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Completed

NCT Number: NCT07519590

One-Time Complete Revascularization Versus Staged PCI in MVD 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.

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Key information

Conditions

Myocardial Infarction Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helwan University Hospital

Cairo, Cairo Governorate, 11795, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

One-Time Complete Revascularization

Procedure

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 Intervention

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Total expenses

    Time frame: up to 1 month post operatively

    Total treatment-related expenses in Egyptian pounds for the index admission and, when applicable, the staged admission.

  2. Contrast-induced nephropathy

    Time frame: Within 72 hours after percutaneous coronary intervention

    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.

  3. Angina-related hospitalization

    Time frame: Within 3 months after index percutaneous coronary intervention

    Hospital admission due to recurrent anginal symptoms during follow-up.

  4. Left ventricular ejection fraction

    Time frame: Baseline and 3 months after index percutaneous coronary intervention

    Left ventricular systolic function assessed by transthoracic echocardiography using the modified Simpson method.

  5. Wall motion score index

    Time frame: Baseline and 3 months after index percutaneous coronary intervention

    Regional left ventricular wall motion score index assessed by transthoracic echocardiography.

  6. Serum creatinine

    Time frame: Baseline, 72 hours after percutaneous coronary intervention, and 3 months

    Serum creatinine concentration measured to assess renal function.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Collaborators

  • Helwan University

Registry information

Official study title

One Time Complete Revascularization Versus Staged PCI in Multivessel Coronary Artery Disease During Pharmaco Invasive STEMI Strategy

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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