Myocardial InfarctionNCT07519590
One-Time Complete Revascularization Versus Staged PCI in MVD During Pharmaco-Invasive STEMI Strategy
A study testing One-Time Complete Revascularization and Staged Percutaneous Coronary Intervention in people with Myocardial Infarction and Coronary Artery Disease, run by Tanta University at 1 site in Egypt.
Trial summary
This study compares two treatment strategies in patients with ST-elevation myocardial infarction (STEMI) and multivessel coronary artery disease (MVD) undergoing a pharmaco-invasive approach after successful fibrinolysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Coronary Artery Disease
- What is being tested?
- One-Time Complete Revascularization and Staged Percutaneous Coronary Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Apr 2023to 30 Jul 2024
- Phase
- Interventional
- 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
Who may be able to join
- Adults older than 18 years.
- Acute ST-elevation myocardial infarction treated with a pharmaco-invasive strategy.
- Successful fibrinolysis followed by coronary angiography and percutaneous coronary intervention.
- Multivessel coronary artery disease.
- Ability to provide written informed consent.
Who cannot join
- Primary percutaneous coronary intervention.
- Unsuccessful fibrinolysis requiring rescue percutaneous coronary intervention.
- Candidacy for coronary artery bypass grafting after angiography.
- Failed complete revascularization.
- Cardiogenic shock.
- Single-vessel coronary artery disease treated with a pharmaco-invasive strategy.
Show all 15Show fewer
- Stent thrombosis.
- Chronic total occlusion.
- Planned percutaneous transluminal coronary angioplasty to a non-culprit lesion in a vessel smaller than 2.5 millimeters with more than 70 percent stenosis.
- Severe valvular heart disease.
- Pregnancy.
- Prior cardiac surgery.
- Congenital heart disease.
- Severe hepatic impairment.
- Severe renal impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: One Time Complete Revascularization Versus Staged PCI in Multivessel Coronary Artery Disease During Pharmaco Invasive STEMI Strategy
This study compares two treatment strategies in patients with ST-elevation myocardial infarction (STEMI) and multivessel coronary artery disease (MVD) undergoing a pharmaco-invasive approach after successful fibrinolysis. The study evaluates whether one-time complete revascularization, in which the culprit and significant non-culprit lesions are treated during the same percutaneous coronary intervention (PCI) session, is better than a staged strategy, in which non-culprit lesions are treated in a separate percutaneous coronary intervention (PCI) procedure within 1 month.
The hypothesis is that one-time complete revascularization may reduce hospitalization time, cost, and recurrent ischemic symptoms without increasing short-term complications.
Participants are adults with acute ST-elevation myocardial infarction (STEMI) and multivessel coronary artery disease (MVD) who had successful fibrinolysis followed by coronary angiography and percutaneous coronary intervention (PCI). Outcomes include total hospitalization time, total expenses, contrast-induced nephropathy (CIN) within 72 hours, and major adverse cardiovascular events (MACE) during 3 months of follow-up.
- Conditions
- Myocardial Infarction, Coronary Artery Disease
- Being tested
- One-Time Complete Revascularization, Staged Percutaneous Coronary Intervention
- Keywords
- ST-elevation myocardial infarction, Multivessel coronary artery disease, Pharmaco-invasive strategy, Complete revascularization, Staged percutaneous coronary intervention, Fibrinolysis, Non-culprit lesion intervention, Primary percutaneous coronary intervention delay
- Medical subject headings
- Myocardial Infarction, Coronary Artery Disease, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-Time Complete RevascularizationProcedure or surgery
Revascularization strategy in which the culprit coronary artery and all significant non-culprit lesions are treated during the index percutaneous coronary intervention session after successful fibrinolysis.
