The MASTER-PACT Study

NCT06069401 | Unknown

• 1 other identifier: NL84769.018.23
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to compare non-invasive myocardial perfusion reserve (MRR) to invasively measured MRR in patients suspected for coronary artery disease (CAD). The main question it aims to answer is: • what is the correlation and agreement between non-invasive and invasive MRR. Participants suspected for CAD and referred for invasive coronary angiogram (ICA) will receive a \[15O\]H2O-PET and coronary CT angiography preceding ICA. During ICA, microvascular resistance measurements will be performed using thermodilution.

Conditions

Microvascular Coronary Artery Disease; Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

• Correlation non-invasive and invasive MRR

  The first primary endpoint will be correlation between non-invasive and invasive MRR, indicated by Pearson/Spearman correlation.

  Immediately after the PET and CT scan (non-invasive MRR) and ICA (invasive MRR)

• Agreement non-invasive and invasive MRR

  The first primary endpoint will be agreement between non-invasive and invasive MRR, indicated by a Blant-Altman analysis.

  Immediately after the PET and CT scan (non-invasive MRR) and ICA (invasive MRR)

Secondary Outcomes (2)

• Correlation non-invasive and invasive resting and hyperemic resistance

  Immediately after the PET and CT scan (non-invasive MRR) and ICA (invasive MRR)

• Agreement non-invasive and invasive resting and hyperemic resistance

  Immediately after the PET and CT scan (non-invasive MRR) and ICA (invasive MRR)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chronic coronary syndrome patients without documented coronary artery disease (CAD) referred for ICA will be evaluated for inclusion.

You may qualify if:

• Referred for ICA because of suspected CAD
• No documented prior history of CAD
• Age ≥18 and ≤80 years old

You may not qualify if:

• Unstable CAD, Non-ST-Elevation Myocardial Infarction (NSTEMI), ST-Elevation Myocardial Infarction (STEMI), cardiogenic shock or hemodynamically unstable patients
• Patients with previous coronary artery bypass (CABG) surgery, PCI or myocardial infarction (MI)
• Tortuous or calcified coronary arteries, if known
• Coronary arteries with a small caliber (\<2,5 mm), if known
• Atrial fibrillation, second or third degree atrioventricular block or severe conduction disturbances with an indication for temporary or permanent pacing
• History of severe COPD or chronic asthma
• Renal failure ( i.e. eGFR \< 30 mL/min)
• Use of sildenafil (Viagra) or dipyramidol (Persantin) that cannot be terminated
• Contra-indications for β-blockers
• Allergic reaction to iodized contrast
• Pregnancy
• Inability to understand and give informed consent

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Roel Hoek, MD

CONTACT

+3120-4440381; roel.hoek@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. P. Knaapen

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: October 5, 2023
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: July 1, 2025
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share