Coronary Slow FlowPECSNCT02650557
Prediction Value of Ecg on Coronary Slow-flow
An observational study of Coronary Slow Flow, run by Sun Yat-sen University at 1 site in China.
Trial summary
The investigators aimed to investigate the vessel heterogeneity of Thrombolysis in Myocardial Infarction frame count (TFC) in the three coronary arteries, and its relation to P-wave dispersion, in patients with coronary slow flow and otherwise normal coronary arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Slow Flow
- What is being tested?
- angiography
- Type of treatment
- Surgery or procedure
- How many people
- 998 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Oct 2015
- 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: All of the subjects had chest pain and were referred to our catheterization laboratory for coronary angiography. Diagnosis of CSF was based on thrombolysis in myocardial infarction (TIMI) frame count (TFC).
Who may be able to join
- All of the subjects had chest pain and were referred to our catheterization laboratory for coronary angiography
Who cannot join
- Valvular or congenital heart disease
- Atrial fibrillation or other arrhythmia that would interfere with ECG analysis
- Left ventricular hypertrophy
- Myocardial or pericardial disease
- Chronic obstructive pulmonary disease, or electrolyte abnormalities.
- Subjects taking antiarrhythmic, antiischemic, β-blocker, or calcium-channel blocker medications were also excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction Value of Ecg on Coronary Slow-flow (PECS) Study
The investigators aimed to investigate the vessel heterogeneity of Thrombolysis in Myocardial Infarction frame count (TFC) in the three coronary arteries, and its relation to P-wave dispersion, in patients with coronary slow flow and otherwise normal coronary arteries.
Read the detailed description
Coronary slow flow (CSF) phenomenon, which is characterized by delayed coronary opacification in the absence of obstructive epicardial coronary artery disease, is a relatively common finding in patients undergoing routine coronary angiography and is often associated with chest pain. In some patients with CSF, blood flow may be heterogeneously distributed in the three coronary arteries, suggesting the heterogeneously distributed microvascular dysfunction in the myocardium. However, the vessel heterogeneity of Thrombolysis in Myocardial Infarction (TIMI) frame count (TFC) has not been fully elucidated.
P-wave dispersion (PWD) is defined as the difference between the longest and the shortest P-wave duration recorded from multiple different surface electrocardiogram (ECG) leads, and it has been reported to be associated with inhomogeneous and discontinuous propagation of sinus impulses5, which are well known electrophysiologic characteristics of the atrium prone to fibrillation. Although it is plausible to hypothesize that PWD might be associated with the heterogeneously distributed microvascular dysfunction, and previous studies have demonstrated the abnormal PWD in patients with CSF, the correlation between TFC heterogeneity and PWD has never been evaluated.
In this study, the investigators aimed to investigate the vessel heterogeneity of TFC in the three coronary arteries, and its relation to PWD, in patients with CSF and otherwise normal coronary arteries.
- Conditions
- Coronary Slow Flow
- Being tested
- angiography
- Keywords
- coronary slow flow, P-wave dispersion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
angiographyProcedure or surgery
angiography or arteriography is a medical imaging technique used to visualize the inside, or lumen, of blood vessels and organs of the body, with particular interest in the arteries, veins, and the heart chambers. This is traditionally done by injecting a radio-opaque contrast agent into the blood vessel and imaging using X-ray based techniques such as fluoroscopy.
| Study group | Role | What they receive |
|---|---|---|
| CSF group | consecutive patients with angiographically documented CSF Receives: Procedure: angiography | |
| control group | age- and gender-matched control subjects Receives: Procedure: angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average thrombolysis in myocardial infarction (TIMI) frame count (TFC) in the three coronary arteries and its relation to P waves parameters on ECG in patients with CSF and otherwise normal coronary arteries
The first frame was defined as the frame in which concentrated dye occupies the full width of the proximal coronary artery lumen, touching both borders of the lumen, and indicates forward motion down the artery. The final frame counted is that in which the contrast first reaches the distal predefined landmark branch without the necessity for full opacification. The difference between maximum and minimum P wave duration (Pmax and Pmin) was calculated from the 12-lead ECG and defined as PWD.
Measured: 24-72 hours
Secondary outcomes (1)
maximum and minimum P wave duration (Pmax and Pmin) and major adverse cardiac events (MACE) in patients with CSF and otherwise normal coronary arteries
The occurrence of major adverse cardiac events, defined as (1) death, (2) nonfatal myocardial infarction, or (3) target vessel revascularization. Myocardial infarction was diagnosed by a rise in the creatine kinase level to more than twice the upper normal limit with an increased creatine kinase-MB. Target lesion revascularization was defined as a repeat intervention (surgical or percutaneous) to treat a luminal stenosis within the stent or in the 5-mm distal or proximal segments adjacent to the stent. Target vessel revascularization was defined as a reintervention driven by any lesion located in the same epicardial vessel. Thrombotic stent occlusion was angiographically documented as a complete occlusion (TIMI flow 0 or 1) or a flow-limiting thrombus (TIMI flow 1 or 2) of a previously successfully treated artery.