Staged Percutaneous Coronary InterventionProcedure or surgery
Revascularization strategy in which only the culprit coronary artery is treated during the index percutaneous coronary intervention session after successful fibrinolysis, with treatment of significant non-culprit lesions deferred to a separate staged percutaneous coronary intervention within 1 month after discharge.
| Study group | Role | What they receive |
|---|---|---|
| One-Time Complete Revascularization | Experimental | Participants underwent one-time complete revascularization during the index percutaneous coronary intervention after successful fibrinolysis. The culprit coronary artery and all significant non-culprit lesions were treated during the same procedure. Receives: Procedure: One-Time Complete Revascularization |
| Staged Percutaneous Coronary Intervention | Active comparator | Participants underwent culprit-only percutaneous coronary intervention during the index procedure after successful fibrinolysis. Significant non-culprit lesions were treated in a separate staged percutaneous coronary intervention session within 1 month after discharge. Receives: Procedure: Staged Percutaneous Coronary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total hospitalization time
Total duration of hospitalization in days. For participants assigned to staged revascularization, the duration of the staged admission was added to the index admission to calculate the total hospitalization time.
Measured: up to 1 month post operatively
Secondary outcomes (6)
Total expenses
Total treatment-related expenses in Egyptian pounds for the index admission and, when applicable, the staged admission.
Measured: up to 1 month post operatively
Contrast-induced nephropathy
Increase in serum creatinine by at least 0.5 milligrams per deciliter or at least 25 percent from baseline within 72 hours after percutaneous coronary intervention.
Measured: Within 72 hours after percutaneous coronary intervention
Angina-related hospitalization
Hospital admission due to recurrent anginal symptoms during follow-up.
Measured: Within 3 months after index percutaneous coronary intervention
Left ventricular ejection fraction
Left ventricular systolic function assessed by transthoracic echocardiography using the modified Simpson method.
Measured: Baseline and 3 months after index percutaneous coronary intervention
Wall motion score index
Regional left ventricular wall motion score index assessed by transthoracic echocardiography.
Measured: Baseline and 3 months after index percutaneous coronary intervention
Serum creatinine
Serum creatinine concentration measured to assess renal function.
Measured: Baseline, 72 hours after percutaneous coronary intervention, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start30 Apr 2023
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized in a parallel two-arm design to undergo either one-time complete revascularization during the index percutaneous coronary intervention or culprit-only percutaneous coronary intervention followed by staged non-culprit percutaneous coronary intervention within 1 month after discharge.
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Collaborators
- Helwan University
- Responsible party
- Principal investigator, Ahmed Rashed Basyouny, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519590
- Sponsor's protocol ID
- 50-2023
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in this study will be made available to qualified researchers. Shared data may include baseline demographic and clinical characteristics, procedural data, laboratory results, echocardiographic findings, hospitalization data, and follow-up outcome data used in the published analyses. All shared data will be fully de-identified to protect participant privacy.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Time Complete Revascularization Versus Staged PCI in Multivessel Coronary Artery Disease During Pharmaco Invasive STEMI Strategy
- ClinicalTrials.gov ID
- NCT07519590
- Acronym / sponsor ID
- 50-2023
- Conditions
- Myocardial Infarction, Coronary Artery Disease
- Keywords
- ST-elevation myocardial infarction, Multivessel coronary artery disease, Pharmaco-invasive strategy, Complete revascularization, Staged percutaneous coronary intervention, Fibrinolysis, Non-culprit lesion intervention, Primary percutaneous coronary intervention delay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Collaborators
- Helwan University
- Study start
- 30 Apr 2023 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 9 Apr 2026 (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 compares two treatment strategies in patients with ST-elevation myocardial infarction (STEMI) and multivessel coronary artery disease (MVD) undergoing a pharmaco-invasive approach after successful fibrinolysis. The study evaluates whether one-time complete revascularization, in which the culprit and significant non-culprit lesions are treated during the same percutaneous coronary intervention (PCI) session, is better than a staged strategy, in which non-culprit lesions are treated in a separate percutaneous coronary intervention (PCI) procedure within 1 month.
The hypothesis is that one-time complete revascularization may reduce hospitalization time, cost, and recurrent ischemic symptoms without increasing short-term complications.
