NCT06393478

Brief Summary

SATURATION is a prospective multicenter registry of consecutive patients who undergo coronary physiology testing using Pressure Wire X and Coroflow Coroventis Cardiovascular System software (Abbott Vascular, Abbott Park, IL, USA) and to assess the regional practice of patient selection, cardiovascular outcomes and additional procedures (stress testing, angiography, etc.) done after comprehensive invasive coronary physiology evaluation.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
95mo left

Started Mar 2024

Longer than P75 for all trials

Geographic Reach
5 countries

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Mar 2024Mar 2034

Study Start

First participant enrolled

March 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 1, 2024

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2034

Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

5 years

First QC Date

April 26, 2024

Last Update Submit

May 12, 2024

Conditions

Keywords

microvascular angina, thermodilution, coronary flow reserve

Outcome Measures

Primary Outcomes (2)

  • all-cause death and non-fatal MI

    The study will record aggregate number of participants that died and/or suffered from myocardial infarction after invasive physiology procedure

    5 years

  • composite MACE

    The study will record aggregate number of participants that died from any cause and/or experienced non-fatal myocardial infarction and/or coronary angioplasty procedure and/or hospitalization for cardiovascular causes (acute coronary syndrome, heart failure, angina, repeated coronary angiography)

    5 years

Secondary Outcomes (8)

  • all-cause death

    5 years

  • cardiovascular death

    5 years

  • myocardial infarction

    5 years

  • coronary revascularization

    5 years

  • stroke

    5 years

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients suffering from angina who undergo coronary physiology testing using Pressure Wire X and Coroflow Coroventis Cardiovascular System software (Abbott Vascular, Abbott Park, IL, USA).

You may qualify if:

  • Adults of both sexes older than 18 years
  • Angina symptoms or angina equivalent
  • Referred to Cath lab for evaluation of CAD
  • Invasive physiology testing performed (microcirculation testing +/- vasospasm testing) using Coroflow Coroventis Cardiovascular system (Abbott Vascular, Abbott Park, IL, USA)

You may not qualify if:

  • Persons under the age of 18
  • Pregnant of nursing
  • No coronary physiology measurements performed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

CHC Rijeka

Rijeka, Croatia

NOT YET RECRUITING

KBC Zagreb

Zagreb, Croatia

NOT YET RECRUITING

MITERA General Hospital

Athens, 15123, Greece

RECRUITING

Hippokration Hospital

Athens, Greece

RECRUITING

Heraklion University Hospital

Heraklion, Greece

RECRUITING

University Hospital of Patras

Pátrai, Greece

RECRUITING

Tel Aviv Sourasky MC

Tel Aviv, Israel

NOT YET RECRUITING

Institute for cardiovascular diseases Dedinje

Belgrade, 11040, Serbia

RECRUITING

Institute for cardiovascular diseases Vojvodine

Novi Sad, 21000, Serbia

RECRUITING

UMC Ljubljana

Ljubljana, Slovenia

NOT YET RECRUITING

MeSH Terms

Conditions

Microvascular AnginaCoronary Artery Disease

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Central Study Contacts

Ivan S Ilić, MD, PhD

CONTACT

Natalija Odanovic, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 26, 2024

First Posted

May 1, 2024

Study Start

March 1, 2024

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2034

Last Updated

May 14, 2024

Record last verified: 2024-05

Locations