Ischemic Heart DiseaseC3NCT04131075
The Cerebral-Coronary Connection (C3) Study
An observational study of Ischemic Heart Disease and Microvascular Coronary Artery Disease, run by Instituto de Salud Carlos III at 1 site in Spain.
Trial summary
This is a prospective cohort blinded study with the aim to investigate the prevalence and clinical impact of coronary microcirculatory dysfunction (CMD) in patients with ischemic heart disease, and its association with cerebral small vessel disease (CSVD) and depressive disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease, Microvascular Coronary Artery Disease, Depression
- What is being tested?
- Coronary Angiography and Multimodal Coronary Physiology Study (FFR, CFR, HMR)
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2017to 31 Mar 2020
- 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 stable coronary lesions (stable coronary disease or lesions in non-culprit vessels >48 hours after acute coronary syndrome) with clinical indication to coronary angiography and intermediate coronary lesions (visual estimation) suitable for FFR-guided revascularization.
Who may be able to join
- Informed Consent available.
- Age ≥ 18 years.
- Stable coronary lesions.
- Indication to FFR: ≥ 1 intermediate coronary lesion (40-80% diameter stenosis) in a principal/secondary vessel with ≥ 2 mm reference diameter.
Who cannot join
- Previous myocardial infarction in the territory of distribution of the target vessel.
- Coronary Left Main severe stenosis.
- Aortic valve stenosis (moderate or severe) .
- Severe left ventricle hypertrophy.
- Left ventricle moderate systolic dysfunction (EF < 35%).
- Contraindications to adenosine.
Show all 17Show fewer
- Previous CABG with permeable grafts.
- Contraindication to stent implantation.
- Severe anemia.
- Coagulopathies or chronic anticoagulation.
- Platelets < 75000 o > 700.000.
- Previous stroke or intracranial hemorrhage.
- Contraindication to MRI.
- Chronic Renal Failure contraindicating gadolinium infusion during MRI: eGFR < 60 ml/min), hemodialysis, previous renal transplantation.
- Pacemaker/ Implantable Cardioverter Device with contraindication to MRI.
- Planned cardiac surgery.
- Life expectancy < 2 years.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínico San Carlos
Madrid, 28040
Javier Escaned, MD, PhD, +34913303438, javier.escaned@salud.madrid.org
Carolina Espejo, MD, +34913303438, carolina.espejo.paeres@gmail.com
About this study
Official title: Microcirculatory Dysfunction in Stable Coronary Artery Disease: Relationship With Patient-focused Outcomes, Cerebral Small Vessel Disease and Depression.
This is a prospective cohort blinded study with the aim to investigate the prevalence and clinical impact of coronary microcirculatory dysfunction (CMD) in patients with ischemic heart disease, and its association with cerebral small vessel disease (CSVD) and depressive disorders. In addition, CMD and CSVD linkage to systemic inflammation and endothelial function will also be investigated.
Read the detailed description
The treatment of stable CAD is largely based on a paradigm that gives epicardial coronary stenoses a central role in the generation of myocardial ischaemia. However, coronary microcirculatory dysfunction (CMD) is a major and frequently ignored cause of ischaemia that, according to retrospective studies, influences the outcomes of patients with CAD. In addition, patients with CMD may not experience symptomatic relief with myocardial revascularization or pharmacological treatment. This constitutes one of the causes of persistent angina despite successful revascularization, causing not only an impairment of the quality of life and higher consumption of healthcare resources, but potentially affective disorders like depression, which has been found to be associated with CAD and with prognosis.
It also remains largely unknown whether CMD in stable CAD is organ-specific only or rather indicative of involvement of other vital organs. While this seems to be the case in the kidney and the retina, the relationship between CMD in the heart and the brain has not been studied. Beyond classical cardiovascular risk factors linked to the development of ischemic heart disease, systemic endothelial dysfunction could constitute a link between microcirculatory involvement in both organs: the heart and the brain. Additionally, the relation between chronic inflammatory status and microvascular disease in both the heart and the brain is not known.
