Analysis of Myocardial Layer Specific Systolic and Diastolic Function During and After PCI

NCT ID: NCT02004483

Last Updated: 2015-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2014-12-31

Brief Summary

Investigators will analyzed systolic and diastolic function during and after ischemia induced by percutaneous coronary intervention.Also will be analyzed a local work index during acute ischemia induced by percutaneous coronary intervention.

Detailed Description

PART 1: ANALYSIS OF LAYER SPECIFIC SYSTOLIC AND DIASTOLIC FUNCTION DURING ACUTE ISCHEMIA INDUCED BY PERCUTANEOUS CORONARY INTERVENTION 35 patients with normal systolic left ventricular function at baseline with indication for elective percutaneous coronary angioplasty will be included in the study. In these patients acute ischemia will be induced by elective percutaneous coronary angioplasty with balloon inflation and thus vessel occlusion for 60 sec. During these 60 seconds ischemia will develop throughout all layers of the myocardium affecting diastolic systolic and diastolic function. During the subsequent reperfusion period signs of ischemia with systolic and diastolic dysfunction of all layers will subside. Echocardiographic imaging at short intervals of 10 sec during ischemia and at intervals of 20 sec during reperfusion up to 10 min after reopening of the vessel as well as 1 hour and 24 hours later will allow serial comparison of strain curves and thereby allow definition of the time sequence systolic and diastolic function abnormalities occur in three myocardial layers as well as the resolution of abnormalities during reperfusion. The analysis of circumferential as well as radial strain will allow definition of differences between radial and circumferential strain during ischemia induction and resolution.

PART 2: ANALYSIS OF LOCAL WORK INDEX DURING ACUTE ISCHEMIA INDUCED BY PERCUTANEOUS CORONARY INTERVENTION.

In the same 35 patients as in Clinical step 1 the local work index of the ischemic area as well as the contralateral non-ischemic areas will be determined in serial studies to determine the onset of abnormality, the amount of abnormality and the resolution of abnormality. Changes in local work index in the ischemic area will be related to changes in peak systolic strain and strain imaging diastolic index.

Conditions

Percutaneous Coronary Intervention; Myocardial Ischemia; Anginal Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Percutaneous Coronary Intervention

Each patient will get elective percutaneous coronary angioplasty with balloon inflation(PCI). During and after PCI 2D-echography (strain) will be performed.

Group Type: EXPERIMENTAL

Percutaneous Coronary Intervention

Intervention Type: PROCEDURE

Percutaneous coronary intervention is performed according to standard practice. Direct stenting is required for the procedure as it is done in most coronary interventions today. After insertion of the non-inflated stent into the coronary lesion there should still be flow to the distal vessel. The stent should be implanted at high-pressure with balloon inflation lasting for 60 seconds to allow adequate expansion of the stent. Post-dilatation should be performed if required. However, this should be done more than 5 minutes after stent implantation.

Interventions

Percutaneous Coronary Intervention

Percutaneous coronary intervention is performed according to standard practice. Direct stenting is required for the procedure as it is done in most coronary interventions today. After insertion of the non-inflated stent into the coronary lesion there should still be flow to the distal vessel. The stent should be implanted at high-pressure with balloon inflation lasting for 60 seconds to allow adequate expansion of the stent. Post-dilatation should be performed if required. However, this should be done more than 5 minutes after stent implantation.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Signed informed consent.
• Adequate quality of echocardiographic images.
• Significant stenosis of the proximal left anterior descending artery, the right coronary artery or the left circumflex artery
• Anginal pain or proven myocardial ischemia due to the coronary stenosis
• Elective percutaneous coronary intervention planned
• Planned direct stenting of the coronary artery

Exclusion Criteria

• Prior myocardial infarction
• Significant coronary collaterals
• Significant valvular regurgitation (>Sellers II)
• Congestive heart failure
• Pacemaker dependency
• Bundle branch block or significant arrhythmia
• Atrial fibrillation
• Previous coronary bypass grafting
• Impaired kidney function corresponding to a GFR(Glomerular filtration rate) below 60 mL/min.
• Women, who are pregnant or breastfeeding.
• Patient taking part in another clinical study
• Subjects who are committed to an institution and/or penitentiary by judicial or official order.
• Complex coronary lesion requiring balloon angioplasty or rotational atherectomy prior to stenting

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Department of Biomedical Engineering, Technion, Haifa, Israel

UNKNOWN

Sponsor Role: collaborator

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rainer Hoffmann, Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

RWTH Aachen University Hospital

Locations

University Hospital Aachen

Aachen, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

032/10

Identifier Type: OTHER

Identifier Source: secondary_id

10-091

Identifier Type: -

Identifier Source: org_study_id