NCT04606459: COSIMA

COSIMA: COronary SInus Reducer for the Treatment of Refractory Microvascular Angina

Recruiting now NA Last updated 28 September 2023

What this trial tests

NA trial testing Coronary sinus reducer in Coronary Microvascular Disease in 144 participants. Currently enrolling.

Timeline

1 April 2021

Primary endpoint
20 October 2025

20 October 2029

Quick facts

Lead sponsor	Johannes Gutenberg University Mainz
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	144
Start date	1 April 2021
Primary completion	20 October 2025
Estimated completion	20 October 2029
Sites	1 location across Germany

Drugs / interventions tested

• Coronary sinus reducer
• Optimal medical therapy — full drug profile →

Conditions studied

• Coronary Microvascular Disease — all drugs for Coronary Microvascular Disease →
• Refractory Angina — all drugs for Refractory Angina →

Sponsor

Johannes Gutenberg University Mainz

Who can join

Adults 18 to 85, any sex, with Coronary Microvascular Disease or Refractory Angina. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients with refractory microvascular angina fulfilling the predefined inclusion and exclusion criteria will be enrolled in this randomized trial. The primary objective is to investigate whether the proportion of patients reporting an improvement in Canadian Cardiovascular Society (CCS) angina class (≥2 classes) is different at six months after implantation of a Coronary Sinus Reducer followed by optimal medical therapy (OMT) compared to OMT alone.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Ischemia and no obstructive coronary arteries (INOCA): A narrative review.
   Mehta PK, Huang J, Levit RD, Malas W, et al · · 2022 · cited 77× · PMID 36423427 · DOI 10.1016/j.atherosclerosis.2022.11.009
2. Coronary Arterial Function and Disease in Women With No Obstructive Coronary Arteries.
   Reynolds HR, Bairey Merz CN, Berry C, Samuel R, et al · · 2022 · cited 55× · PMID 35175840 · DOI 10.1161/circresaha.121.319892
3. The Efficacy of Coronary Sinus Reducer in Patients with Refractory Angina: A Systematic Review and Meta-Analysis.
   Theofilis P, Vlachakis PK, Sagris M, Mantzouranis E, et al · · 2024 · cited 6× · PMID 39076961 · DOI 10.31083/j.rcm2503082
4. Diseases of the Coronary Microcirculation: Diagnosis and Treatment.
   Ullrich-Daub H, Daub S, Olschewski M, Münzel T, et al · · 2023 · cited 5× · PMID 37721132 · DOI 10.3238/arztebl.m2023.0205
5. Focusing on microvascular function in heart failure with preserved ejection fraction.
   Velollari O, Rommel KP, Kresoja KP, Lurz P, et al · · 2025 · cited 4× · PMID 39804445 · DOI 10.1007/s10741-024-10479-7
6. Reappraising Ischemic Heart Disease in Women.
   Carberry J, Aubiniere-Robb L, Kamdar A, Lomholt-Welch H, et al · · 2023 · cited 3× · PMID 39076281 · DOI 10.31083/j.rcm2404118
7. Ischaemia with no obstructive coronary arteries: a review with focus on the Asian population.
   Soh RY, Low TT, Sia CH, Kong WK, et al · · 2024 · cited 3× · PMID 38973187 · DOI 10.4103/singaporemedj.smj-2023-116
8. Vasomotor Dysfunction in Patients with Ischemia and Non-Obstructive Coronary Artery Disease: Current Diagnostic and Therapeutic Strategies.
   Abouelnour A, Gori T. · · 2021 · cited 3× · PMID 34944590 · DOI 10.3390/biomedicines9121774