Acute Myocardial Infarction of Inferior Wall Involving Right Ventricle (Disorder)NCT03165266
Right Ventricular Involvement in Inferior Myocardial Infarction Patients Using 2 Dimensional Speckle Tracking Echocardiography
An observational study of Acute Myocardial Infarction of Inferior Wall Involving Right Ventricle (Disorder), run by Assiut University.
Trial summary
Right ventricular infarction usually occurs in association with inferior myocardial infarction in about 10-50% of the cases. Currently the presence of elevation in right pericordial leads is the most powerful indicator of right ventricular infarction. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Myocardial Infarction of Inferior Wall Involving Right Ventricle (Disorder)
- What is being tested?
- Two dimensional Echocardiography
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2017to 28 Feb 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the study include patients with Acute inferior Myocardial in Assuit University Hospital in the duration beginning from June 2017 .
Who may be able to join
- Patients of recent acute inferior myocardial infarction.
- Patients managed by Primary percutaneous coronary intervention.
Who cannot join
- Pervious inferior Myocardial Infarction.
- Inferior Myocardial Infarction treated by thrombolytic therapy.
- Chronic pulmonary disease.
- estimatedPulmonary Artery Systolic Pressure ≥35 mmHg by Echocardiography.
- Valvular heart disease. 6- Dilated cardio-myopathy patients.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Incremental Role of 2 Dimensional Speckle Tracking Echocardiography in Diagnosis of Right Ventricular Involvement in Patients With Inferior Wall Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
Right ventricular infarction usually occurs in association with inferior myocardial infarction in about 10-50% of the cases. Currently the presence of elevation in right pericordial leads is the most powerful indicator of right ventricular infarction.
The incidence of right ventricular infarction is more in postmortem studies,meaning that Right ventricular infarction is underestimated, possible explanation for this difference could be explained that electrocardiographic sign of Right ventricular infarction disappear early or patients presented late.
Read the detailed description
The incidence of right ventricular infarction is more in postmortem studies,meaning that Right ventricular infarction is underestimated, possible explanation for this difference could be explained that electrocardiographic sign of Right ventricular infarction disappear early or patients presented late
The role of Right ventricular systolic function in inferior myocardial infarction patients with or without Right ventricular infarction Had been studied. In our study we will Assess Right Ventricular infarction in patients of acute inferior myocardial infarction undergoing primary percutaneous coronary intervention by correlating electrocardiogram, Right ventricular systolic function by echocardiography with the angiographic finding.
- Being tested
- Two dimensional Echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two dimensional EchocardiographyDiagnostic test
I- Routine transthoracic assessment for Left Atrium and Left Ventricle dimensions :
II- transthoracic assessment of the Right ventricular systolic function by:
- . Right Ventricle fractional area change.
- . Tricuspid annular plane systolic excursion .
- . Tissue Doppler derived tricuspid annular systolic velocity.
- . Right ventricle myocardial performance index . III- Assessment of Right ventricular diastolic function: is carried out by pulsed Doppler of the tricuspid inflow, or tissue Doppler of the lateral tricuspid annulus.
IV Assessment of Right Ventricle chamber quantification:
- Right ventricular basal, mid ,and longitudinal dimensions.
- Right ventricular Outflow Tract, and wall thickness V- Assessment of right atrial major ,and minor dimensions ,and right atrial End- systolic area IV- Assessment of longitudinal Right ventricular strain and strain rate by speckle tracking
What is being measured
The primary outcome is the main question the study is designed to answer.
Right ventricular dysfunction
right ventricular dysfunction by Echocardiography as indicator of right ventricular infarction in inferior wll myocardial patients
Measured: 3days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start1 Jun 2017 (estimated)
- Primary completion1 Jan 2018 (estimated)
- Study completion28 Feb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial Infarction of Inferior Wall Involving Right Ventricle (Disorder)Studies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EGAbdelrhman, Assiut University
- Investigators
- Marwa M Abdelmohsen, Lecturer, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03165266
- Sponsor's protocol ID
- RVINFMI
- Status last verified
- May 2017
- First submitted
- 19 May 2017
- Last updated
- 24 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Andersen HR, Nielsen D, Falk E. Right ventricular infarction: larger enzyme release with posterior than with anterior involvement. Int J Cardiol. 1989 Mar;22(3):347-55. doi: 10.1016/0167-5273(89)90276-3.
PubMed 2707915Andersen HR, Falk E, Nielsen D. Right ventricular infarction: frequency, size and topography in coronary heart disease: a prospective study comprising 107 consecutive autopsies from a coronary care unit. J Am Coll Cardiol. 1987 Dec;10(6):1223-32. doi: 10.1016/s0735-1097(87)80122-5.
