Coronary Artery DiseaseCIMANCT02332564
Coronary Steal Via Natural Internal Mammary Artery-To-Coronary Artery Bypasses
An observational study of Coronary Artery Disease and Ischemia, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
CORONARY ARTERY DISEASE AND THE BENEFIT OF BYPASSES Despite considerable advances in medicine, cardiovascular diseases remain the number one cause of death globally. In industrialized countries, coronary artery disease (CAD) is the leading cause of death, consequence of myocardial infarction (MI). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Ischemia
- What is being tested?
- Coronary Artery Balloon Occlusion for Determination of Collateral Flow Index
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2014to Jul 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients electively referred for coronary angiography
Who may be able to join
- Age > 18 years
- Referred for elective coronary angiography
- Written informed consent to participate in the study
Who cannot join
- Acute coronary syndrome; unstable cardiopulmonary conditions
- Severe cardiac valve disease
- Congestive heart failure NYHA III-IV
- Prior coronary artery bypass surgery / prior cardiac surgery
- Coronary artery disease unsuitable for intracoronary pressure measurements
- Prior Q-wave myocardial infarction in the vascular territory undergoing collateral function determination
- Severe renal or hepatic failure
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
CORONARY ARTERY DISEASE AND THE BENEFIT OF BYPASSES
Despite considerable advances in medicine, cardiovascular diseases remain the number one cause of death globally. In industrialized countries, coronary artery disease (CAD) is the leading cause of death, consequence of myocardial infarction (MI). Artificial - or natural - bypasses exert a protective effect by providing an alternative source of blood flow to a myocardial territory potentially affected by an acute coronary occlusion. Coronary collaterals represent pre-existing inter-arterial anastomoses and as such are the natural counter-part of surgically created bypasses. In patients with chronic CAD, sufficient coronary collaterals have been shown to confer a significant benefits in terms of overall mortality and cardiovascular events.
Read more
EXTRACARDIAC-TO-CORONARY COLLATERAL SUPPLY
Commonly, coronary collaterals are implicitly understood to exist between coronary artery branches. However, the structural existence of coronary collaterals with an extracardiac connection has been confirmed by anatomical investigations. Pathophysiologically and with regard to a potential for arteriogenic stimulation, the connections from the internal mammary arteries, are of special interest.
In a recently published work the investigators have investigated the effect of temporary balloon occlusion of the distal IMA on coronary collateral function. There were equivocal findings for the left circumflex coronary artery: CFI was increased by ipsilateral IMA occlusion, but the level of myocardial ischemia was unchanged.
MYOCARDIAL STEAL VIA INTERNAL MAMMARY ARTERIES
In the investigators' previous study, the coronary occlusion with simultaneous distal IMA occlusion was always performed first as a conservative measure against false-positive detection of internal-mammary-to-coronary artery connections. Repetitive coronary occlusions per se result in higher collateral flow by collateral recruitment and reduced ischemia by ischemic preconditioning and augmented collateral function. Conversely, the sensitivity of the employed method was reduced and might have contributed to the equivocal findings in case of the left circumflex artery. Moreover, the hypothesize d mechanism of localized pressure augmentation was not investigated.
This study aims to further characterize the prevalence and function of natural ipsilateral IMA-to-coronary connections, as well as to investigate the hemodynamic mechanisms of coronary collateral function augmentation by distal IMA occlusion. In the investigators' last study, the increased coronary collateral function in response to manipulation of a potential coronary collateral donor (in this case, the IMA) was taken as indirect evidence for the existence of IMA-to-coronary-artery connections. Thus, the employed distal IMA occlusion served as a positive stimulus. Conceptually, additional evaluation with a negative stimulus could heighten the discriminatory power of the investigation. This could be in the form of a hyperemic stimulus affecting the collateral donor, ie in analogy to myocardial or coronary steal (ie, a reduction in coronary collateral supply to a collateral recipient).
Read the detailed description
CORONARY ARTERY DISEASE AND THE BENEFIT OF BYPASSES
Despite considerable advances in medicine, cardiovascular diseases remain the number one cause of death globally. In industrialized countries, coronary artery disease (CAD) is the leading cause of death, consequence of myocardial infarction (MI).
