Pre-conditioning by Balloon-inflation on Myocardial Injury

NCT ID: NCT05149846

Last Updated: 2024-05-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-12-31

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.

Detailed Description

The primary objective of this study is to test pre-conditioning by three consecutive 60 seconds balloon inflations, spaced 120 seconds apart followed by 10 minutes rest prior to percutaneous coronary intervention (PCI) reduces the risk of myocardial injury.

Except for the extended duration of balloon inflations, no study-specific therapy will be administered to the patients. All patients will receive treatment according to current guidelines. A follow-up visit will be performed at approximately 6, 24, 48 hours and at 6 months.

The population studied are patients with indication for complex PCI. Patients will be randomized, after providing written informed consent, prior to PCI to pre-conditioning by three consecutive 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 hours, 24 hours and 48 hours after PCI. Cardiac magnetic resonance imaging will be performed at 48 hours and 6 months post PCI.

Three consecutive balloon occlusions performed for approximate 60 seconds and spaced approximate 120 seconds apart, followed by a 10-minute waiting period prior to PCI.

Cardiac Magnetic Resonance imaging (CMR) will be used to assess size of myocardial infarction at 48±6 hours and 6 months±30 days post PCI. CMR examination includes administration of contrast and one additional blood test (hematocrit, necessary to assess extracellular volume).

Echocardiography can be used before randomization as per standard of care before PCI. Echocardiography will be used to assess wall motion score index, left ventricular ejection fraction at 24 hours and serial examinations can be performed at the discretion of the PI 12-lead Electrocardiogram (ECG) will be used to assess at baseline, during intervention, at 48 hours and serial examinations can be performed at the discretion of the PI.

Apart from the routine laboratory tests, blood samples (troponin-I, troponin-T, creatine kinase MB fraction [CKMB]) will be collected at baseline, 6±1 hour, 24±6 hours 48±6 hours after PCI. After collection blood samples will be analyzed at hospitals clinical laboratory and destructed directly after analyses.

Conditions

Myocardial Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pre-conditioning

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

Group Type: OTHER

Pre-conditioning

Intervention Type: PROCEDURE

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

Controll

No pre-conditioning, standard care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pre-conditioning

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years.

2. Indication for complex PCI, defined as:

1. PCI of a chronic total occlusion

2. Two-stent PCI of a bifurcation lesion.

3. PCI of severely calcified lesion

3. Preprocedural biomarker Troponin-I within normal range

4. Left ventricular ejection fraction >50%

5. Written informed consent obtained

Exclusion Criteria

1. Previous randomization in the study

2. 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

3. Recent PCI (<3 months)

4. Known previous myocardial infarction in the target vessel or regional wall motion abnormalities within the myocardium subtended by the target vessel(s)

5. Any contraindication for Cardiac magnetic resonance imaging

6. Pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sahlgrenska University Hospital

OTHER

Sponsor Role: collaborator

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Björn Redfors, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Vastra Gotaland Region

Other Identifiers

BaMI

Identifier Type: -

Identifier Source: org_study_id