Right Coronary Artery OcclusionNCT03543345
Right Ventricular Function Change After PCI to Right Coronary Artery
An observational study of Right Coronary Artery Occlusion, run by Assiut University at 1 site in Egypt.
Trial summary
Proximal RCA occlusions were very often found among men with fatal pre-hospital MI; whereas left-sided coronary occlusions were significantly more frequent in hospital-admitted survivors of MI. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Right Coronary Artery Occlusion
- What is being tested?
- echocardiography study
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2018to 28 Aug 2018
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients subjected to elective PCI due to right coronary artery occlusion. Patients between 40 and 75 years old from the both genders
Who may be able to join
- Patients subjected to elective PCI due to right coronary artery occlusion. Patients between 40 and 75 years old from the both genders
Who cannot join
- History of chronic respiratory condition and PHTN
- Patients with previous percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG).
- History of valvular surgery.
- Patients with significant rheumatic vavular heart disease.
- Presence of persistant arrythemia
- Patients with End stage renal disease.
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- Patients with End stage liver disease.
- Haemodynamically unstable patients.
- Patients with previous Myocardial infarction.
- Patients with Ischemic Dilated Cardiomyopathy.
- Patients with pericardial disease.
- Patients with congenital intra-cardiac shunt.
Trial locations and contacts
1 site in 1 country.
Mahmoud A. Abd Elbaset, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Al Azhar university
Asyut
Hazim alaa, +201118186565, ihazim1990@gmail.com
About this study
Official title: The Changes in The Right Ventricular Function After Elective Percutaneous Coronary Intervention in Patients With Right Coronary Artery Occlusion
Proximal RCA occlusions were very often found among men with fatal pre-hospital MI; whereas left-sided coronary occlusions were significantly more frequent in hospital-admitted survivors of MI. Left-sided coronary occlusions may be associated with a more favorable pre-hospital phase of acute MI compared to proximal RCA occlusions. Proximal RCA occlusion increases the risk of arrhythmia and shock leading to increase the mortality. Sinus bradycardia and cardiogenic shock accounts for the majorities of the mortalities of RCA occlusion
Read the detailed description
Myocardial infarction is a common presentation of coronary artery disease. The World Health Organization estimated in 2004, that 12.2% of worldwide deaths were from ischemic heart disease; with it being the leading cause of death in high- or middle-income countries and second only to lower respiratory infections in lower-income countries. Worldwide, more than 3 million people have STEMIs and 4 million have NSTEMIs a year . STEMIs occur about twice as often in men as women .
Myocardial infarction means that the tissue ischemia caused tissue death, as a result of diminished blood supply to a part of the heart muscles. The blood supply of the heart is coronary arteries (right and left). Proximal RCA occlusions were very often found among men with fatal pre-hospital MI; whereas left-sided coronary occlusions were significantly more frequent in hospital-admitted survivors of MI. Left-sided coronary occlusions may be associated with a more favorable pre-hospital phase of acute MI compared to proximal RCA occlusions .
The right coronary artery (RCA) supplies the right ventricle, 25% to 35% of the left ventricle and SA node in 60% of people. Proximal RCA occlusion increases the risk of arrhythmia and shock leading to increase the mortality. Sinus bradycardia and cardiogenic shock accounts for the majorities of the mortalities of RCA occlusion.
Sinus bradycardia is more frequent when the infarct-related artery is the RCA than other arteries involvement. Proximal occlusions of the RCA presented sinus bradycardia more than medial and distal occlusions.
Mortality of cardiogenic shock due to right ventricular infarction (55%) was comparable to that due to left ventricular infarction (59%) in spite of patients being younger and a greater incidence of single vessel disease. The worse prognosis in patients with RV myocardial involvement may be related to the increased risk of life-threatening ventricular arrhythmias in these patients.
Approximately one half of patients who present with signs and symptoms of acute inferior myocardial infarction have proximal occlusion of the dominant right coronary artery (RCA) and also show ECG signs of RV wall ischemia or infarction. Occlusion sufficiently proximal to cause RV free wall injury also frequently compromises the blood supply to the sinoatrial node, atrium and atrioventricular (AV) node, producing such effects as sinus bradycardia, atrial infarction, atrial fibrillation and AV block.
