Pre-conditioning by Balloon-inflation on Myocardial Injury

NCT05149846 | Withdrawn

• 1 other identifier: BaMI
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study objectives: To test pre-conditioning by three consecutive 60 seconds balloon inflations, spaced 120 seconds apart, followed by 10 minutes rest prior to PCI reduces the risk of myocardial injury. Study design: Single-center, open-label, randomized controlled trial Study population: Patients with indication for complex PCI. Patients will be randomized prior to PCI to pre-conditioning by intracoronary balloon inflation in the target vessel proximal to the target lesion(s) versus no pre-conditioning followed by a 10-minute waiting period prior to PCI. PCI will then be performed as per standard of care. Cardiac biomarkers will be drawn at baseline and 6, 24 and 48 hours after PCI. Cardiac magnetic resonance imaging will be performed at 48 hours and 6 months post PCI.

Conditions

Myocardial Ischemia

Outcome Measures

Primary Outcomes (3)

• Cardiac troponin-I

  Area-under the curve of cardiac troponin-I

  within 48 hours

• Infarct size

  Procedural infarct size as assessed by cardiac magnetic resonance imaging

  48 hours

• Infarct size

  Procedural infarct size as assessed by cardiac magnetic resonance imaging

  6 months

Study Arms (2)

Pre-conditioning

OTHER

Pre-conditioning by three consecutive 60 seconds balloon inflations, spaced 120 seconds apart followed by 10 minutes rest prior to PCI

Procedure: Pre-conditioning

Controll

NO INTERVENTION

No pre-conditioning, standard care

Interventions

Pre-conditioning PROCEDURE

Pre-conditioning by three consecutive 60 seconds balloon inflations, spaced 120 seconds apart followed by 10 minutes rest prior to PCI

Pre-conditioning

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years.
• Indication for complex PCI, defined as:
• PCI of a chronic total occlusion
• Two-stent PCI of a bifurcation lesion.
• PCI of severely calcified lesion
• Preprocedural biomarker Troponin-I within normal range
• Left ventricular ejection fraction \>50%
• Written informed consent obtained

You may not qualify if:

• Previous randomization in the study
• Decompensated heart failure requiring inotropic /adrenergic support, invasive or non-invasive ventilation or intra-aortic balloon pump/ventricular assist device therapy less than 48 hours prior to randomization
• Recent PCI (\<3 months)
• Known previous myocardial infarction in the target vessel or regional wall motion abnormalities within the myocardium subtended by the target vessel(s)
• Any contraindication for Cardiac magnetic resonance imaging
• Pregnancy

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Sahlgrenska University Hospital: collaborator

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Björn Redfors, MD, PhD

  Vastra Gotaland Region

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: December 8, 2021
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 17, 2024

Record last verified: 2021-11