In patients with acute coronary syndrome, percutaneous coronary intervention (PCI) has been shown to improve outcomes.2 However, in stable CAD, PCI has not been demonstrated to reduce the incidence of myocardial infarction or death. Coronary artery bypass grafting (CABG) was superior to PCI in patients with diabetes and multivessel coronary artery disease. CABG significantly reduced rates of death and myocardial infarction compared to PCI, but with a higher rate of stroke. Furthermore, in patients with advanced coronary artery disease, rates of myocardial infarction were more than 60% lower with CABG compared to PCI.
Conceptually, the benefit of CABG over PCI is not surprising as PCI targets significant coronary lesions thought to be responsible for causing ischemia. However, the deleterious effects of atherosclerosis are not typically preceded by significant luminal vascular narrowing. The vulnerable plaque eventually becoming the culprit plaque (causing myocardial infarction or sudden cardiac death) is typically relatively nonstenotic. Furthermore, due to being multifocal and widespread, plaque vulnerability is not a target for, nor amenable to PCI.
Conversely, artificial - or natural - bypasses exert a protective effect by providing an alternative source of blood flow to a myocardial territory potentially affected by an acute coronary occlusion. Coronary collaterals represent pre-existing inter-arterial anastomoses and as such are the natural counter-part of surgically created bypasses. In patients with chronic CAD, sufficient coronary collaterals have been shown to confer a significant benefits in terms of overall mortality and cardiovascular events.
EXTRACARDIAC-TO-CORONARY COLLATERAL SUPPLY
Commonly, coronary collaterals are implicitly understood to exist between coronary artery branches. However, the structural existence of coronary collaterals with an extracardiac connection has been confirmed by anatomical investigations. Pathophysiologically and with regard to a potential for arteriogenic stimulation, the connections from the internal mammary arteries, are of special interest. Indeed, before the advent of coronary bypass surgery, several clinical studies examined the usefulness of a minimally invasive surgery to augment collateral flow to the heart via these internal-mammary-to-coronary-artery connections in patients with angina pectoris. The performed distal bilateral ligation of the internal mammary arteries was thought to improve flow over naturally pre-existing anastomoses between the internal mammary arteries and the coronary circulation.
In a recently published work the investigators have investigated the effect of temporary balloon occlusion of the distal IMA on coronary collateral function. 180 pairs of measurements were performed in 120 patients electively referred for coronary angiography. Levels of collateral function and myocardial ischemia were determined during two coronary balloon occlusions, the first with, the second without distal IMA balloon occlusion. Coronary collateral function, determined by collateral flow index (CFI) was consistently increased by ipsilateral, but not contralateral IMA balloon occlusion in the left anterior descending (LAD) coronary artery and the right coronary artery (RCA). Furthermore, these findings were corroborated by the observed reduction in ischemia as assessed by the sensitive tool of intracoronary ECG. However, there were equivocal findings for the left circumflex coronary artery: CFI was increased by ipsilateral IMA occlusion, but the level of myocardial ischemia was unchanged.
MYOCARDIAL STEAL VIA INTERNAL MAMMARY ARTERIES
In the investigators' previous study, the coronary occlusion with simultaneous distal IMA occlusion was always performed first as a conservative measure against false-positive detection of internal-mammary-to-coronary artery connections. Repetitive coronary occlusions per se result in higher collateral flow by collateral recruitment and reduced ischemia by ischemic preconditioning and augmented collateral function. Conversely, the sensitivity of the employed method was reduced and might have contributed to the equivocal findings in case of the left circumflex artery. Moreover, the hypothesize d mechanism of localized pressure augmentation was not investigated.
This study aims to further characterize the prevalence and function of natural ipsilateral IMA-to-coronary connections, as well as to investigate the hemodynamic mechanisms of coronary collateral function augmentation by distal IMA occlusion. In the investigators' last study, the increased coronary collateral function in response to manipulation of a potential coronary collateral donor (in this case, the IMA) was taken as indirect evidence for the existence of IMA-to-coronary-artery connections. Thus, the employed distal IMA occlusion served as a positive stimulus. Conceptually, additional evaluation with a negative stimulus could heighten the discriminatory power of the investigation. This could be in the form of a hyperemic stimulus affecting the collateral donor, ie in analogy to myocardial or coronary steal (ie, a reduction in coronary collateral supply to a collateral recipient).