The transthoracic echocardiography is the most common method to assess the function of the right ventricular function as it non-invasive, inexpensive and available in most of the hospitals. The presence of RV dysfunction on early echocardiography is an important predictor of an adverse prognosis, both short-and long-term, in STEMI patients.
The Tissue Doppler Imaging method depicts myocardial motion (measured as tissue velocity) at specific locations in the heart. Tissue velocity indicates the rate at which a particular point in the myocardium moves toward or away from the transducer. Integration of velocity over time yields displacement or the absolute distance moved by that point.
Evaluation of right ventricular function by echocardiography is challenging and often ignored in clinical practice. Tricuspid annular velocity correlates with right ventricular ejection fraction . Tricuspid annular excursion (tricuspid displacement) predicted 2-year survival in patients with pulmonary hypertension . Isovolumic acceleration, derived from tissue velocity, is a load-independent measure of contractility and correlates with right ventricular end-systolic elastance. This correlation is less pronounced in clinical studies . More recent experimental data suggest a weak relationship between isovolumic acceleration and regional contractility. Systolic velocity and strain best correlated with invasively determined right ventricular stroke volume and dynamically tracked changes in right ventricular function during vasodilator infusion. Strain rates and strain quantitate regional right ventricular systolic function in various pathologies
- Conditions
- Right Coronary Artery Occlusion
- Being tested
- echocardiography study
- Keywords
- RCA, PCI, right ventricular function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiography studyDiagnostic test
Patients with right coronary artery occlusion lesion will be subjected to:
- Written consent.
- Complete history.
- Complete physical examination.
- Trans-thoracic echocardiography assessment of the right ventricular function before PCI to the RCA
- Follow up Trans-thoracic echocardiography assessment of the right ventricular function four weeks after the PCI.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in RV function PCI to RCA
The aim of the study is to determine the impact of elective PCI of RCA on RV systolic and diastolic functions.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start1 Jun 2018
- Primary completion15 Aug 2018 (estimated)
- Study completion28 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Right Coronary Artery OcclusionStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hazim Alaa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543345
- Sponsor's protocol ID
- HAZ190
- Status last verified
- Jun 2018
- First submitted
- 21 May 2018
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Changes in The Right Ventricular Function After Elective Percutaneous Coronary Intervention in Patients With Right Coronary Artery Occlusion
- ClinicalTrials.gov ID
- NCT03543345
- Acronym / sponsor ID
- HAZ190
- Conditions
- Right Coronary Artery Occlusion
- Keywords
- RCA, PCI, right ventricular function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 15 Aug 2018 (estimated)
- Study completion
- 28 Aug 2018 (estimated)
- First posted
- 1 Jun 2018 (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.
Proximal RCA occlusions were very often found among men with fatal pre-hospital MI; whereas left-sided coronary occlusions were significantly more frequent in hospital-admitted survivors of MI. Left-sided coronary occlusions may be associated with a more favorable pre-hospital phase of acute MI compared to proximal RCA occlusions. Proximal RCA occlusion increases the risk of arrhythmia and shock leading to increase the mortality. Sinus bradycardia and cardiogenic shock accounts for the majorities of the mortalities of RCA occlusion
Detailed description
Myocardial infarction is a common presentation of coronary artery disease. The World Health Organization estimated in 2004, that 12.2% of worldwide deaths were from ischemic heart disease; with it being the leading cause of death in high- or middle-income countries and second only to lower respiratory infections in lower-income countries. Worldwide, more than 3 million people have STEMIs and 4 million have NSTEMIs a year . STEMIs occur about twice as often in men as women .
Myocardial infarction means that the tissue ischemia caused tissue death, as a result of diminished blood supply to a part of the heart muscles. The blood supply of the heart is coronary arteries (right and left). Proximal RCA occlusions were very often found among men with fatal pre-hospital MI; whereas left-sided coronary occlusions were significantly more frequent in hospital-admitted survivors of MI. Left-sided coronary occlusions may be associated with a more favorable pre-hospital phase of acute MI compared to proximal RCA occlusions .