The principal hypotheses and sub-hypotheses are as follows:
Principal hypotheses: 1. Patients with CMD have worse prognosis compared to those ones with normal coronary microcirculation. 2. Patients with CMD have a higher prevalence of CSVD. 3. Chronic systemic inflammation status is an independent predictor of CMD and CSVD.
Sub-hypotheses: 1. The presence of CMD is associated to recurrent/persistent angina. 2. The presence of CMD is associated to higher prevalence of depressive disorders. 3. CMD and CSVD are associated to systemic endothelial dysfunction.
Primary Objectives associated to Principal hypotheses: 1. To investigate the relationship between the presence of CMD and the development of patient-focused outcomes at 1 year of follow-up. 2. To determine the prevalence of CSVD in patients with CAD with and without CMD. 3. To investigate the relationship between systemic inflammation and CMD.
Primary Objectives associated to Sub-hypotheses: 1. To determine the prevalence of persistent or recurrent angina in patients with and without CMD in whom revascularization of CAD is guided by FFR. 2. To determine the prevalence of depressive disorders in patients with and without CMD. 3. To investigate the relationship between the status of systemic endothelial function and the presence of CMD and CSVD.
Methods: Patients with CAD undergoing FFR-guided revascularisation will be prospectively enrolled. FFR, coronary flow reserve (CFR) and the index of hyperemic microvascular resistance (HMR) will be measured with the Doppler guidewire (Combowire, Volcano - Philips corporation) under steady state hyperemia (intravenous adenosine infusion, 140 mcg/Kg/min). CMD will be defined according to CFR and HMR, and will be used to classify the overall population in two groups: the study group (presence of CMD) and the control group (absence of CMD). Coronary revascularization will be decided according to result of FFR (cutoff ≤0.80).
After the procedure the patient will undergo baseline clinical assessment: • Neurological clinical assessment and Transcranial Doppler Ultrasound. • Psychiatric clinical assessment. • Stress Cardiac MRI and Cerebral MRI. • Peripheral endothelial function test with plethysmography-based device EndoPat. • Laboratory blood tests for systemic inflammation markers, platelet function and endothelial progenitor cells. • Baseline assessment of angina status by the Seattle Questionnaire of angina (SAQ).
Clinical follow-up will be performed at 1-month, 6-months and 1-year, and will include: • clinical cardiology and psychiatric assessment, assessment of angina status by the SAQ. • stress test (1-year). • peripheral endothelial function test with plethysmography-based device EndoPat (1-year). • neurological clinical assessment and Transcranial Doppler Ultrasound (1- year). • laboratory blood tests for systemic inflammation markers, platelets function and endothelial progenitor cells(1-year).
Type of blinding: Data regarding coronary microcirculation invasive assessment, neurologic and psychiatric clinical assessment, cardiac and cerebral MRI, Trans-cranial Doppler Ultrasound, laboratory blood tests, systemic endothelial function and follow-up will be collected in a blinded fashion, so that patient and the other investigators, apart from the invasive cardiology team responsible for patient enrollment and study coordination, could not access to them. Primary events rate (major adverse cardiovascular events, incidence of CSVD, systemic inflammation status, depressive disorders, recurrent angina and systemic endothelial dysfunction) will be analyzed and correlated to CMD in a blinded fashion.