- Conditions
- Coronary Artery Disease, Ischemia
- Being tested
- Coronary Artery Balloon Occlusion for Determination of Collateral Flow Index
- Keywords
- Circulation, Collateral, Coronary Artery Disease, Internal Mammary-Coronary Artery Anastomosis, Ischemia
- Medical subject headings
- Coronary Artery Disease, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Artery Balloon Occlusion for Determination of Collateral Flow IndexOther
Coronary Artery Balloon Occlusion for Determination of Collateral Flow Index
| Study group | Role | What they receive |
|---|---|---|
| Coronary Artery Disease | Patient with significant coronary artery disease Receives: Other: Coronary Artery Balloon Occlusion for Determination of Collateral Flow Index | |
| No Coronary Artery Disease | Patient without significant coronary artery disease Receives: Other: Coronary Artery Balloon Occlusion for Determination of Collateral Flow Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary collateral function (CFI)
Coronary collateral function (CFI)
Measured: Baseline
Secondary outcomes (3)
Myocardial ischemia during temporary coronary balloon occlusion
Measured: Baseline
Proximal IMA pressure immediately before and during (ipsilateral) reactive arm hyperemia.
Measured: Baseline
Distal IMA CFI
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionNov 2020
- Study completionJul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Seiler, MD, Prof., Principal investigator, Department of Cardiology, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332564
- Sponsor's protocol ID
- SNCTP000001138
- Other IDs
- 2631
- Acronym
- CIMA
- Status last verified
- Feb 2023
- First submitted
- 5 Jan 2015
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Stoller M, de Marchi SF, Seiler C. Function of natural internal mammary-to-coronary artery bypasses and its effect on myocardial ischemia. Circulation. 2014 Jun 24;129(25):2645-52. doi: 10.1161/CIRCULATIONAHA.114.008898. Epub 2014 Apr 17.
PubMed 24744276BLAIR CR, ROTH RF, ZINTEL HA. Measurement of coronary artery blood-flow following experimental ligation of the internal mammary artery. Ann Surg. 1960 Aug;152(2):325-9. doi: 10.1097/00000658-196008000-00018. No abstract available.
PubMed 13801236Bigler MR, Buffle E, Stoller M, Grossenbacher R, Tschannen C, Seiler C. Extracardiac coronary steal induced by upper limb hyperemia: a feature of internal mammary artery arteriogenesis. J Appl Physiol (1985). 2021 Sep 1;131(3):905-913. doi: 10.1152/japplphysiol.00082.2021. Epub 2021 Jul 8.
PubMed 34236245
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Steal Via Natural Internal Mammary Artery-To-Coronary Artery Bypasses
- ClinicalTrials.gov ID
- NCT02332564
- Acronym / sponsor ID
- CIMA / SNCTP000001138
- Conditions
- Coronary Artery Disease, Ischemia
- Keywords
- Circulation, Collateral, Coronary Artery Disease, Internal Mammary-Coronary Artery Anastomosis, Ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Nov 2020 (actual)
- Study completion
- Jul 2021 (actual)
- First posted
- 7 Jan 2015 (estimated)
- 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.
CORONARY ARTERY DISEASE AND THE BENEFIT OF BYPASSES
Despite considerable advances in medicine, cardiovascular diseases remain the number one cause of death globally. In industrialized countries, coronary artery disease (CAD) is the leading cause of death, consequence of myocardial infarction (MI). Artificial - or natural - bypasses exert a protective effect by providing an alternative source of blood flow to a myocardial territory potentially affected by an acute coronary occlusion. Coronary collaterals represent pre-existing inter-arterial anastomoses and as such are the natural counter-part of surgically created bypasses. In patients with chronic CAD, sufficient coronary collaterals have been shown to confer a significant benefits in terms of overall mortality and cardiovascular events.
EXTRACARDIAC-TO-CORONARY COLLATERAL SUPPLY
Commonly, coronary collaterals are implicitly understood to exist between coronary artery branches. However, the structural existence of coronary collaterals with an extracardiac connection has been confirmed by anatomical investigations. Pathophysiologically and with regard to a potential for arteriogenic stimulation, the connections from the internal mammary arteries, are of special interest.
In a recently published work the investigators have investigated the effect of temporary balloon occlusion of the distal IMA on coronary collateral function. There were equivocal findings for the left circumflex coronary artery: CFI was increased by ipsilateral IMA occlusion, but the level of myocardial ischemia was unchanged.
