and Diagnosis Using Noninvasive, Innovative Techniques (NOCAWT)
The primary objective of this project is to validate a multi-modal systemic microvascular phenotyping platform-combining Laser Speckle Contrast Imaging (LSCI) and Sublingual Handheld Videomicroscopy (IDF imaging)-as a non-invasive surrogate for coronary microvascular function in women with ANOCA (Angina with Non-Obstructive Coronary Arteries). We aim to demonstrate that systemic microvascular signatures (microvascular reactivity and density) can predict coronary endotypes with high accuracy, potentially reducing the need for invasive diagnostics.
Read the detailed description
The study will involve women aged 18 to 65 years, with stable anginal chest pain and no coronary artery disease (ANOCA) (absence of coronary plaque in coronary angiography or computed tomography coronary angiography - CCTA), recruited at the National Institute of Cardiology (INC). The upper age limit was established to limit the influence of vascular senescence on the results.
- Conditions
- Angina, Microvascular
- Being tested
- Investigation of Systemic Endothelial Microvascular Function
- Keywords
- microcirculation, Laser Speckle Contrast Imaging, Sublingual videomicroscopy
- Medical subject headings
- Microvascular Angina
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigation of Systemic Endothelial Microvascular FunctionProcedure or surgery
Also called Myocardial Perfusion Imaging, Sublingual videomicroscopy, Invasive coronary flow determination, Cutaneous Laser Speckle Contrast Imaging
Investigation of Systemic Endothelial Microvascular Function
| Study group | Role | What they receive |
|---|---|---|
| ANOCA | Symptomatic Group (ANOCA): n = 40 patients with stable angina and non-obstructive coronary arteries. Receives: Procedure: Investigation of Systemic Endothelial Microvascular Function | |
| CONTROL | Control Group: n = 20 age-matched women without chest pain and without CAD. Receives: Procedure: Investigation of Systemic Endothelial Microvascular Function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of endothelium-dependent skin microvascular reactivity.
Evaluation of systemic microvascular reactivity induced by endothelium-dependent agent (acetylcholine). Microvascular reactivity will be evaluated using a non-invasive and operator -independent methodology, named laser speckle contrast imaging, coupled with skin iontophoresis of vasodilator agents. Cutaneous microvascular flow will be measured in arbitrary perfusion units, divided by mean arterial pressure, to yield cutaneous vascular conductance.
Measured: Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.
Secondary outcomes (3)
Evaluation of endothelium-independent skin microvascular reactivity.
Evaluation of systemic microvascular reactivity induced by endothelium-independent agent (sodium nitroprusside). Microvascular reactivity will be evaluated using a non-invasive and operator -independent methodology, named laser speckle contrast imaging, coupled with skin iontophoresis of vasodilator agents. Cutaneous microvascular flow will be measured in arbitrary perfusion units, divided by mean arterial pressure, to yield cutaneous vascular conductance.
Measured: Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.
Evaluation of endothelium-dependent skin microvascular reactivity.
Evaluation of systemic microvascular reactivity induced by postocclusive reactive hyperemia. Microvascular reactivity will be evaluated using a non-invasive and operator -independent methodology, named laser speckle contrast imaging. Cutaneous microvascular flow will be measured in arbitrary perfusion units, divided by mean arterial pressure, to yield cutaneous vascular conductance.
Measured: Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.
Evaluation of sublingual microcirculation.
Sublingual microcirculatory density and perfusion will be assessed using a handheld camera based on incident dark-field (IDF) imaging.
Measured: Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.
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 startAug 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina, MicrovascularStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Laranjeiras, Brazil
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eduardo Tibirica, MD, PhD, National Institute of Cardiology, Laranjeiras, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558018
- Sponsor's protocol ID
- NOCoronaryArtery Women Testing
- Acronym
- NOCAWT
- Status last verified
- May 2026
- First submitted
- 22 Apr 2026
- Last updated
- 5 May 2026
- 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 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Systemic Microcirculation as a Surrogate for Coronary Microcirculation in Women With ANOCA: Insights Into Pathophysiology and Diagnosis Using Noninvasive, Innovative Techniques (NOCAWT)
- ClinicalTrials.gov ID
- NCT07558018
- Acronym / sponsor ID
- NOCAWT / NOCoronaryArtery Women Testing
- Conditions
- Angina, Microvascular
- Keywords
- microcirculation, Laser Speckle Contrast Imaging, Sublingual videomicroscopy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Institute of Cardiology, Laranjeiras, BrazilOther government
- Study start
- Aug 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (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.
The primary objective of this project is to validate a multi-modal systemic microvascular phenotyping platform-combining Laser Speckle Contrast Imaging (LSCI) and Sublingual Handheld Videomicroscopy (IDF imaging)-as a non-invasive surrogate for coronary microvascular function in women with ANOCA (Angina with Non-Obstructive Coronary Arteries). We aim to demonstrate that systemic microvascular signatures (microvascular reactivity and density) can predict coronary endotypes with high accuracy, potentially reducing the need for invasive diagnostics.
Detailed description
The study will involve women aged 18 to 65 years, with stable anginal chest pain and no coronary artery disease (ANOCA) (absence of coronary plaque in coronary angiography or computed tomography coronary angiography - CCTA), recruited at the National Institute of Cardiology (INC). The upper age limit was established to limit the influence of vascular senescence on the results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ANOCA | – | Procedure: Investigation of Systemic Endothelial Microvascular FunctionSymptomatic Group (ANOCA): n = 40 patients with stable angina and non-obstructive coronary arteries. |
| CONTROL | – | Procedure: Investigation of Systemic Endothelial Microvascular FunctionControl Group: n = 20 age-matched women without chest pain and without CAD. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients from a terciary cardiology hospital.
Key inclusion criteria (2 listed)
- Age 18-65 years
- Anginal chest pain
Key exclusion criteria (6 listed)
- Malignant neoplasms
- Autoimmune diseases
- Acute systemic diseases
- Pregnancy or lactation
- Iodine allergy
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 |
|---|---|---|
| Investigation of Systemic Endothelial Microvascular FunctionAlso: Myocardial Perfusion Imaging, Sublingual videomicroscopy, Invasive coronary flow determination, Cutaneous Laser Speckle Contrast ImagingInvestigation of Systemic Endothelial Microvascular Function | Procedure or surgery | ANOCA, CONTROL |
Primary outcome
Evaluation of endothelium-dependent skin microvascular reactivity.
Time frame: Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.
Evaluation of systemic microvascular reactivity induced by endothelium-dependent agent (acetylcholine). Microvascular reactivity will be evaluated using a non-invasive and operator -independent methodology, named laser speckle contrast imaging, coupled with skin iontophoresis of vasodilator agents. Cutaneous microvascular flow will be measured in arbitrary perfusion units, divided by mean arterial pressure, to yield cutaneous vascular conductance.
3 secondary outcomes
Evaluation of endothelium-independent skin microvascular reactivity.
Time frame: Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.
Evaluation of endothelium-dependent skin microvascular reactivity.
Time frame: Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.
Evaluation of sublingual microcirculation.
Time frame: Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.
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 5 May 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Angina, Microvascular, run by National Institute of Cardiology, Laranjeiras, Brazil.
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 2 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: opening soon, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Contact Eduardo Tibirica, MD, PhD (+55-21-99914-6075, etibi@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of endothelium-dependent skin microvascular reactivity. (time frame: Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.). 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 5 May 2026.