- Conditions
- Ischemic Heart Disease, Microvascular Coronary Artery Disease, Depression, Endothelial Dysfunction, Inflammation
- Being tested
- Coronary Angiography and Multimodal Coronary Physiology Study (FFR, CFR, HMR)
- Keywords
- Coronary microvascular dysfunction, Cerebral Small Vessel Diseases
- Medical subject headings
- Myocardial Ischemia, Depression, Inflammation, Cerebral Small Vessel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Angiography and Multimodal Coronary Physiology Study (FFR, CFR, HMR)Procedure or surgery
Coronary Angiography according to clinical indication and Multimodal Coronary Physiology Study (FFR, CFR, HMR) for functional assessment of intermediate coronary lesions
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients with CAD undergoing FFR-guided revascularisation. FFR, coronary flow reserve (CFR) and the index of hyperemic microvascular resistance (HMR) will be measured with the Doppler guidewire (Combowire, Volcano - Philips corporation) under steady state hyperemia. Receives: Procedure: Coronary Angiography and Multimodal Coronary Physiology Study (FFR, CFR, HMR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Major Cardiovascular Events (MACE): all-cause of death, myocardial infarction and any type of coronary revascularization
Clinical assessment
Measured: 1 month
Incidence of Major Cardiovascular Events (MACE): all-cause of death, myocardial infarction and any type of coronary revascularization
Clinical assessment.
Measured: 6 months
Incidence of Major Cardiovascular Events (MACE): all-cause of death, myocardial infarction and any type of coronary revascularization
Clinical assessment.
Measured: 1 year
Prevalence of Cerebral Small Vessel Disease (CSVD).
Determined by Cerebral MRI, transcranial Doppler Ultrasound and clinical assessment.
Measured: Baseline
Prevalence of Cerebral Small Vessel Disease (CSVD).
Determined by Cerebral MRI, transcranial Doppler Ultrasound and clinical assessment.
Measured: 1 year
Secondary outcomes (10)
Assessment of angina status by Seattle Angina Questionnaire (SAQ)
The SAQ (Seattle Angina Questionnaire) quantifies 5 domains measuring the impact of angina on patients' health status: Physical Limitation (9 items), Angina Stability (1 item), Angina Frequency (2 items), Treatment Satisfaction (4 items), and Quality of Life (3 items). Item responses are coded sequentially from worst to best status and range from 1 to 6 for Physical Limitation, Angina Stability, and Angina Frequency items; 1 to 5/6 for Treatment Satisfaction items; and 1 to 5 for Quality of Life items. Scores are generated for each domain and are scaled 0 to 100, with 0 denoting the worst and 100 the best possible status.
Measured: 1 month
Assessment of angina status by Seattle Angina Questionnaire (SAQ)
The SAQ (Seattle Angina Questionnaire) quantifies 5 domains measuring the impact of angina on patients' health status: Physical Limitation (9 items), Angina Stability (1 item), Angina Frequency (2 items), Treatment Satisfaction (4 items), and Quality of Life (3 items). Item responses are coded sequentially from worst to best status and range from 1 to 6 for Physical Limitation, Angina Stability, and Angina Frequency items; 1 to 5/6 for Treatment Satisfaction items; and 1 to 5 for Quality of Life items. Scores are generated for each domain and are scaled 0 to 100, with 0 denoting the worst and 100 the best possible status.
Measured: 6 months
Assessment of angina status by Seattle Angina Questionnaire (SAQ)
The SAQ (Seattle Angina Questionnaire) quantifies 5 domains measuring the impact of angina on patients' health status: Physical Limitation (9 items), Angina Stability (1 item), Angina Frequency (2 items), Treatment Satisfaction (4 items), and Quality of Life (3 items). Item responses are coded sequentially from worst to best status and range from 1 to 6 for Physical Limitation, Angina Stability, and Angina Frequency items; 1 to 5/6 for Treatment Satisfaction items; and 1 to 5 for Quality of Life items. Scores are generated for each domain and are scaled 0 to 100, with 0 denoting the worst and 100 the best possible status.
Measured: 1 year
Prevalence of depressive and anxiety disorders, determined by clinical assessment and dedicated questionnaires.
An expert psychologist will perform the following assessment: i) basal depression screening (Patient Health Questionnaire [PHQ-9]); ii) Standardized Interview (International neuropsychiatric interview) iii) evaluation of the severity of depression (Montgomery-Asberg score [MDRS]); iv) anxiety symptoms detection (Hamilton anxiety rating scale [HARS]); v) assessment of baseline quality of life (The MOS 36-item Short Form Health Survey [SF-36]); vi) functional skills assessment (The Lawton Instrumental Activities of Daily Living (IADL) Scale).