PubMed 3680789Wagner GS, Macfarlane P, Wellens H, Josephson M, Gorgels A, Mirvis DM, Pahlm O, Surawicz B, Kligfield P, Childers R, Gettes LS, Bailey JJ, Deal BJ, Gorgels A, Hancock EW, Kors JA, Mason JW, Okin P, Rautaharju PM, van Herpen G; American Heart Association Electrocardiography and Arrhythmias Committee, Council on Clinical Cardiology; American College of Cardiology Foundation; Heart Rhythm Society. AHA/ACCF/HRS recommendations for the standardization and interpretation of the electrocardiogram: part VI: acute ischemia/infarction: a scientific statement from the American Heart Association Electrocardiography and Arrhythmias Committee, Council on Clinical Cardiology; the American College of Cardiology Foundation; and the Heart Rhythm Society. Endorsed by the International Society for Computerized Electrocardiology. J Am Coll Cardiol. 2009 Mar 17;53(11):1003-11. doi: 10.1016/j.jacc.2008.12.016. No abstract available.
PubMed 19281933Javed S, Rajani AR, Govindaswamy P, Radaideh GA, Abubaraka HA, Qureshi TI, Arshad HB. Right ventricular involvement in patients with inferior myocardial infarction, correlation of electrocardiographic findings with echocardiography data. J Pak Med Assoc. 2017 Mar;67(3):442-445.
PubMed 28303997Zornoff LA, Skali H, Pfeffer MA, St John Sutton M, Rouleau JL, Lamas GA, Plappert T, Rouleau JR, Moye LA, Lewis SJ, Braunwald E, Solomon SD; SAVE Investigators. Right ventricular dysfunction and risk of heart failure and mortality after myocardial infarction. J Am Coll Cardiol. 2002 May 1;39(9):1450-5. doi: 10.1016/s0735-1097(02)01804-1.
PubMed 11985906O'Rourke RA, Dell'Italia LJ. Diagnosis and management of right ventricular myocardial infarction. Curr Probl Cardiol. 2004 Jan;29(1):6-47. doi: 10.1016/j.cpcardiol.2003.08.003. No abstract available.
PubMed 14872197Bayata S, Avci E, Yesil M, Arikan E, Postaci N, Tuluce SY. Tricuspid annular motion in right coronary artery-related acute inferior myocardial infarction with or without right ventricular involvement. Anadolu Kardiyol Derg. 2011 Sep;11(6):504-8. doi: 10.5152/akd.2011.134. Epub 2011 Jul 25.
PubMed 21788200Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010. No abstract available.
PubMed 20620859
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incremental Role of 2 Dimensional Speckle Tracking Echocardiography in Diagnosis of Right Ventricular Involvement in Patients With Inferior Wall Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT03165266
- Acronym / sponsor ID
- RVINFMI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (estimated)
- Primary completion
- 1 Jan 2018 (estimated)
- Study completion
- 28 Feb 2018 (estimated)
- First posted
- 24 May 2017 (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.
Right ventricular infarction usually occurs in association with inferior myocardial infarction in about 10-50% of the cases. Currently the presence of elevation in right pericordial leads is the most powerful indicator of right ventricular infarction.
The incidence of right ventricular infarction is more in postmortem studies,meaning that Right ventricular infarction is underestimated, possible explanation for this difference could be explained that electrocardiographic sign of Right ventricular infarction disappear early or patients presented late.
Detailed description
The incidence of right ventricular infarction is more in postmortem studies,meaning that Right ventricular infarction is underestimated, possible explanation for this difference could be explained that electrocardiographic sign of Right ventricular infarction disappear early or patients presented late
The role of Right ventricular systolic function in inferior myocardial infarction patients with or without Right ventricular infarction Had been studied. In our study we will Assess Right Ventricular infarction in patients of acute inferior myocardial infarction undergoing primary percutaneous coronary intervention by correlating electrocardiogram, Right ventricular systolic function by echocardiography with the angiographic finding.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the study include patients with Acute inferior Myocardial in Assuit University Hospital in the duration beginning from June 2017 .
Key inclusion criteria (2 listed)
- Patients of recent acute inferior myocardial infarction.
- Patients managed by Primary percutaneous coronary intervention.
Key exclusion criteria (5 listed)
- Pervious inferior Myocardial Infarction.
- Inferior Myocardial Infarction treated by thrombolytic therapy.
- Chronic pulmonary disease.
- estimatedPulmonary Artery Systolic Pressure ≥35 mmHg by Echocardiography.
- Valvular heart disease. 6- Dilated cardio-myopathy patients.
