NCT04131075

Brief Summary

This is a prospective cohort blinded study with the aim to investigate the prevalence and clinical impact of coronary microcirculatory dysfunction (CMD) in patients with ischemic heart disease, and its association with cerebral small vessel disease (CSVD) and depressive disorders. In addition, CMD and CSVD linkage to systemic inflammation and endothelial function will also be investigated.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

March 1, 2017

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

January 6, 2020

Status Verified

January 1, 2020

Enrollment Period

2.8 years

First QC Date

October 16, 2019

Last Update Submit

January 2, 2020

Conditions

Ischemic Heart DiseaseMicrovascular Coronary Artery DiseaseDepressionEndothelial DysfunctionInflammation

Keywords

Coronary microvascular dysfunctionCerebral Small Vessel Diseases

Outcome Measures

Primary Outcomes (5)

  • Incidence of Major Cardiovascular Events (MACE): all-cause of death, myocardial infarction and any type of coronary revascularization

    Clinical assessment

    1 month

  • Incidence of Major Cardiovascular Events (MACE): all-cause of death, myocardial infarction and any type of coronary revascularization

    Clinical assessment.

    6 months

  • Incidence of Major Cardiovascular Events (MACE): all-cause of death, myocardial infarction and any type of coronary revascularization

    Clinical assessment.

    1 year

  • Prevalence of Cerebral Small Vessel Disease (CSVD).

    Determined by Cerebral MRI, transcranial Doppler Ultrasound and clinical assessment.

    Baseline

  • Prevalence of Cerebral Small Vessel Disease (CSVD).

    Determined by Cerebral MRI, transcranial Doppler Ultrasound and clinical assessment.

    1 year

Secondary Outcomes (10)

  • Assessment of angina status by Seattle Angina Questionnaire (SAQ)

    1 month

  • Assessment of angina status by Seattle Angina Questionnaire (SAQ)

    6 months

  • Assessment of angina status by Seattle Angina Questionnaire (SAQ)

    1 year

  • Prevalence of depressive and anxiety disorders, determined by clinical assessment and dedicated questionnaires.

    1 month

  • Prevalence of depressive and anxiety disorders, determined by clinical assessment and dedicated questionnaires.

    6 months

  • +5 more secondary outcomes

Study Arms (1)

Study group

Patients with CAD undergoing FFR-guided revascularisation. FFR, coronary flow reserve (CFR) and the index of hyperemic microvascular resistance (HMR) will be measured with the Doppler guidewire (Combowire, Volcano - Philips corporation) under steady state hyperemia.

Procedure: Coronary Angiography and Multimodal Coronary Physiology Study (FFR, CFR, HMR)

Interventions

Coronary Angiography and Multimodal Coronary Physiology Study (FFR, CFR, HMR)PROCEDURE

Coronary Angiography according to clinical indication and Multimodal Coronary Physiology Study (FFR, CFR, HMR) for functional assessment of intermediate coronary lesions

Study group

Eligibility Criteria

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

Patients with stable coronary lesions (stable coronary disease or lesions in non-culprit vessels \>48 hours after acute coronary syndrome) with clinical indication to coronary angiography and intermediate coronary lesions (visual estimation) suitable for FFR-guided revascularization.

You may qualify if:

  • Informed Consent available.
  • Age ≥ 18 years.
  • Stable coronary lesions.
  • Indication to FFR: ≥ 1 intermediate coronary lesion (40-80% diameter stenosis) in a principal/secondary vessel with ≥ 2 mm reference diameter.

You may not qualify if:

  • Previous myocardial infarction in the territory of distribution of the target vessel.
  • Coronary Left Main severe stenosis.
  • Aortic valve stenosis (moderate or severe) .
  • Severe left ventricle hypertrophy.
  • Left ventricle moderate systolic dysfunction (EF \< 35%).
  • Contraindications to adenosine.
  • Previous CABG with permeable grafts.
  • Contraindication to stent implantation.
  • Severe anemia.
  • Coagulopathies or chronic anticoagulation.
  • Platelets \< 75000 o \> 700.000.
  • Previous stroke or intracranial hemorrhage.
  • Contraindication to MRI.
  • Chronic Renal Failure contraindicating gadolinium infusion during MRI: eGFR \< 60 ml/min), hemodialysis, previous renal transplantation.
  • Pacemaker/ Implantable Cardioverter Device with contraindication to MRI.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínico San Carlos

Madrid, 28040, Spain

RECRUITING

Related Publications (1)

  • Mejia-Renteria H, Travieso A, Matias-Guiu JA, Yus M, Espejo-Paeres C, Finocchiaro F, Fernandez S, Gomez-Escalonilla CI, Reneses-Prieto B, Gomez-Garre MD, Delgado-Alvarez A, Bustos A, Perez de Isla L, de Diego JJG, Modrego-Martin J, Ortega-Hernandez A, Papadopoulos P, Arrazola-Garcia J, Matias-Guiu J, Escaned J. Coronary microvascular dysfunction is associated with impaired cognitive function: the Cerebral-Coronary Connection study (C3 study). Eur Heart J. 2023 Jan 7;44(2):113-125. doi: 10.1093/eurheartj/ehac521.

    PMID: 36337036DERIVED

MeSH Terms

Conditions

Myocardial IschemiaDepressionInflammationCerebral Small Vessel Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesBehavioral SymptomsBehaviorPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Javier Escaned, MD, PhD

    Instituto Carlos III. Hospital Clínico San Carlos.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hernan Mejia-Renteria, MD

CONTACT

+34/913303438hmejiarenteria@gmail.com

Carolina Espejo Paeres, MD

CONTACT

+34/913303438carolina.espejo.paeres@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 16, 2019

First Posted

October 18, 2019

Study Start

March 1, 2017

Primary Completion

December 31, 2019

Study Completion

March 31, 2020

Last Updated

January 6, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)