Coronary Thermo-dilution Derived Flow-indices in Chronic Coronary Syndrome

NCT06306066 | Completed

• 1 other identifier: 2015/962-31
• Study Type: observational
• Target: 505
• Locations: 1 country
• Sites: 1

Brief Summary

Patients scheduled for elective coronary angiography due to chronic coronary syndrome are recruited at admission to hospital before the coronary anatomy is known. Immediately after coronary angiography measures thermo-dilution derived flow indices are obtained in the left left anterior descending artery (LAD). The patients are followed through telephone-calls and medical records at 1 and 2 years after inclusion and at completion of the study. The hypothesis is that elevated index of microcirculatory resistance (IMR),(\>25) is associated with all-cause death, myocardial infarction (MI) and hospitalization due to congestive heart failure (CHF). The primary analysis is the relationship between IMR and the composite outcome all-cause death, MI and hospitalization due to CHF.

Conditions

Coronary Artery Disease; Microvascular Angina; Coronary Microvascular Dysfunction

Keywords

coronary microvascular dysfunction; microvascular angina; coronary artery disease; microcirculation; index of microcirculatory dysfunction; coronary flow reserve; baseline resistance index

Outcome Measures

Primary Outcomes (1)

• Rate of all-cause mortality, MI and/or hospitalization due to CHF

  Cumulative rate of all-cause mortality, MI and/or hospitalization due to CHF at study completion

  Study completion, approximately 5 years

Secondary Outcomes (7)

• Rate of all-cause mortality

  Study completion, approximately 5 years

• Rate of hospitalization due to CHF.

  Study completion, approximately 5 years

• Rate of all-cause mortality and/or MI

  Study completion, approximately 5 years

• Rate of MI

  Study completion, approximately 5 years

• Rate of stroke

  Study completion, approximately 5 years

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with stable angina pectoris or suspected angina pectoris who are scheduled for coronary angiography

You may qualify if:

• Subjects with stable angina pectoris or suspected angina pectoris who are scheduled for coronary angiography
• Age 18 years - 85 years
• Life expectancy \>2 years

You may not qualify if:

• Acute coronary syndrome (ST-elevation myocardial infarction \[STEMI\], non-ST-elevation myocardial infarction \[NSTEMI\] and unstable angina pectoris)
• Known CHF
• Prior heart transplantation
• Prior coronary artery by-pass grafting
• Hypertrophic cardiomyopathy (Septum \>15 mm)
• Valvular disease
• Not eligible for coronary angiogram
• Cancer within three years of admission
• Peri-myocarditis
• Atrial fibrillation with heart beats per minute \>120
• Asthma

Sponsors & Collaborators

• Karolinska Institutet: lead
• Abbott: collaborator

Study Sites (1)

Danderyd University Hospital and Karolinska Institutet Danderyds University Hospital (KI DS)

Stockholm, 182 88, Sweden

Location

Related Publications (16)

• Knuuti J, Wijns W, Saraste A, Capodanno D, Barbato E, Funck-Brentano C, Prescott E, Storey RF, Deaton C, Cuisset T, Agewall S, Dickstein K, Edvardsen T, Escaned J, Gersh BJ, Svitil P, Gilard M, Hasdai D, Hatala R, Mahfoud F, Masip J, Muneretto C, Valgimigli M, Achenbach S, Bax JJ; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020 Jan 14;41(3):407-477. doi: 10.1093/eurheartj/ehz425. No abstract available.

  PMID: 31504439 BACKGROUND

• Murthy VL, Naya M, Foster CR, Gaber M, Hainer J, Klein J, Dorbala S, Blankstein R, Di Carli MF. Association between coronary vascular dysfunction and cardiac mortality in patients with and without diabetes mellitus. Circulation. 2012 Oct 9;126(15):1858-68. doi: 10.1161/CIRCULATIONAHA.112.120402. Epub 2012 Aug 23.

  PMID: 22919001 BACKGROUND

• Ong P, Camici PG, Beltrame JF, Crea F, Shimokawa H, Sechtem U, Kaski JC, Bairey Merz CN; Coronary Vasomotion Disorders International Study Group (COVADIS). International standardization of diagnostic criteria for microvascular angina. Int J Cardiol. 2018 Jan 1;250:16-20. doi: 10.1016/j.ijcard.2017.08.068. Epub 2017 Sep 8.

  PMID: 29031990 BACKGROUND

• Ford TJ, Stanley B, Good R, Rocchiccioli P, McEntegart M, Watkins S, Eteiba H, Shaukat A, Lindsay M, Robertson K, Hood S, McGeoch R, McDade R, Yii E, Sidik N, McCartney P, Corcoran D, Collison D, Rush C, McConnachie A, Touyz RM, Oldroyd KG, Berry C. Stratified Medical Therapy Using Invasive Coronary Function Testing in Angina: The CorMicA Trial. J Am Coll Cardiol. 2018 Dec 11;72(23 Pt A):2841-2855. doi: 10.1016/j.jacc.2018.09.006. Epub 2018 Sep 25.

  PMID: 30266608 BACKGROUND

• van de Hoef TP, Bax M, Damman P, Delewi R, Hassell ME, Piek MA, Chamuleau SA, Voskuil M, van Eck-Smit BL, Verberne HJ, Henriques JP, Koch KT, de Winter RJ, Tijssen JG, Piek JJ, Meuwissen M. Impaired Coronary Autoregulation Is Associated With Long-term Fatal Events in Patients With Stable Coronary Artery Disease. Circ Cardiovasc Interv. 2013 Aug;6(4):329-35. doi: 10.1161/CIRCINTERVENTIONS.113.000378. Epub 2013 Jul 30.

