Inferior Wall; Transmural Myocardial InfarctionNCT06424028
Acute Right Ventricular Infarction Registry
An observational study of Inferior Wall; Transmural Myocardial Infarction and Right Ventricular Dysfunction, run by National Institute of Cardiovascular Diseases, Pakistan at 1 site in Pakistan.
Trial summary
This Study aims to provide an assessment of clinical presentation, management, hospital course, and prognosis of acute right ventricular infarction presenting with or without Inferior or infero-posterior wall Myocardial Infarction and the assessment of composite adverse clinical outcome after reperfusion in-hospital… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inferior Wall; Transmural Myocardial Infarction, Right Ventricular Dysfunction
- What is being tested?
- Right Ventricular Infarct
- How many people
- 1,000 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Jan 2024to 19 Aug 2024
- How long will I take part?
- 30 Days
- 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: Patients presented at a tertiary care hospital with Inferior and posterior wall MI with and without RV infarction undergoing PPCI who are fulfilling the eligibility criteria will be enrolled.
Who may be able to join
- Patients of Inferior, infero-lateral and infero-posterior wall MI with and without RV infarction undergoing PPCI.
- Both male and female patients.
- Patients of age ≥ 18 years.
Who cannot join
- Patients who will not give consent for participation.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
National Institute of Cardiovascular Diseases
Karachi, Sindh, 75510
Rajesh Kumar, MBBS, FCPS, +923337306090, rajeshnarsoolal@@gmail.com
About this study
Official title: Presentation, Management, Hospital-course, and Prognosis of Acute Right Ventricular Infarction: A Prospective Registry of Patients Presenting to the Largest Primary Percutaneous Coronary Intervention Centre of Pakistan
This Study aims to provide an assessment of clinical presentation, management, hospital course, and prognosis of acute right ventricular infarction presenting with or without Inferior or infero-posterior wall Myocardial Infarction and the assessment of composite adverse clinical outcome after reperfusion in-hospital and post-discharge (in 30 Days Prognosis).
Read the detailed description
After fulfilling the eligibility criteria, informed consent will be obtained from all the patients regarding using data for research while maintaining anonymity.Data will be collected for various patient, system, and procedure related characteristics with the help of a predefined structured proforma consisted of demographic data, clinical presentation, history and co-morbid conditions, and angiographic and procedural characteristics. All the recruited patients will be kept under observiton during the hospital stay and a telephonic follow-up will be carried out after 30-days of discharge and occurrence of the MACE will be recorded.
Univariate and multivariable binary logistic regression analysis will be performed to determine the clinical predictors of RVI. Odds ratio (OR) along with 95% confidence interval (CI) will be reported. The statistical significance criteria will be set as p-value<0.05.
For data verification, 10% of the data will be cross-checked with the source document (Patient file).
- Being tested
- Right Ventricular Infarct
- Medical subject headings
- Ventricular Dysfunction, Right
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right Ventricular InfarctOther
Consecutive patients presented with isolated inferior, infero-posterior and inferolateral wall MI with or without acute right ventricular infarction.
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite adverse clinical outcome
Atleast one adverse event, such as pump failure, cerebrovascular accident (CVA), stent thrombosis, major bleeding, contrast-induced nephropathy (CIN), ventricular arrhythmias, or mortality.
Measured: Upto 30 days from admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start20 Jan 2024
- Primary completion19 Jul 2024 (estimated)
- Study completion19 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inferior Wall; Transmural Myocardial InfarctionStudies 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
- 1,000 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiovascular Diseases, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Rajesh Kumar, National Institute of Cardiovascular Diseases, Pakistan
- Investigators
- Rajesh Kumar, MBBS, FCPS, Principal investigator, National Institute of Cardiovascular Diaseses
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424028
- Sponsor's protocol ID
- IRB-62/2023
- Status last verified
- May 2024
- First submitted
- 10 May 2024
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Hospital Medical Record number will be used as the patient identifier.
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presentation, Management, Hospital-course, and Prognosis of Acute Right Ventricular Infarction: A Prospective Registry of Patients Presenting to the Largest Primary Percutaneous Coronary Intervention Centre of Pakistan
- ClinicalTrials.gov ID
- NCT06424028
- Acronym / sponsor ID
- IRB-62/2023
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- National Institute of Cardiovascular Diseases, PakistanUniversity, hospital or other
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 19 Jul 2024 (estimated)
- Study completion
- 19 Aug 2024 (estimated)
- First posted
- 21 May 2024 (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.
This Study aims to provide an assessment of clinical presentation, management, hospital course, and prognosis of acute right ventricular infarction presenting with or without Inferior or infero-posterior wall Myocardial Infarction and the assessment of composite adverse clinical outcome after reperfusion in-hospital and post-discharge (in 30 Days Prognosis).
Detailed description
After fulfilling the eligibility criteria, informed consent will be obtained from all the patients regarding using data for research while maintaining anonymity.Data will be collected for various patient, system, and procedure related characteristics with the help of a predefined structured proforma consisted of demographic data, clinical presentation, history and co-morbid conditions, and angiographic and procedural characteristics. All the recruited patients will be kept under observiton during the hospital stay and a telephonic follow-up will be carried out after 30-days of discharge and occurrence of the MACE will be recorded.
Univariate and multivariable binary logistic regression analysis will be performed to determine the clinical predictors of RVI. Odds ratio (OR) along with 95% confidence interval (CI) will be reported. The statistical significance criteria will be set as p-value<0.05.
For data verification, 10% of the data will be cross-checked with the source document (Patient file).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presented at a tertiary care hospital with Inferior and posterior wall MI with and without RV infarction undergoing PPCI who are fulfilling the eligibility criteria will be enrolled.
Key inclusion criteria (3 listed)
- Patients of Inferior, infero-lateral and infero-posterior wall MI with and without RV infarction undergoing PPCI.
- Both male and female patients.
- Patients of age ≥ 18 years.
Key exclusion criteria (1 listed)
- Patients who will not give consent for participation.
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 |
|---|---|---|
| Right Ventricular InfarctConsecutive patients presented with isolated inferior, infero-posterior and inferolateral wall MI with or without acute right ventricular infarction. | Other | – |
Primary outcome
Composite adverse clinical outcome
Time frame: Upto 30 days from admission
Atleast one adverse event, such as pump failure, cerebrovascular accident (CVA), stent thrombosis, major bleeding, contrast-induced nephropathy (CIN), ventricular arrhythmias, or mortality.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Individual participant dataSharing planned: No. The Hospital Medical Record number will be used as the patient identifier.
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.
Rajesh Kumar, MBBS, FCPS principal investigator
National Institute of Cardiovascular Diaseses
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 Inferior Wall; Transmural Myocardial Infarction and Right Ventricular Dysfunction, run by National Institute of Cardiovascular Diseases, Pakistan at 1 site in Pakistan.
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 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: status not confirmed, as of the sponsor's last update on 21 May 2024. 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 Pakistan. 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 Rajesh Kumar, MBBS, FCPS (+923337306090, rajeshnarsoolal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite adverse clinical outcome (time frame: Upto 30 days from admission). 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 21 May 2024.