Measured: 1 month
Prevalence of depressive and anxiety disorders, determined by clinical assessment and dedicated questionnaires.
An expert psychologist will perform the following assessment: i) basal depression screening (Patient Health Questionnaire [PHQ-9]); ii) Standardized Interview (International neuropsychiatric interview) iii) evaluation of the severity of depression (Montgomery-Asberg score [MDRS]); iv) anxiety symptoms detection (Hamilton anxiety rating scale [HARS]); v) assessment of baseline quality of life (The MOS 36-item Short Form Health Survey [SF-36]); vi) functional skills assessment (The Lawton Instrumental Activities of Daily Living (IADL) Scale).
Measured: 6 months
Prevalence of depressive and anxiety disorders, determined by clinical assessment and dedicated questionnaires.
An expert psychologist will perform the following assessment: i) basal depression screening (Patient Health Questionnaire [PHQ-9]); ii) Standardized Interview (International neuropsychiatric interview) iii) evaluation of the severity of depression (Montgomery-Asberg score [MDRS]); iv) anxiety symptoms detection (Hamilton anxiety rating scale [HARS]); v) assessment of baseline quality of life (The MOS 36-item Short Form Health Survey [SF-36]); vi) functional skills assessment (The Lawton Instrumental Activities of Daily Living (IADL) Scale).
Measured: 1 year
Prevalence of systemic inflammation status, determined by laboratory blood tests.
Determination of blood levels of pro-inflammatory proteins (hsCRP, IL-1, IL-6, IL-18, VCAM-1 and ICAM-1) by ELISA method. Given the fact that the chronic inflammation can induce changes in the mononuclear cells phenotype, we will analyze the immune activation status (by analyzing CD4+/CD38+-T lymphocytes, CD8+/CD38+-T lymphocytes and CD8+/CD38+/HLADR+-T lymphocytes). The analysis will be performed by flow cytometry (Galios, Beckman Coulter). In addition, we will study the NRLP3 protein complex (which is involved in atherogenesis).
Measured: Baseline
Prevalence of systemic inflammation status, determined by laboratory blood tests.
Determination of blood levels of pro-inflammatory proteins (hsCRP, IL-1, IL-6, IL-18, VCAM-1 and ICAM-1) by ELISA method. Given the fact that the chronic inflammation can induce changes in the mononuclear cells phenotype, we will analyze the immune activation status (by analyzing CD4+/CD38+-T lymphocytes, CD8+/CD38+-T lymphocytes and CD8+/CD38+/HLADR+-T lymphocytes). The analysis will be performed by flow cytometry (Galios, Beckman Coulter). In addition, we will study the NRLP3 protein complex (which is involved in atherogenesis).
Measured: 1 year
Peripheral endothelial dysfunction, assessed by EndoPat.
Systemic endothelial dysfunction is defined as the inability of the arterial system to dilate appropriately in response to hyperaemia stimulus in order to increase blood flow according to metabolic demands. In this study, we will use the EndoPat technology that allows non-invasive evaluation of vasoreactivity by the assessment of the pulsatile arterial flow in the fingertip. We will assess changes in the flow from baseline and after inducing ischaemia by inflating a blood pressure cuff to occlude the brachial artery. Changes in endothelial measurements and in vascular tone after each occlusion of the brachial artery are a reflection of the hyperaemic vasoreactivity and endothelial function. By comparing the results during rest and ischaemia to the results obtained in the contralateral arm (which has not been subjected to ischaemia) we will obtain the index of reactive hyperaemia or EndoScore´. This Endoscore can then be used to evaluate endothelial function.
Measured: Baseline
Peripheral endothelial dysfunction, assessed by EndoPat.