  PMID: 23899871 BACKGROUND

• Lee JM, Jung JH, Hwang D, Park J, Fan Y, Na SH, Doh JH, Nam CW, Shin ES, Koo BK. Coronary Flow Reserve and Microcirculatory Resistance in Patients With Intermediate Coronary Stenosis. J Am Coll Cardiol. 2016 Mar 15;67(10):1158-1169. doi: 10.1016/j.jacc.2015.12.053.

  PMID: 26965536 BACKGROUND

• Crea F, Bairey Merz CN, Beltrame JF, Kaski JC, Ogawa H, Ong P, Sechtem U, Shimokawa H, Camici PG; Coronary Vasomotion Disorders International Study Group (COVADIS). The parallel tales of microvascular angina and heart failure with preserved ejection fraction: a paradigm shift. Eur Heart J. 2017 Feb 14;38(7):473-477. doi: 10.1093/eurheartj/ehw461. No abstract available.

  PMID: 27907892 BACKGROUND

• Ostlund-Papadogeorgos N, Ekenback C, Jokhaji F, Mir-Akbari H, Witt N, Jernberg T, Wallen H, Linder R, Tornerud M, Samad BA, Persson J. Blood haemoglobin, renal insufficiency, fractional flow reserve and plasma NT-proBNP is associated with index of microcirculatory resistance in chronic coronary syndrome. Int J Cardiol. 2020 Oct 15;317:1-6. doi: 10.1016/j.ijcard.2020.05.037. Epub 2020 May 25.

  PMID: 32464253 BACKGROUND

• Jespersen L, Hvelplund A, Abildstrom SZ, Pedersen F, Galatius S, Madsen JK, Jorgensen E, Kelbaek H, Prescott E. Stable angina pectoris with no obstructive coronary artery disease is associated with increased risks of major adverse cardiovascular events. Eur Heart J. 2012 Mar;33(6):734-44. doi: 10.1093/eurheartj/ehr331. Epub 2011 Sep 11.

  PMID: 21911339 BACKGROUND

• De Bruyne B, Pijls NH, Smith L, Wievegg M, Heyndrickx GR. Coronary thermodilution to assess flow reserve: experimental validation. Circulation. 2001 Oct 23;104(17):2003-6. doi: 10.1161/hc4201.099223.

  PMID: 11673336 BACKGROUND

• Fearon WF, Balsam LB, Farouque HM, Caffarelli AD, Robbins RC, Fitzgerald PJ, Yock PG, Yeung AC. Novel index for invasively assessing the coronary microcirculation. Circulation. 2003 Jul 1;107(25):3129-32. doi: 10.1161/01.CIR.0000080700.98607.D1. Epub 2003 Jun 23.

  PMID: 12821539 BACKGROUND

• Aarnoudse W, Fearon WF, Manoharan G, Geven M, van de Vosse F, Rutten M, De Bruyne B, Pijls NH. Epicardial stenosis severity does not affect minimal microcirculatory resistance. Circulation. 2004 Oct 12;110(15):2137-42. doi: 10.1161/01.CIR.0000143893.18451.0E. Epub 2004 Oct 4.

  PMID: 15466646 BACKGROUND

• Fearon WF, Aarnoudse W, Pijls NH, De Bruyne B, Balsam LB, Cooke DT, Robbins RC, Fitzgerald PJ, Yeung AC, Yock PG. Microvascular resistance is not influenced by epicardial coronary artery stenosis severity: experimental validation. Circulation. 2004 May 18;109(19):2269-72. doi: 10.1161/01.CIR.0000128669.99355.CB. Epub 2004 May 10.

  PMID: 15136503 BACKGROUND

• Fearon WF, Low AF, Yong AS, McGeoch R, Berry C, Shah MG, Ho MY, Kim HS, Loh JP, Oldroyd KG. Prognostic value of the Index of Microcirculatory Resistance measured after primary percutaneous coronary intervention. Circulation. 2013 Jun 18;127(24):2436-41. doi: 10.1161/CIRCULATIONAHA.112.000298. Epub 2013 May 16.

  PMID: 23681066 BACKGROUND

• Yong AS, Layland J, Fearon WF, Ho M, Shah MG, Daniels D, Whitbourn R, Macisaac A, Kritharides L, Wilson A, Ng MK. Calculation of the index of microcirculatory resistance without coronary wedge pressure measurement in the presence of epicardial stenosis. JACC Cardiovasc Interv. 2013 Jan;6(1):53-8. doi: 10.1016/j.jcin.2012.08.019.

  PMID: 23347861 BACKGROUND

• Shekarestan S, Jokhaji F, Ekenback C, Tornerud M, Lorstad S, Ljungman P, Ostlund-Papadogeorgos N, Linder R, Samad B, Persson J. Elevated Resting Coronary Blood Flow Is Associated With Death, MI, and HF in All-Comer Patients With Chronic Coronary Syndrome. Circ Cardiovasc Interv. 2026 Jan 15:e015867. doi: 10.1161/CIRCINTERVENTIONS.125.015867. Online ahead of print.

  PMID: 41537270 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Plasma samples and whole blood obtained at index coronary angiography

MeSH Terms

Conditions

Coronary Artery Disease; Microvascular Angina

Condition Hierarchy (Ancestors)

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

Study Officials

• JONAS PERSSON, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, MD, PhD

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 12, 2024
• Study Start: September 2, 2015
• Primary Completion: June 7, 2021
• Study Completion: December 28, 2022
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)