The right coronary artery (RCA) supplies the right ventricle, 25% to 35% of the left ventricle and SA node in 60% of people. Proximal RCA occlusion increases the risk of arrhythmia and shock leading to increase the mortality. Sinus bradycardia and cardiogenic shock accounts for the majorities of the mortalities of RCA occlusion.
Sinus bradycardia is more frequent when the infarct-related artery is the RCA than other arteries involvement. Proximal occlusions of the RCA presented sinus bradycardia more than medial and distal occlusions.
Mortality of cardiogenic shock due to right ventricular infarction (55%) was comparable to that due to left ventricular infarction (59%) in spite of patients being younger and a greater incidence of single vessel disease. The worse prognosis in patients with RV myocardial involvement may be related to the increased risk of life-threatening ventricular arrhythmias in these patients.
Approximately one half of patients who present with signs and symptoms of acute inferior myocardial infarction have proximal occlusion of the dominant right coronary artery (RCA) and also show ECG signs of RV wall ischemia or infarction. Occlusion sufficiently proximal to cause RV free wall injury also frequently compromises the blood supply to the sinoatrial node, atrium and atrioventricular (AV) node, producing such effects as sinus bradycardia, atrial infarction, atrial fibrillation and AV block.
The transthoracic echocardiography is the most common method to assess the function of the right ventricular function as it non-invasive, inexpensive and available in most of the hospitals. The presence of RV dysfunction on early echocardiography is an important predictor of an adverse prognosis, both short-and long-term, in STEMI patients.
The Tissue Doppler Imaging method depicts myocardial motion (measured as tissue velocity) at specific locations in the heart. Tissue velocity indicates the rate at which a particular point in the myocardium moves toward or away from the transducer. Integration of velocity over time yields displacement or the absolute distance moved by that point.
Evaluation of right ventricular function by echocardiography is challenging and often ignored in clinical practice. Tricuspid annular velocity correlates with right ventricular ejection fraction . Tricuspid annular excursion (tricuspid displacement) predicted 2-year survival in patients with pulmonary hypertension . Isovolumic acceleration, derived from tissue velocity, is a load-independent measure of contractility and correlates with right ventricular end-systolic elastance. This correlation is less pronounced in clinical studies . More recent experimental data suggest a weak relationship between isovolumic acceleration and regional contractility. Systolic velocity and strain best correlated with invasively determined right ventricular stroke volume and dynamically tracked changes in right ventricular function during vasodilator infusion. Strain rates and strain quantitate regional right ventricular systolic function in various pathologies
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients subjected to elective PCI due to right coronary artery occlusion. Patients between 40 and 75 years old from the both genders
Key inclusion criteria (1 listed)
- Patients subjected to elective PCI due to right coronary artery occlusion. Patients between 40 and 75 years old from the both genders
Key exclusion criteria (12 listed)
- History of chronic respiratory condition and PHTN
- Patients with previous percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG).
- History of valvular surgery.
- Patients with significant rheumatic vavular heart disease.
- Presence of persistant arrythemia
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 |
|---|---|---|
| echocardiography studyPatients with right coronary artery occlusion lesion will be subjected to: * Written consent. * Complete history. * Complete physical examination. * Trans-thoracic echocardiography assessment of the right ventricular function before PCI to the RCA * Follow up Trans-thoracic echocardiography assessment of the right ventricular function four weeks after the PCI. | Diagnostic test | – |
Primary outcome
Change in RV function PCI to RCA
Time frame: 3 months
The aim of the study is to determine the impact of elective PCI of RCA on RV systolic and diastolic functions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
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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.
Mahmoud A. Abd Elbaset, MD contact
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 Right Coronary Artery Occlusion, run by Assiut University at 1 site in Egypt.
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 12 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 19 Jun 2018. 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 Egypt. 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 Hazim A. Kaml, MBcCH (+201118186565, ihazim1990@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in RV function PCI to RCA (time frame: 3 months). 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 19 Jun 2018.