Systemic endothelial dysfunction is defined as the inability of the arterial system to dilate appropriately in response to hyperaemia stimulus in order to increase blood flow according to metabolic demands. In this study, we will use the EndoPat technology that allows non-invasive evaluation of vasoreactivity by the assessment of the pulsatile arterial flow in the fingertip. We will assess changes in the flow from baseline and after inducing ischaemia by inflating a blood pressure cuff to occlude the brachial artery. Changes in endothelial measurements and in vascular tone after each occlusion of the brachial artery are a reflection of the hyperaemic vasoreactivity and endothelial function. By comparing the results during rest and ischaemia to the results obtained in the contralateral arm (which has not been subjected to ischaemia) we will obtain the index of reactive hyperaemia or EndoScore´. This Endoscore can then be used to evaluate endothelial function.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start1 Mar 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Mar 2020 (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 Ischemic Heart DiseaseStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Salud Carlos III
- Sponsor type
- Other government
- Collaborators
- Hospital San Carlos, Madrid
- Responsible party
- Principal investigator, Javier Escaned, Instituto de Salud Carlos III
- Investigators
- Javier Escaned, MD, PhD, Principal investigator, Instituto Carlos III. Hospital Clínico San Carlos.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131075
- Sponsor's protocol ID
- C3
- Acronym
- C3
- Status last verified
- Jan 2020
- First submitted
- 16 Oct 2019
- Last updated
- 6 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mejia-Renteria H, Travieso A, Matias-Guiu JA, Yus M, Espejo-Paeres C, Finocchiaro F, Fernandez S, Gomez-Escalonilla CI, Reneses-Prieto B, Gomez-Garre MD, Delgado-Alvarez A, Bustos A, Perez de Isla L, de Diego JJG, Modrego-Martin J, Ortega-Hernandez A, Papadopoulos P, Arrazola-Garcia J, Matias-Guiu J, Escaned J. Coronary microvascular dysfunction is associated with impaired cognitive function: the Cerebral-Coronary Connection study (C3 study). Eur Heart J. 2023 Jan 7;44(2):113-125. doi: 10.1093/eurheartj/ehac521.
PubMed 36337036
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microcirculatory Dysfunction in Stable Coronary Artery Disease: Relationship With Patient-focused Outcomes, Cerebral Small Vessel Disease and Depression.
- ClinicalTrials.gov ID
- NCT04131075
- Acronym / sponsor ID
- C3 / C3
- Conditions
- Ischemic Heart Disease, Microvascular Coronary Artery Disease, Depression, Endothelial Dysfunction, Inflammation
- Keywords
- Coronary microvascular dysfunction, Cerebral Small Vessel Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Instituto de Salud Carlos IIIOther government
- Collaborators
- Hospital San Carlos, Madrid
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 18 Oct 2019 (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.
This is a prospective cohort blinded study with the aim to investigate the prevalence and clinical impact of coronary microcirculatory dysfunction (CMD) in patients with ischemic heart disease, and its association with cerebral small vessel disease (CSVD) and depressive disorders. In addition, CMD and CSVD linkage to systemic inflammation and endothelial function will also be investigated.
Detailed description
The treatment of stable CAD is largely based on a paradigm that gives epicardial coronary stenoses a central role in the generation of myocardial ischaemia. However, coronary microcirculatory dysfunction (CMD) is a major and frequently ignored cause of ischaemia that, according to retrospective studies, influences the outcomes of patients with CAD. In addition, patients with CMD may not experience symptomatic relief with myocardial revascularization or pharmacological treatment. This constitutes one of the causes of persistent angina despite successful revascularization, causing not only an impairment of the quality of life and higher consumption of healthcare resources, but potentially affective disorders like depression, which has been found to be associated with CAD and with prognosis.
It also remains largely unknown whether CMD in stable CAD is organ-specific only or rather indicative of involvement of other vital organs. While this seems to be the case in the kidney and the retina, the relationship between CMD in the heart and the brain has not been studied. Beyond classical cardiovascular risk factors linked to the development of ischemic heart disease, systemic endothelial dysfunction could constitute a link between microcirculatory involvement in both organs: the heart and the brain. Additionally, the relation between chronic inflammatory status and microvascular disease in both the heart and the brain is not known.
