New Three-dimensional Methods of Analysis for the Detection of Coronary Artery Disease by Dobutamine Stress Echocardiography

NCT02240745 | Completed DMC

• 2 other identifiers: 039/14SNCTP 0761
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are going to recruit patients who have a scheduled elective coronary angiography and going to do a dobutamin stress echography (DSE) before the coronary examination. Next to a regular 2D-DSE, the investigators will perform an 3-dimensional DSE, incl ventriculography. In the interventional part (coronary angiography), they will measure each stenosis with fractional flow-reserve (FFR)and herewith graduate its stenosis severity.

Conditions

Coronary Artery Disease; Echocardiography, Stress

Keywords

Echocardiography, Stress; Echocardiography, Three-Dimensional; Coronary Artery Disease; Fractional Flow Reserve, Myocardial; Coronary Circulation

Outcome Measures

Primary Outcomes (1)

• Area Strain in the affected coronary artery stenosis myocardial segments (Reference: Coronary flow reserve CFR)

  Area Strain (%) by Echocardiography

  After dobutamin-stress-echocardiography, PTCA will be performed within aprox.1-3hours

Secondary Outcomes (1)

• Area at Risk: Surface Area of site with reduced strain relative to the total LV-surface

  After dobutamin-stress-echocardiography, PTCA will be performed within aprox.1-3hours

Study Arms (1)

All patients

Patients with a suspicion of coronary heart disease

Other: Stress-echocardiography

Interventions

Stress-echocardiography OTHER

Stress-echocardiography (incl dobutamin and atropin)

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

100 consecutive subjects referred to the Department of Cardiology for elective coronary angiography.

You may qualify if:

• Scheduled elective coronary angiography
• Age \>/= 18 years
• Written informed consent

You may not qualify if:

• Age \< 18 years
• Acute coronary syndrome
• Unstable angina pectoris
• Coronary 3-vessel disease
• Left-main artery affected
• Situation after myocardial infarction
• Coronary anomaly
• Situation after coronary bypass
• Congenital heart disease
• Pacemaker
• Any contraindication concerning stress-echo

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Dept of Cardiology, Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (5)

• Task Force Members; Montalescot G, Sechtem U, Achenbach S, Andreotti F, Arden C, Budaj A, Bugiardini R, Crea F, Cuisset T, Di Mario C, Ferreira JR, Gersh BJ, Gitt AK, Hulot JS, Marx N, Opie LH, Pfisterer M, Prescott E, Ruschitzka F, Sabate M, Senior R, Taggart DP, van der Wall EE, Vrints CJ; ESC Committee for Practice Guidelines; Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers; Knuuti J, Valgimigli M, Bueno H, Claeys MJ, Donner-Banzhoff N, Erol C, Frank H, Funck-Brentano C, Gaemperli O, Gonzalez-Juanatey JR, Hamilos M, Hasdai D, Husted S, James SK, Kervinen K, Kolh P, Kristensen SD, Lancellotti P, Maggioni AP, Piepoli MF, Pries AR, Romeo F, Ryden L, Simoons ML, Sirnes PA, Steg PG, Timmis A, Wijns W, Windecker S, Yildirir A, Zamorano JL. 2013 ESC guidelines on the management of stable coronary artery disease: the Task Force on the management of stable coronary artery disease of the European Society of Cardiology. Eur Heart J. 2013 Oct;34(38):2949-3003. doi: 10.1093/eurheartj/eht296. Epub 2013 Aug 30. No abstract available.

  PMID: 23996286 BACKGROUND

• Doucette JW, Corl PD, Payne HM, Flynn AE, Goto M, Nassi M, Segal J. Validation of a Doppler guide wire for intravascular measurement of coronary artery flow velocity. Circulation. 1992 May;85(5):1899-911. doi: 10.1161/01.cir.85.5.1899.

  PMID: 1572046 BACKGROUND

• Traupe T, Gloekler S, de Marchi SF, Werner GS, Seiler C. Assessment of the human coronary collateral circulation. Circulation. 2010 Sep 21;122(12):1210-20. doi: 10.1161/CIRCULATIONAHA.109.930651. No abstract available.

  PMID: 20855668 BACKGROUND

• Meuwissen M, Siebes M, Chamuleau SA, Tijssen JG, Spaan JA, Piek JJ. Intracoronary pressure and flow velocity for hemodynamic evaluation of coronary stenoses. Expert Rev Cardiovasc Ther. 2003 Sep;1(3):471-9. doi: 10.1586/14779072.1.3.471.

  PMID: 15030274 BACKGROUND

• Varga A, Garcia MA, Picano E; International Stress Echo Complication Registry. Safety of stress echocardiography (from the International Stress Echo Complication Registry). Am J Cardiol. 2006 Aug 15;98(4):541-3. doi: 10.1016/j.amjcard.2006.02.064. Epub 2006 Jun 28.

  PMID: 16893714 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Stefano de Marchi, Senior consultant

  Dept. of Cardiology, University Hospital of Bern, Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2014
• First Posted: September 16, 2014
• Study Start: November 30, 2014
• Primary Completion: November 30, 2016
• Study Completion: November 30, 2016
• Last Updated: March 28, 2023

Record last verified: 2023-03

Locations

CH (1)