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

NCT02004483 | Completed

• 2 other identifiers: 10-091032/10
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Percutaneous Coronary Intervention; Myocardial Ischemia; Anginal Pain

Keywords

percutaneous coronary intervention; ischemia; strain; coronary stenosis

Outcome Measures

Primary Outcomes (1)

• systolic and diastolic function

  Echocardiographic imaging at short intervals of 10 sec during ischemia, which will be induced by elective percutaneous coronary angioplasty with balloon inflation and thus vessel occlusion for 60 sec.

  during 60 seconds ischemia caused by PCI

Secondary Outcomes (1)

• systolic and diastolic function

  during 10 minutes, after 1 hour and after 24 hours after PCI

Study Arms (1)

Percutaneous Coronary Intervention

EXPERIMENTAL

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

Procedure: Percutaneous Coronary Intervention

Interventions

Percutaneous Coronary Intervention 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.

Percutaneous Coronary Intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RWTH Aachen University: lead
• Department of Biomedical Engineering, Technion, Haifa, Israel: collaborator

Study Sites (1)

University Hospital Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

MeSH Terms

Conditions

Myocardial Ischemia; Angina Pectoris; Ischemia; Sprains and Strains; Coronary Stenosis

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Wounds and Injuries; Coronary Disease

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Rainer Hoffmann, Prof.Dr.

  RWTH Aachen University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2013
• First Posted: December 9, 2013
• Study Start: August 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 23, 2015

Record last verified: 2015-09

Locations

DE (1)