Acute Coronary SyndromeNCT04169516
Localization of Microvascular Dysfunction
An observational study of Acute Coronary Syndrome, run by Dong-A University.
Trial summary
Microvascular dysfunction is an independent predictor of poor prognosis. Such response in the culprit vessel is common even after successful revascularization. This study investigated whether the microvascular dysfunction differed between culprit and non-culprit vessels in patients with acute coronary syndrome (ACS)… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- index of microcirculatory resistance
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2014to 10 Nov 2019
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients with acute coronary syndrome
Who may be able to join
- Individuals were eligible for inclusion if they underwent PCI for ACS, if the target lesion was found in the proximal or middle segments of a major epicardial coronary artery, and if the lesion was successfully treated with a coronary stent.
Who cannot join
- a previous infarction other than in the vessel of interest or a history of coronary artery bypass surgery, cardiogenic shock requiring inotropic support, chronic kidney disease requiring renal replacement therapy, hypertrophic cardiomyopathy, collateral flow to the target vessel greater than angiographic grade 1, or statin or ticagrelor use within 1 year.
About this study
Official title: Different Microcirculation Response to Ischemic Injury of Culprit and Non-culprit
Microvascular dysfunction is an independent predictor of poor prognosis. Such response in the culprit vessel is common even after successful revascularization. This study investigated whether the microvascular dysfunction differed between culprit and non-culprit vessels in patients with acute coronary syndrome (ACS) who underwent percutaneous coronary intervention (PCI).
Read the detailed description
The prospective study included 115 patients with ACS. In this study, after successful PCI, culprit and non-culprit intracoronary hemodynamic measurements were performed and repeated at 6-month follow-up. 13N-ammonia positron emission tomography (PET) was performed at 6-month follow-up visit to determine absolute myocardial blood flow (MBF). The resistance values of each vessel were calculated using the coronary pressure data and the MBF values obtained from 13N-ammonia PET data. Such physiological measures were compared between culprit and non-culprit vessels in baseline and 6-month follow-up.
- Conditions
- Acute Coronary Syndrome
- Being tested
- index of microcirculatory resistance
- Keywords
- microcirculation
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
index of microcirculatory resistanceDiagnostic test
Also called 13N-ammonia positron emission tomography
Physiological parameters of the culprit artery after PCI were determined with the restoration of Thrombolysis in Myocardial Infarction (TIMI) 3 flow. Aortic pressure (Pa), distal intracoronary pressure (Pd), fractional flow reserve (FFR), coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) were measured using a 0.014 coronary temperature and pressure-sensing guidewire (PressureWireCertus, ST. Jude Medical, MN, USA).
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline index of microcirculatory resistance at 6 months
Physiological parameters of the culprit artery after PCI were determined with the restoration of Thrombolysis in Myocardial Infarction (TIMI) 3 flow. Index of microcirculatory resistance (IMR) were measured using a 0.014 coronary temperature and pressure-sensing guidewire (PressureWireCertus, ST. Jude Medical, MN, USA). These parameters were then determined for non-culprit vessels.
Measured: baseline and 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start1 Dec 2014
- Primary completion31 Dec 2015
- Study completion10 Nov 2019
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 Acute Coronary SyndromeStudies 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
- 115 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Dong-A University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyungil Park, Dong-A University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169516
- Sponsor's protocol ID
- 11-95
- Status last verified
- Nov 2019
- First submitted
- 14 Nov 2019
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jo YS, Moon H, Park K. Different Microcirculation Response Between Culprit and Non-Culprit Vessels in Patients With Acute Coronary Syndrome. J Am Heart Assoc. 2020 May 18;9(10):e015507. doi: 10.1161/JAHA.119.015507. Epub 2020 May 15.
PubMed 32410526
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Microcirculation Response to Ischemic Injury of Culprit and Non-culprit
- ClinicalTrials.gov ID
- NCT04169516
- Acronym / sponsor ID
- 11-95
- Conditions
- Acute Coronary Syndrome
- Keywords
- microcirculation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Dong-A UniversityUniversity, hospital or other
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 10 Nov 2019 (actual)
- First posted
- 20 Nov 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.
Microvascular dysfunction is an independent predictor of poor prognosis. Such response in the culprit vessel is common even after successful revascularization. This study investigated whether the microvascular dysfunction differed between culprit and non-culprit vessels in patients with acute coronary syndrome (ACS) who underwent percutaneous coronary intervention (PCI).
Detailed description
The prospective study included 115 patients with ACS. In this study, after successful PCI, culprit and non-culprit intracoronary hemodynamic measurements were performed and repeated at 6-month follow-up. 13N-ammonia positron emission tomography (PET) was performed at 6-month follow-up visit to determine absolute myocardial blood flow (MBF). The resistance values of each vessel were calculated using the coronary pressure data and the MBF values obtained from 13N-ammonia PET data. Such physiological measures were compared between culprit and non-culprit vessels in baseline and 6-month follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with acute coronary syndrome
Key inclusion criteria (1 listed)
- Individuals were eligible for inclusion if they underwent PCI for ACS, if the target lesion was found in the proximal or middle segments of a major epicardial coronary artery, and if the lesion was successfully treated with a coronary stent.
Key exclusion criteria (1 listed)
- a previous infarction other than in the vessel of interest or a history of coronary artery bypass surgery, cardiogenic shock requiring inotropic support, chronic kidney disease requiring renal replacement therapy, hypertrophic cardiomyopathy, collateral flow to the target vessel greater than angiographic grade 1, or statin or ticagrelor use within 1 year.
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 |
|---|---|---|
| index of microcirculatory resistanceAlso: 13N-ammonia positron emission tomographyPhysiological parameters of the culprit artery after PCI were determined with the restoration of Thrombolysis in Myocardial Infarction (TIMI) 3 flow. Aortic pressure (Pa), distal intracoronary pressure (Pd), fractional flow reserve (FFR), coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) were measured using a 0.014 coronary temperature and pressure-sensing guidewire (PressureWireCertus, ST. Jude Medical, MN, USA). | Diagnostic test | – |
Primary outcome
Change from Baseline index of microcirculatory resistance at 6 months
Time frame: baseline and 6-month
Physiological parameters of the culprit artery after PCI were determined with the restoration of Thrombolysis in Myocardial Infarction (TIMI) 3 flow. Index of microcirculatory resistance (IMR) were measured using a 0.014 coronary temperature and pressure-sensing guidewire (PressureWireCertus, ST. Jude Medical, MN, USA). These parameters were then determined for non-culprit vessels.
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 20 Nov 2019.
- Derived from this study: PubMed 32410526Jo YS, Moon H, Park K. Different Microcirculation Response Between Culprit and Non-Culprit Vessels in Patients With Acute Coronary Syndrome. J Am Heart Assoc. 2020 May 18;9(10):e015507. doi: 10.1161/JAHA.119.015507. Epub 2020 May 15.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by Dong-A University.
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 1 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 20 Nov 2019. 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?
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?
Change from Baseline index of microcirculatory resistance at 6 months (time frame: baseline and 6-month). 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 NCT04169516, 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 20 Nov 2019.