MYOCARDIAL STEAL VIA INTERNAL MAMMARY ARTERIES
In the investigators' previous study, the coronary occlusion with simultaneous distal IMA occlusion was always performed first as a conservative measure against false-positive detection of internal-mammary-to-coronary artery connections. Repetitive coronary occlusions per se result in higher collateral flow by collateral recruitment and reduced ischemia by ischemic preconditioning and augmented collateral function. Conversely, the sensitivity of the employed method was reduced and might have contributed to the equivocal findings in case of the left circumflex artery. Moreover, the hypothesize d mechanism of localized pressure augmentation was not investigated.
This study aims to further characterize the prevalence and function of natural ipsilateral IMA-to-coronary connections, as well as to investigate the hemodynamic mechanisms of coronary collateral function augmentation by distal IMA occlusion. In the investigators' last study, the increased coronary collateral function in response to manipulation of a potential coronary collateral donor (in this case, the IMA) was taken as indirect evidence for the existence of IMA-to-coronary-artery connections. Thus, the employed distal IMA occlusion served as a positive stimulus. Conceptually, additional evaluation with a negative stimulus could heighten the discriminatory power of the investigation. This could be in the form of a hyperemic stimulus affecting the collateral donor, ie in analogy to myocardial or coronary steal (ie, a reduction in coronary collateral supply to a collateral recipient).
Detailed description
CORONARY ARTERY DISEASE AND THE BENEFIT OF BYPASSES
Despite considerable advances in medicine, cardiovascular diseases remain the number one cause of death globally. In industrialized countries, coronary artery disease (CAD) is the leading cause of death, consequence of myocardial infarction (MI).
In patients with acute coronary syndrome, percutaneous coronary intervention (PCI) has been shown to improve outcomes.2 However, in stable CAD, PCI has not been demonstrated to reduce the incidence of myocardial infarction or death. Coronary artery bypass grafting (CABG) was superior to PCI in patients with diabetes and multivessel coronary artery disease. CABG significantly reduced rates of death and myocardial infarction compared to PCI, but with a higher rate of stroke. Furthermore, in patients with advanced coronary artery disease, rates of myocardial infarction were more than 60% lower with CABG compared to PCI.
Conceptually, the benefit of CABG over PCI is not surprising as PCI targets significant coronary lesions thought to be responsible for causing ischemia. However, the deleterious effects of atherosclerosis are not typically preceded by significant luminal vascular narrowing. The vulnerable plaque eventually becoming the culprit plaque (causing myocardial infarction or sudden cardiac death) is typically relatively nonstenotic. Furthermore, due to being multifocal and widespread, plaque vulnerability is not a target for, nor amenable to PCI.
Conversely, artificial - or natural - bypasses exert a protective effect by providing an alternative source of blood flow to a myocardial territory potentially affected by an acute coronary occlusion. Coronary collaterals represent pre-existing inter-arterial anastomoses and as such are the natural counter-part of surgically created bypasses. In patients with chronic CAD, sufficient coronary collaterals have been shown to confer a significant benefits in terms of overall mortality and cardiovascular events.
EXTRACARDIAC-TO-CORONARY COLLATERAL SUPPLY
Commonly, coronary collaterals are implicitly understood to exist between coronary artery branches. However, the structural existence of coronary collaterals with an extracardiac connection has been confirmed by anatomical investigations. Pathophysiologically and with regard to a potential for arteriogenic stimulation, the connections from the internal mammary arteries, are of special interest. Indeed, before the advent of coronary bypass surgery, several clinical studies examined the usefulness of a minimally invasive surgery to augment collateral flow to the heart via these internal-mammary-to-coronary-artery connections in patients with angina pectoris. The performed distal bilateral ligation of the internal mammary arteries was thought to improve flow over naturally pre-existing anastomoses between the internal mammary arteries and the coronary circulation.
In a recently published work the investigators have investigated the effect of temporary balloon occlusion of the distal IMA on coronary collateral function. 180 pairs of measurements were performed in 120 patients electively referred for coronary angiography. Levels of collateral function and myocardial ischemia were determined during two coronary balloon occlusions, the first with, the second without distal IMA balloon occlusion. Coronary collateral function, determined by collateral flow index (CFI) was consistently increased by ipsilateral, but not contralateral IMA balloon occlusion in the left anterior descending (LAD) coronary artery and the right coronary artery (RCA). Furthermore, these findings were corroborated by the observed reduction in ischemia as assessed by the sensitive tool of intracoronary ECG. However, there were equivocal findings for the left circumflex coronary artery: CFI was increased by ipsilateral IMA occlusion, but the level of myocardial ischemia was unchanged.