Measured: 24 hours-30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study startJan 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Slow FlowStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 998 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao-dong Zhuang, Sun Yat-sen University
- Investigators
- zhimin du, MD, Principal investigator, fitst affiliated hospital of SYSU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02650557
- Sponsor's protocol ID
- PECS-sysu
- Acronym
- PECS
- Status last verified
- Jan 2016
- First submitted
- 3 Jan 2016
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction Value of Ecg on Coronary Slow-flow (PECS) Study
- ClinicalTrials.gov ID
- NCT02650557
- Acronym / sponsor ID
- PECS / PECS-sysu
- Conditions
- Coronary Slow Flow
- Keywords
- coronary slow flow, P-wave dispersion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 998 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 8 Jan 2016 (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.
The investigators aimed to investigate the vessel heterogeneity of Thrombolysis in Myocardial Infarction frame count (TFC) in the three coronary arteries, and its relation to P-wave dispersion, in patients with coronary slow flow and otherwise normal coronary arteries.
Detailed description
Coronary slow flow (CSF) phenomenon, which is characterized by delayed coronary opacification in the absence of obstructive epicardial coronary artery disease, is a relatively common finding in patients undergoing routine coronary angiography and is often associated with chest pain. In some patients with CSF, blood flow may be heterogeneously distributed in the three coronary arteries, suggesting the heterogeneously distributed microvascular dysfunction in the myocardium. However, the vessel heterogeneity of Thrombolysis in Myocardial Infarction (TIMI) frame count (TFC) has not been fully elucidated.
P-wave dispersion (PWD) is defined as the difference between the longest and the shortest P-wave duration recorded from multiple different surface electrocardiogram (ECG) leads, and it has been reported to be associated with inhomogeneous and discontinuous propagation of sinus impulses5, which are well known electrophysiologic characteristics of the atrium prone to fibrillation. Although it is plausible to hypothesize that PWD might be associated with the heterogeneously distributed microvascular dysfunction, and previous studies have demonstrated the abnormal PWD in patients with CSF, the correlation between TFC heterogeneity and PWD has never been evaluated.
In this study, the investigators aimed to investigate the vessel heterogeneity of TFC in the three coronary arteries, and its relation to PWD, in patients with CSF and otherwise normal coronary arteries.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSF group | – | Procedure: angiographyconsecutive patients with angiographically documented CSF |
| control group | – | Procedure: angiographyage- and gender-matched control subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All of the subjects had chest pain and were referred to our catheterization laboratory for coronary angiography. Diagnosis of CSF was based on thrombolysis in myocardial infarction (TIMI) frame count (TFC).
Key inclusion criteria (1 listed)
- All of the subjects had chest pain and were referred to our catheterization laboratory for coronary angiography
Key exclusion criteria (6 listed)
- Valvular or congenital heart disease
- Atrial fibrillation or other arrhythmia that would interfere with ECG analysis
- Left ventricular hypertrophy
- Myocardial or pericardial disease
- Chronic obstructive pulmonary disease, or electrolyte abnormalities.
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 |
|---|---|---|
| angiographyangiography or arteriography is a medical imaging technique used to visualize the inside, or lumen, of blood vessels and organs of the body, with particular interest in the arteries, veins, and the heart chambers. This is traditionally done by injecting a radio-opaque contrast agent into the blood vessel and imaging using X-ray based techniques such as fluoroscopy. | Procedure or surgery | CSF group, control group |
Primary outcome
Average thrombolysis in myocardial infarction (TIMI) frame count (TFC) in the three coronary arteries and its relation to P waves parameters on ECG in patients with CSF and otherwise normal coronary arteries
Time frame: 24-72 hours
The first frame was defined as the frame in which concentrated dye occupies the full width of the proximal coronary artery lumen, touching both borders of the lumen, and indicates forward motion down the artery. The final frame counted is that in which the contrast first reaches the distal predefined landmark branch without the necessity for full opacification. The difference between maximum and minimum P wave duration (Pmax and Pmin) was calculated from the 12-lead ECG and defined as PWD.
1 secondary outcome
maximum and minimum P wave duration (Pmax and Pmin) and major adverse cardiac events (MACE) in patients with CSF and otherwise normal coronary arteries
Time frame: 24 hours-30 days
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 8 Jan 2016.
- 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.
zhimin du, MD principal investigator
fitst affiliated hospital of SYSU
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 Slow Flow, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2016. 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 China. 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?
Average thrombolysis in myocardial infarction (TIMI) frame count (TFC) in the three coronary arteries and its relation to P waves parameters on ECG in patients with CSF and otherwise normal coronary arteries (time frame: 24-72 hours). 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 8 Jan 2016.