The principal hypotheses and sub-hypotheses are as follows:
Principal hypotheses: 1. Patients with CMD have worse prognosis compared to those ones with normal coronary microcirculation. 2. Patients with CMD have a higher prevalence of CSVD. 3. Chronic systemic inflammation status is an independent predictor of CMD and CSVD.
Sub-hypotheses: 1. The presence of CMD is associated to recurrent/persistent angina. 2. The presence of CMD is associated to higher prevalence of depressive disorders. 3. CMD and CSVD are associated to systemic endothelial dysfunction.
Primary Objectives associated to Principal hypotheses: 1. To investigate the relationship between the presence of CMD and the development of patient-focused outcomes at 1 year of follow-up. 2. To determine the prevalence of CSVD in patients with CAD with and without CMD. 3. To investigate the relationship between systemic inflammation and CMD.
Primary Objectives associated to Sub-hypotheses: 1. To determine the prevalence of persistent or recurrent angina in patients with and without CMD in whom revascularization of CAD is guided by FFR. 2. To determine the prevalence of depressive disorders in patients with and without CMD. 3. To investigate the relationship between the status of systemic endothelial function and the presence of CMD and CSVD.
Methods: Patients with CAD undergoing FFR-guided revascularisation will be prospectively enrolled. FFR, coronary flow reserve (CFR) and the index of hyperemic microvascular resistance (HMR) will be measured with the Doppler guidewire (Combowire, Volcano - Philips corporation) under steady state hyperemia (intravenous adenosine infusion, 140 mcg/Kg/min). CMD will be defined according to CFR and HMR, and will be used to classify the overall population in two groups: the study group (presence of CMD) and the control group (absence of CMD). Coronary revascularization will be decided according to result of FFR (cutoff ≤0.80).
After the procedure the patient will undergo baseline clinical assessment: • Neurological clinical assessment and Transcranial Doppler Ultrasound. • Psychiatric clinical assessment. • Stress Cardiac MRI and Cerebral MRI. • Peripheral endothelial function test with plethysmography-based device EndoPat. • Laboratory blood tests for systemic inflammation markers, platelet function and endothelial progenitor cells. • Baseline assessment of angina status by the Seattle Questionnaire of angina (SAQ).
Clinical follow-up will be performed at 1-month, 6-months and 1-year, and will include: • clinical cardiology and psychiatric assessment, assessment of angina status by the SAQ. • stress test (1-year). • peripheral endothelial function test with plethysmography-based device EndoPat (1-year). • neurological clinical assessment and Transcranial Doppler Ultrasound (1- year). • laboratory blood tests for systemic inflammation markers, platelets function and endothelial progenitor cells(1-year).
Type of blinding: Data regarding coronary microcirculation invasive assessment, neurologic and psychiatric clinical assessment, cardiac and cerebral MRI, Trans-cranial Doppler Ultrasound, laboratory blood tests, systemic endothelial function and follow-up will be collected in a blinded fashion, so that patient and the other investigators, apart from the invasive cardiology team responsible for patient enrollment and study coordination, could not access to them. Primary events rate (major adverse cardiovascular events, incidence of CSVD, systemic inflammation status, depressive disorders, recurrent angina and systemic endothelial dysfunction) will be analyzed and correlated to CMD in a blinded fashion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Procedure: Coronary Angiography and Multimodal Coronary Physiology Study (FFR, CFR, HMR)Patients with CAD undergoing FFR-guided revascularisation. FFR, coronary flow reserve (CFR) and the index of hyperemic microvascular resistance (HMR) will be measured with the Doppler guidewire (Combowire, Volcano - Philips corporation) under steady state hyperemia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stable coronary lesions (stable coronary disease or lesions in non-culprit vessels >48 hours after acute coronary syndrome) with clinical indication to coronary angiography and intermediate coronary lesions (visual estimation) suitable for FFR-guided revascularization.
Key inclusion criteria (4 listed)
- Informed Consent available.
- Age ≥ 18 years.
- Stable coronary lesions.