Participants are adults with acute ST-elevation myocardial infarction (STEMI) and multivessel coronary artery disease (MVD) who had successful fibrinolysis followed by coronary angiography and percutaneous coronary intervention (PCI). Outcomes include total hospitalization time, total expenses, contrast-induced nephropathy (CIN) within 72 hours, and major adverse cardiovascular events (MACE) during 3 months of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomized in a parallel two-arm design to undergo either one-time complete revascularization during the index percutaneous coronary intervention or culprit-only percutaneous coronary intervention followed by staged non-culprit percutaneous coronary intervention within 1 month after discharge.
| Arm | Type | Receives |
|---|---|---|
| One-Time Complete Revascularization | Experimental | Procedure: One-Time Complete RevascularizationParticipants underwent one-time complete revascularization during the index percutaneous coronary intervention after successful fibrinolysis. The culprit coronary artery and all significant non-culprit lesions were treated during the same procedure. |
| Staged Percutaneous Coronary Intervention | Active comparator | Procedure: Staged Percutaneous Coronary InterventionParticipants underwent culprit-only percutaneous coronary intervention during the index procedure after successful fibrinolysis. Significant non-culprit lesions were treated in a separate staged percutaneous coronary intervention session within 1 month after discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults older than 18 years.
- Acute ST-elevation myocardial infarction treated with a pharmaco-invasive strategy.
- Successful fibrinolysis followed by coronary angiography and percutaneous coronary intervention.
- Multivessel coronary artery disease.
- Ability to provide written informed consent.
Key exclusion criteria (15 listed)
- Primary percutaneous coronary intervention.
- Unsuccessful fibrinolysis requiring rescue percutaneous coronary intervention.
- Candidacy for coronary artery bypass grafting after angiography.
- Failed complete revascularization.
- Cardiogenic shock.
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 |
|---|---|---|
| One-Time Complete RevascularizationRevascularization strategy in which the culprit coronary artery and all significant non-culprit lesions are treated during the index percutaneous coronary intervention session after successful fibrinolysis. | Procedure or surgery | One-Time Complete Revascularization |
| Staged Percutaneous Coronary InterventionRevascularization strategy in which only the culprit coronary artery is treated during the index percutaneous coronary intervention session after successful fibrinolysis, with treatment of significant non-culprit lesions deferred to a separate staged percutaneous coronary intervention within 1 month after discharge. | Procedure or surgery | Staged Percutaneous Coronary Intervention |
Primary outcome
Total hospitalization time
Time frame: up to 1 month post operatively
Total duration of hospitalization in days. For participants assigned to staged revascularization, the duration of the staged admission was added to the index admission to calculate the total hospitalization time.
6 secondary outcomes
Total expenses
Time frame: up to 1 month post operatively
Contrast-induced nephropathy
Time frame: Within 72 hours after percutaneous coronary intervention
Angina-related hospitalization
Time frame: Within 3 months after index percutaneous coronary intervention
Left ventricular ejection fraction
Time frame: Baseline and 3 months after index percutaneous coronary intervention
Wall motion score index
Time frame: Baseline and 3 months after index percutaneous coronary intervention
Serum creatinine
Time frame: Baseline, 72 hours after percutaneous coronary intervention, and 3 months
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 9 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in this study will be made available to qualified researchers. Shared data may include baseline demographic and clinical characteristics, procedural data, laboratory results, echocardiographic findings, hospitalization data, and follow-up outcome data used in the published analyses. All shared data will be fully de-identified to protect participant privacy.
Related trials for Myocardial Infarction
Recruiting
ODSSEY-SCD_Identification Of Markers to preDict the rISk of Sudden Cardiac Death in Moderated LVEF in ischEmic cardiomyopathY
Myocardial Infarction (MI), Sudden Cardiac Death Due to Cardiac Arrhythmia
RecruitingObservational study
Breisgau PHENO-HEART MI
Myocardial Infarction, STEMI
Enrolling by invitationPhase 3
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Acute Myocardial Infarction
Recruiting
CRP Apheresis in Infarct-Related Cardiogenic Shock
Cardiogenic Shock, Acute Myocardial Infarction (AMI)
Recruiting
Reducing Slow/No-Reflow With Prophylactic High-Dose Intracoronary Adenosine Protocol in ST-Elevation Myocardial Infarction The REFLOW AMI Trial
ST-Elevation Myocardial Infarction (STEMI)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One-Time Complete Revascularization and Staged Percutaneous Coronary Intervention in people with Myocardial Infarction and Coronary Artery Disease, run by Tanta 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 5 inclusion and 15 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 9 Apr 2026. 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?
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?
Total hospitalization time (time frame: up to 1 month post operatively). 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 9 Apr 2026.