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NCT Number: NCT04554004

A Non-invasive Index of Microciculatory Resistance

Coronary artery microvascular disease (CMVD) lacks reliable and non-invasive quantitative diagnosis methods. Improving coronary microcirculation has become one of the main goals of coronary heart disease treatment. In this study, by establishing the key influencing factors of myocardial microcirculation perfusion, an accurate three-dimensional reconstruction method of coronary artery was established, and a non-invasive coronary microcirculation resistance index (CT-IMR) calculation method based on computational fluid method mechanics was established. At the same time, a phase I single-center clinical verification and a multi-center clinical verification of the non-invasive coronary microcirculation function precision assessment system were carried out, and a non-invasive coronary microcirculation detection system and technology were established.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First People's Hospital of Hangzhou

Hanzhou, Zhejiang, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject must be older than 18 years
  • Written informed consent available
  • Subject is indicated for invasive coronary angiography
  • Subject need to be taken within 30 days after enrolment

Exclusion criteria

  • Previous PCI or CABG
  • Subject is not eligible for measuring IMR
  • Complicated complex congenital heart disease
  • Artificial pacemaker or internal defibrillator leads implanted
  • Implanted artificial heart valve
  • Severe arrhythmia including complete AV block, ventricular arrhythmia
  • Impaired chronic renal function (serum creatinine>1.5ULN)
  • Allergic to iodine
  • Pregnancy
  • Body mass index >35 kg/m2
  • Left ventricle is markedly thickened
  • Needs for emergency procedures
  • Severe distortion of in the blood vessel
  • Unstable haemodynamics including abrupt chest pain cardiogenic shock, unstable blood pressure (systolic < 90mmHg), severe congestive heart failure or pulmonary edema
  • Life-threatening diseases (life expectancy < 2 months)
  • Tako Tsubo syndrome (TTS)
  • Others who are inappropriate subject judged by clinician

Treatment and study plan

CCTA, CT-MPI, DSA, FFR

Diagnostic Test

The patients who enrolled the study will undergo coronary CT angiography(CCTA), dynamic CT-MPI, invasive coronary angiography and invasive computation of fractional flow reserve (FFR)

Primary outcomes

  1. sensitivity and specificity

    Time frame: up to 12 months

    The sensitivity and specificity of CT-IMR in the diagnosis of microcirculation dysfunction were studied.

Secondary outcomes

  1. diagnostic

    Time frame: up to 12 months

    To study the diagnostic coincidence rate, positive predictive value and negative predictive value of CT-IMR in the diagnosis of microcirculation dysfunction.

Sponsors and collaborators

Lead sponsor

First People's Hospital of Hangzhou

Other

Registry information

Official study title

A Clinical Trial for CT Myocardial Perfusion Based Non-invasive Index of Microciculatory Resistance

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 18, 2020
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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