Gradual Versus Abrupt Reperfusion in Primary PCI (GUARD)

NCT02732080 | Completed

• 1 other identifier: 373
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

After reopening of the infarct related artery by primary percutaneous coronary interventions (PPCI), microvascular damage at the related myocardial territory is not terminated immediately. This ongoing nature of microvascular damage leading to myocardial malperfusion is related to final infarct size. However, time course of the microvascular impairment /obstruction after PPCI in patients presented with ST-elevating acute myocardial infarction (STEMI) is not known. Routine primary percutaneous coronary interventions (PPCI) for ST-elevation acute myocardial infarction (STEMI) includes balloon angioplasty (or thrombectomy) followed immediately by stent implantation. However, stent implantation performed in this thrombotic setting may lead to a further microvascular damage by causing more distal embolisation and by inducing distal microvascular spasm by stretching the coronary vessel wall. Furthermore, sudden exposure of distal microcirculation to a high distal intracoronary pressure achieved by immediate stent implantation may exaggerate myocardial oedema which contributes microvascular damage substantially by external compression. However, results of studies investigating the efficacy of delayed stenting (24-48 hours later) in patients in whom TIMI -3 flow was achieved after balloon angioplasty were inconsistent. In this study, STEMI patients undergoing PPCI, in whom epicardial reperfusion was achieved (TIMI-3 flow) by wire crossing or by balloon angioplasty or aspiration thrombectomy, will be randomised to immediate and delayed stenting groups. Delayed stenting will be performed at the time when coronary auto regulation was recovered which is going to be determined based on the continuous intracoronary hemodynamic monitoring after reperfusion.

Conditions

ST-elevation Acute Myocardial Infarction

Keywords

primary percutaneous coronary intervention; microvascular obstruction; myocardial edema; microvascular resistance; acute myocardial infarction

Outcome Measures

Primary Outcomes (1)

• Coronary zero flow pressure (Pzf)

  At the end of the 1 hour intracoronary hemodynamic monitorization

Secondary Outcomes (1)

• Hyperemic microvascular resistance (HMR)

  At the end of the completion of 1 hour intracoronary hemodynamic monitorization

Study Arms (2)

Deferred coronary stenting

EXPERIMENTAL

In this arm, after establishing TIMI -3 flow in infarct related artery with balloon angioplasty, patients will undergo stent implantation when coronary autoregulatory function was recovered (initial hyperemic flow was subsided and baseline resistance was increased). Recovery of the auto regulatory function will be determined by measuring microvascular flow and resistance. After stenting microvascular flow / resistance will continue to be monitored using pressure/flow sensor tipped guide wire until the completion of 1 hour follow up period.

Device: deferred coronary stenting

Immediate stenting

ACTIVE COMPARATOR

In this arm, patients will undergo stenting immediately after balloon angioplasty. After stent implantation, microvascular flow / resistance values will be continuously monitored using pressure/flow sensor tipped guide wire until the end of 1 hour follow up period.

Device: immediate stenting

Interventions

deferred coronary stenting DEVICE

Final coronary stenting will be performed when coronary auto regulation was recovered (approximately 30 minutes after establishment of TIMI III flow şn the infarct related artery)

Deferred coronary stenting

immediate stenting DEVICE

Stent implantation will be performed immediately after balloon angioplasty (or thrombectomy or wire crossing) as it is performed in daily routine.

Immediate stenting

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting with ST-elevation acute myocardial infarction (STEMI) within 12 hours of their symptom onset in whom TIMI-3 flow was established in infarct related artery (IRA) after balloon angioplasty or thrombectomy.

You may not qualify if:

• Recanalized (TIMI I-III flow) IRA at coronary angiography.
• Patients in whom TIMI-3 flow was not able to be established after wire crossing, balloon angioplasty or thrombectomy.
• STEMI due to bypass-graft occlusion
• Severe heart failure or cardiogenic shock

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (2)

Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology

Istanbul, 34290, Turkey (Türkiye)

Location

Istanbul University School of Medicine

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

• Sezer M, Tas A, Demirtakan ZG, Broyd CJ, Ozcan A, Hasdemir H, Kocaaga M, Sezer I, Sonsoz MR, Atici A, Ozcan I, Umman B, Bugra Z, Davies JE, Escaned J, van Royen N, Umman S. Coronary microcirculation in nonculprit vessel territory in reperfused acute myocardial infarction. Microvasc Res. 2023 May;147:104495. doi: 10.1016/j.mvr.2023.104495. Epub 2023 Feb 3.

  PMID: 36739961 DERIVED

• Sezer M, Escaned J, Broyd CJ, Umman B, Bugra Z, Ozcan I, Sonsoz MR, Ozcan A, Atici A, Aslanger E, Sezer ZI, Davies JE, van Royen N, Umman S. Gradual Versus Abrupt Reperfusion During Primary Percutaneous Coronary Interventions in ST-Segment-Elevation Myocardial Infarction (GUARD). J Am Heart Assoc. 2022 May 17;11(10):e024172. doi: 10.1161/JAHA.121.024172. Epub 2022 May 16.

  PMID: 35574948 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: April 8, 2016
• Study Start: April 1, 2016
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: March 1, 2023

Record last verified: 2023-02

Locations

TU (2)