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 |
|---|---|---|
| Two dimensional EchocardiographyI- Routine transthoracic assessment for Left Atrium and Left Ventricle dimensions : II- transthoracic assessment of the Right ventricular systolic function by: 1. . Right Ventricle fractional area change. 2. . Tricuspid annular plane systolic excursion . 3. . Tissue Doppler derived tricuspid annular systolic velocity. 4. . Right ventricle myocardial performance index . III- Assessment of Right ventricular diastolic function: is carried out by pulsed Doppler of the tricuspid inflow, or tissue Doppler of the lateral tricuspid annulus. IV Assessment of Right Ventricle chamber quantification: * Right ventricular basal, mid ,and longitudinal dimensions. * Right ventricular Outflow Tract, and wall thickness V- Assessment of right atrial major ,and minor dimensions ,and right atrial End- systolic area IV- Assessment of longitudinal Right ventricular strain and strain rate by speckle tracking | Diagnostic test | – |
Primary outcome
Right ventricular dysfunction
Time frame: 3days
right ventricular dysfunction by Echocardiography as indicator of right ventricular infarction in inferior wll myocardial patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
- Background: PubMed 2707915Andersen HR, Nielsen D, Falk E. Right ventricular infarction: larger enzyme release with posterior than with anterior involvement. Int J Cardiol. 1989 Mar;22(3):347-55. doi: 10.1016/0167-5273(89)90276-3.
- Background: PubMed 3680789Andersen HR, Falk E, Nielsen D. Right ventricular infarction: frequency, size and topography in coronary heart disease: a prospective study comprising 107 consecutive autopsies from a coronary care unit. J Am Coll Cardiol. 1987 Dec;10(6):1223-32. doi: 10.1016/s0735-1097(87)80122-5.
- Background: PubMed 19281933Wagner GS, Macfarlane P, Wellens H, Josephson M, Gorgels A, Mirvis DM, Pahlm O, Surawicz B, Kligfield P, Childers R, Gettes LS, Bailey JJ, Deal BJ, Gorgels A, Hancock EW, Kors JA, Mason JW, Okin P, Rautaharju PM, van Herpen G; American Heart Association Electrocardiography and Arrhythmias Committee, Council on Clinical Cardiology; American College of Cardiology Foundation; Heart Rhythm Society. AHA/ACCF/HRS recommendations for the standardization and interpretation of the electrocardiogram: part VI: acute ischemia/infarction: a scientific statement from the American Heart Association Electrocardiography and Arrhythmias Committee, Council on Clinical Cardiology; the American College of Cardiology Foundation; and the Heart Rhythm Society. Endorsed by the International Society for Computerized Electrocardiology. J Am Coll Cardiol. 2009 Mar 17;53(11):1003-11. doi: 10.1016/j.jacc.2008.12.016. No abstract available.
- Background: PubMed 28303997Javed S, Rajani AR, Govindaswamy P, Radaideh GA, Abubaraka HA, Qureshi TI, Arshad HB. Right ventricular involvement in patients with inferior myocardial infarction, correlation of electrocardiographic findings with echocardiography data. J Pak Med Assoc. 2017 Mar;67(3):442-445.
- Background: PubMed 11985906Zornoff LA, Skali H, Pfeffer MA, St John Sutton M, Rouleau JL, Lamas GA, Plappert T, Rouleau JR, Moye LA, Lewis SJ, Braunwald E, Solomon SD; SAVE Investigators. Right ventricular dysfunction and risk of heart failure and mortality after myocardial infarction. J Am Coll Cardiol. 2002 May 1;39(9):1450-5. doi: 10.1016/s0735-1097(02)01804-1.
- Background: PubMed 14872197O'Rourke RA, Dell'Italia LJ. Diagnosis and management of right ventricular myocardial infarction. Curr Probl Cardiol. 2004 Jan;29(1):6-47. doi: 10.1016/j.cpcardiol.2003.08.003. No abstract available.
- Background: PubMed 21788200Bayata S, Avci E, Yesil M, Arikan E, Postaci N, Tuluce SY. Tricuspid annular motion in right coronary artery-related acute inferior myocardial infarction with or without right ventricular involvement. Anadolu Kardiyol Derg. 2011 Sep;11(6):504-8. doi: 10.5152/akd.2011.134. Epub 2011 Jul 25.
- Background: PubMed 20620859Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010. No abstract available.
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.
Marwa M Abdelmohsen, Lecturer study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction of Inferior Wall Involving Right Ventricle (Disorder), run by Assiut 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 2 inclusion and 5 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 24 May 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hossam H El-Araby, Prof (00201223971327, hosam_hasan@hotmail.com.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Right ventricular dysfunction (time frame: 3days). 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 NCT03165266, which also lists 8 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 24 May 2017.