- Indication to FFR: ≥ 1 intermediate coronary lesion (40-80% diameter stenosis) in a principal/secondary vessel with ≥ 2 mm reference diameter.
Key exclusion criteria (17 listed)
- Previous myocardial infarction in the territory of distribution of the target vessel.
- Coronary Left Main severe stenosis.
- Aortic valve stenosis (moderate or severe) .
- Severe left ventricle hypertrophy.
- Left ventricle moderate systolic dysfunction (EF < 35%).
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 Angiography and Multimodal Coronary Physiology Study (FFR, CFR, HMR)Coronary Angiography according to clinical indication and Multimodal Coronary Physiology Study (FFR, CFR, HMR) for functional assessment of intermediate coronary lesions | Procedure or surgery | Study group |
Primary outcome
Incidence of Major Cardiovascular Events (MACE): all-cause of death, myocardial infarction and any type of coronary revascularization
Time frame: 1 month
Clinical assessment
Incidence of Major Cardiovascular Events (MACE): all-cause of death, myocardial infarction and any type of coronary revascularization
Time frame: 6 months
Clinical assessment.
Incidence of Major Cardiovascular Events (MACE): all-cause of death, myocardial infarction and any type of coronary revascularization
Time frame: 1 year
Clinical assessment.
Prevalence of Cerebral Small Vessel Disease (CSVD).
Time frame: Baseline
Determined by Cerebral MRI, transcranial Doppler Ultrasound and clinical assessment.
Prevalence of Cerebral Small Vessel Disease (CSVD).
Time frame: 1 year
Determined by Cerebral MRI, transcranial Doppler Ultrasound and clinical assessment.
10 secondary outcomes
Assessment of angina status by Seattle Angina Questionnaire (SAQ)
Time frame: 1 month
Assessment of angina status by Seattle Angina Questionnaire (SAQ)
Time frame: 6 months
Assessment of angina status by Seattle Angina Questionnaire (SAQ)
Time frame: 1 year
Prevalence of depressive and anxiety disorders, determined by clinical assessment and dedicated questionnaires.
Time frame: 1 month
Prevalence of depressive and anxiety disorders, determined by clinical assessment and dedicated questionnaires.
Time frame: 6 months
Prevalence of depressive and anxiety disorders, determined by clinical assessment and dedicated questionnaires.
Time frame: 1 year
Prevalence of systemic inflammation status, determined by laboratory blood tests.
Time frame: Baseline
Prevalence of systemic inflammation status, determined by laboratory blood tests.
Time frame: 1 year
Peripheral endothelial dysfunction, assessed by EndoPat.
Time frame: Baseline
Peripheral endothelial dysfunction, assessed by EndoPat.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
- Derived from this study: PubMed 36337036Mejia-Renteria H, Travieso A, Matias-Guiu JA, Yus M, Espejo-Paeres C, Finocchiaro F, Fernandez S, Gomez-Escalonilla CI, Reneses-Prieto B, Gomez-Garre MD, Delgado-Alvarez A, Bustos A, Perez de Isla L, de Diego JJG, Modrego-Martin J, Ortega-Hernandez A, Papadopoulos P, Arrazola-Garcia J, Matias-Guiu J, Escaned J. Coronary microvascular dysfunction is associated with impaired cognitive function: the Cerebral-Coronary Connection study (C3 study). Eur Heart J. 2023 Jan 7;44(2):113-125. doi: 10.1093/eurheartj/ehac521.
- 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. This study is not recruiting at the moment.
Javier Escaned, MD, PhD principal investigator
Instituto Carlos III. Hospital Clínico San Carlos.
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 Ischemic Heart Disease and Microvascular Coronary Artery Disease, run by Instituto de Salud Carlos III 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 17 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 Jan 2020. 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 Hernan Mejia-Renteria, MD (+34/913303438, hmejiarenteria@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Major Cardiovascular Events (MACE): all-cause of death, myocardial infarction and any type of coronary revascularization (time frame: 1 month). The study lists 5 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 NCT04131075, 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 6 Jan 2020.