MYOCARDIAL STEAL VIA INTERNAL MAMMARY ARTERIES
In the investigators' previous study, the coronary occlusion with simultaneous distal IMA occlusion was always performed first as a conservative measure against false-positive detection of internal-mammary-to-coronary artery connections. Repetitive coronary occlusions per se result in higher collateral flow by collateral recruitment and reduced ischemia by ischemic preconditioning and augmented collateral function. Conversely, the sensitivity of the employed method was reduced and might have contributed to the equivocal findings in case of the left circumflex artery. Moreover, the hypothesize d mechanism of localized pressure augmentation was not investigated.
This study aims to further characterize the prevalence and function of natural ipsilateral IMA-to-coronary connections, as well as to investigate the hemodynamic mechanisms of coronary collateral function augmentation by distal IMA occlusion. In the investigators' last study, the increased coronary collateral function in response to manipulation of a potential coronary collateral donor (in this case, the IMA) was taken as indirect evidence for the existence of IMA-to-coronary-artery connections. Thus, the employed distal IMA occlusion served as a positive stimulus. Conceptually, additional evaluation with a negative stimulus could heighten the discriminatory power of the investigation. This could be in the form of a hyperemic stimulus affecting the collateral donor, ie in analogy to myocardial or coronary steal (ie, a reduction in coronary collateral supply to a collateral recipient).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coronary Artery Disease | – | Other: Coronary Artery Balloon Occlusion for Determination of Collateral Flow IndexPatient with significant coronary artery disease |
| No Coronary Artery Disease | – | Other: Coronary Artery Balloon Occlusion for Determination of Collateral Flow IndexPatient without significant coronary artery disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients electively referred for coronary angiography
Key inclusion criteria (3 listed)
- Age > 18 years
- Referred for elective coronary angiography
- Written informed consent to participate in the study
Key exclusion criteria (8 listed)
- Acute coronary syndrome; unstable cardiopulmonary conditions
- Severe cardiac valve disease
- Congestive heart failure NYHA III-IV
- Prior coronary artery bypass surgery / prior cardiac surgery
- Coronary artery disease unsuitable for intracoronary pressure measurements
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 Artery Balloon Occlusion for Determination of Collateral Flow IndexCoronary Artery Balloon Occlusion for Determination of Collateral Flow Index | Other | Coronary Artery Disease, No Coronary Artery Disease |
Primary outcome
Coronary collateral function (CFI)
Time frame: Baseline
Coronary collateral function (CFI)
3 secondary outcomes
Myocardial ischemia during temporary coronary balloon occlusion
Time frame: Baseline
Proximal IMA pressure immediately before and during (ipsilateral) reactive arm hyperemia.
Time frame: Baseline
Distal IMA CFI
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Background: PubMed 24744276Stoller M, de Marchi SF, Seiler C. Function of natural internal mammary-to-coronary artery bypasses and its effect on myocardial ischemia. Circulation. 2014 Jun 24;129(25):2645-52. doi: 10.1161/CIRCULATIONAHA.114.008898. Epub 2014 Apr 17.
- Background: PubMed 13801236BLAIR CR, ROTH RF, ZINTEL HA. Measurement of coronary artery blood-flow following experimental ligation of the internal mammary artery. Ann Surg. 1960 Aug;152(2):325-9. doi: 10.1097/00000658-196008000-00018. No abstract available.
- Background: PubMed 34236245Bigler MR, Buffle E, Stoller M, Grossenbacher R, Tschannen C, Seiler C. Extracardiac coronary steal induced by upper limb hyperemia: a feature of internal mammary artery arteriogenesis. J Appl Physiol (1985). 2021 Sep 1;131(3):905-913. doi: 10.1152/japplphysiol.00082.2021. Epub 2021 Jul 8.
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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.
Christian Seiler, MD, Prof. principal investigator
Department of Cardiology, Bern University Hospital
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 Coronary Artery Disease and Ischemia, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 14 Feb 2023. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Coronary collateral function (CFI) (time frame: Baseline). 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 NCT02332564, which also lists 3 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 14 Feb 2023.