Primary Percutaneous Coronary InterventionNCT04332250
Influence Of Incomplete Revascularization on Long-Term Outcomes After Primary Percutaneous Coronary Intervention (PPCI)
An observational study of Primary Percutaneous Coronary Intervention, run by Amany Edward Ramzy.
Trial summary
evaluate the influence of incomplete revascularization during the index hospitalization on in-hospital and long-term outcomes in STEMI patients undergoing PPCI in Assiut University heart hospital. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Percutaneous Coronary Intervention
- How many people
- 3,200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 30 Dec 2019
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All Patients aged >18 years with STEMI admitted to Assiut University Heart hospital and underwent successful PPCI between January 2016 to December 2019 were recruited. Selection of patients for primary PCI was as per guideline recommendations
Who may be able to join
- All Patients aged >18 years with STEMI admitted to Assiut University Heart hospital and underwent successful PPCI between January 2016 to December 2019 were recruited. Selection of patients for primary PCI was as per guideline recommendations.
- -
Who cannot join
- Patients with incomplete data.
- Patients with previous coronary artery bypass grafting (CABG).
- Patients presenting with cardiogenic shock, cardiac arrest or pulmonary edema.
- Mechanical complications of MI; namely VSD, wall rupture, mitral regurgitation secondary to papillary muscle or chordal rupture.
- Patients with unsuccessful PPCI with a final TIMI flow ≤ I in infarct related artery.
- Patients with a significant co-morbidity reducing life expectancy to <1 year as patients with advanced liver diseases, cerebrovascular diseases, malignancy and chronic lung diseases that could affect patient prognosis
About this study
Official title: Influence Of Incomplete Revascularization on Long-Term Outcomes After Primary Percutaneous Coronary Intervention (PPCI). A Single Center Real-Life Retrospective Analysis
evaluate the influence of incomplete revascularization during the index hospitalization on in-hospital and long-term outcomes in STEMI patients undergoing PPCI in Assiut University heart hospital.
Read the detailed description
- Study groups: Patients will be divided into 2 groups
- Group I: Complete revascularization was achieved by PPCI.
- Group II: Complete revascularization was not achieved by PPCI.
- In hospital outcomes: All the patients will be reviewed for during hospital admission to record major acute cardiac events (MACE). Only the most serious event of major adverse cardiac events will be used to calculate the cumulative major adverse cardiac events per patient according to the following sequence: (death > heart failure > recurrent non-fatal MI > serious secondary arrhythmia necessitating DC shock> recurrent or refractory angina. MACE will be reported according to the standard definitions.(Tsai IT, et al.,2017)
- Long-term follow-up: The patients will be followed by telephone interviews for all-cause mortality, re-hospitalization by ACS, re-hospitalization by heart failure, planned and unplanned PCI or CABG. Long-term MACE will include: all-cause mortality, re-hospitalization by ACS, re-hospitalization by heart failure, unplanned revascularization. Patients who undergo planned revascularization later on after discharge will be followed till the date of revascularization for actual events and will be censored in Kaplan Meier Survival analysis. These patients will be included in a third group of staged late complete revascularization to be followed for the long-term MACE events starting from the planned revascularization procedure.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mace
All the patients will be reviewed for during hospital admission to record major acute cardiac events (MACE). Only the most serious event of major adverse cardiac events will be used to calculate the cumulative major adverse cardiac events per patient according to the following sequence: (death > heart failure > recurrent non-fatal MI > serious secondary arrhythmia necessitating DC shock> recurrent or refractory angina. MACE will be reported according to the standard definitions
Measured: between January 2016 to December 2019 were recruited
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start1 Jan 2016
- Primary completion1 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Percutaneous Coronary InterventionStudies 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
- Retrospective
- Enrolment
- 3,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amany Edward Ramzy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amany Edward Ramzy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04332250
- Sponsor's protocol ID
- Amany Edward Ramzy
- Status last verified
- Apr 2020
- First submitted
- 31 Mar 2020
- Last updated
- 3 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence Of Incomplete Revascularization on Long-Term Outcomes After Primary Percutaneous Coronary Intervention (PPCI). A Single Center Real-Life Retrospective Analysis
- ClinicalTrials.gov ID
- NCT04332250
- Acronym / sponsor ID
- Amany Edward Ramzy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,200 participants (actual)
- Lead sponsor
- Amany Edward RamzyUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 2 Apr 2020 (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.
evaluate the influence of incomplete revascularization during the index hospitalization on in-hospital and long-term outcomes in STEMI patients undergoing PPCI in Assiut University heart hospital.
Detailed description
- Study groups: Patients will be divided into 2 groups
- Group I: Complete revascularization was achieved by PPCI.
- Group II: Complete revascularization was not achieved by PPCI.
- In hospital outcomes: All the patients will be reviewed for during hospital admission to record major acute cardiac events (MACE). Only the most serious event of major adverse cardiac events will be used to calculate the cumulative major adverse cardiac events per patient according to the following sequence: (death > heart failure > recurrent non-fatal MI > serious secondary arrhythmia necessitating DC shock> recurrent or refractory angina. MACE will be reported according to the standard definitions.(Tsai IT, et al.,2017)
- Long-term follow-up: The patients will be followed by telephone interviews for all-cause mortality, re-hospitalization by ACS, re-hospitalization by heart failure, planned and unplanned PCI or CABG. Long-term MACE will include: all-cause mortality, re-hospitalization by ACS, re-hospitalization by heart failure, unplanned revascularization. Patients who undergo planned revascularization later on after discharge will be followed till the date of revascularization for actual events and will be censored in Kaplan Meier Survival analysis. These patients will be included in a third group of staged late complete revascularization to be followed for the long-term MACE events starting from the planned revascularization procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All Patients aged >18 years with STEMI admitted to Assiut University Heart hospital and underwent successful PPCI between January 2016 to December 2019 were recruited. Selection of patients for primary PCI was as per guideline recommendations
Key inclusion criteria (2 listed)
- All Patients aged >18 years with STEMI admitted to Assiut University Heart hospital and underwent successful PPCI between January 2016 to December 2019 were recruited. Selection of patients for primary PCI was as per guideline recommendations.
- -
Key exclusion criteria (6 listed)
- Patients with incomplete data.
- Patients with previous coronary artery bypass grafting (CABG).
- Patients presenting with cardiogenic shock, cardiac arrest or pulmonary edema.
- Mechanical complications of MI; namely VSD, wall rupture, mitral regurgitation secondary to papillary muscle or chordal rupture.
- Patients with unsuccessful PPCI with a final TIMI flow ≤ I in infarct related artery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mace
Time frame: between January 2016 to December 2019 were recruited
All the patients will be reviewed for during hospital admission to record major acute cardiac events (MACE). Only the most serious event of major adverse cardiac events will be used to calculate the cumulative major adverse cardiac events per patient according to the following sequence: (death > heart failure > recurrent non-fatal MI > serious secondary arrhythmia necessitating DC shock> recurrent or refractory angina. MACE will be reported according to the standard definitions
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 3 Apr 2020.
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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 Primary Percutaneous Coronary Intervention, run by Amany Edward Ramzy.
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 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 3 Apr 2020. 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?
Mace (time frame: between January 2016 to December 2019 were recruited). 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 3 Apr 2020.